NICE - Portsmouth Hospitals NHS Trust

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This policy applies to all healthcare professionals involved in the clinical .... areas of partial or non-compliance are monitored and added to the CSC Risk ...


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NICE GUIDANCE/QUALITY STANDARDS POLICY FOR THE ASSURANCE OF IMPLEMENTATION

|Version |5 | | |Name of responsible (ratifying) |Clinical Effectiveness Steering Group | | |committee |(CESG) | | |Date ratified |21 January 2015 | | |Document Manager (job title) |Clinical Audit and Assurance Manager | | |Date issued |13 February 2015 | | |Review date |31 January 2018 | | |Electronic location |Management Policies | | |Related Procedural Documents |Policy for the Introduction of New Clinical| | | |Procedures, Interventions and Techniques. | | | |Risk Assessment Policy and Protocol. | | |Key Words (to aid with searching) |NHSLA; Care Quality Commission; Quality | | | |Contract; | | | |NICE; Technology Appraisal Guidelines; | | | |Interventional Procedures Guidance; | | | |Clinical Guidelines; NICE Implementation; | | | |NICE Compliance; medical device; diagnostic| | | |technique; surgical procedure; Drug, | | | |Intervention; Cancer; Tumours; Clinical | | | |Audit; Monitoring; Governance; Corporate | | | |management; Trust law; Trusts; | | | |Technological innovations; Technology; Drug| | | |administration; Drug regulations; Audit; | | | |Review bodies; Performance measurement; | | | |Medical interventions; Medical equipment; | | | |Clinical guidelines; Medical Technologies; | | | |Diagnostic Technologies; Patient Safety; | | | |Quality Standards; Public Health | | | |Intervention; NHS Evidence; | |

Version Tracking |Version |Date |Brief Summary of Changes |Author | | |Ratified | | | |5 |21/01/2015 |Review/revision updating with new types |D Williams | | | |off NICE guidance including NICE | | | | |Quality Standards/ Medical Technologies | | | | |Diagnostic Technologies/NICE Safe | | | | |Staffing Guidance | | | | | | |

CONTENTS

Page

QUICK REFERENCE 3

1. INTRODUCTION 4

2. PURPOSE 4

3. SCOPE 4

4. DEFINITIONS 4

5. DUTIES AND RESPONSIBILITIES 5

6. PROCESS 7

7. TRAINING REQUIREMENTS 9

8. REFERENCES AND ASSOCIATED DOCUMENTATION 9

9. EQUALITY IMPACT ASSESSMENT 9

10. MONITORING COMPLIANCE 10

Appendices

Appendix A - Baseline Compliance Review TAG 11

Appendix B - Baseline Compliance Review IPG 13

Appendix C - Clinical and Cancer Guideline Self-assessment Checklist 15

Appendix D - Quality Standards Gap Analysis 17













QUICK REFERENCE

NICE Implementation Flow Chart [pic]

INTRODUCTION

Portsmouth Hospitals NHS Trust (the Trust) has a responsibility for implementing National Institute for Health and Care Excellence (NICE) guidance in order to ensure that:

• Patients receive the best and most appropriate treatment; • NHS resources are not wasted by inappropriate treatment; and • There is equity through consistent application of NICE guidance/Quality Standards.

The Trust must demonstrate to stakeholders that NICE guidance/Quality Standards are being implemented within the Trust and across the health community. This is a regulatory requirement which is subject to scrutiny by the CQC. Assurance of compliance is also required as part of the NHS standard Acute Services Contract.

The Trust is required to comply with 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 set out the Trust processes for implementing, monitoring and reporting progress in relation to NICE guidance and Quality Standards, thus ensuring continual improvement in the quality of services provided against evidenced best practice standards.

SCOPE

This policy applies to all healthcare professionals involved in the clinical management of patients who receive services from the Trust.

In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety.

DEFINITIONS

National Institute for Health and Care Excellence (NICE): NICE is an independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health.

Clinical and Cancer Guidelines (CGs): give recommendations of good practice based on the best available evidence and the appropriate treatment and care of people with specific diseases and conditions. They may focus on any aspect such as prevention, self-care, or management in primary and secondary care.

Interventional Procedure Guidance (IPG): make recommendations about whether interventional procedures used for diagnosis or treatment are safe enough and work well enough for routine use and whether special arrangements are needed for patient consent.



Technology Appraisal Guidance (TAG): provides recommendations on the use of new and existing health technologies within the National Health Service. Each TAG focuses on pharmaceutical and biopharmaceutical products, but also includes procedures, devices and diagnostic agents. This is to ensure that all NHS patients have equitable access to the most clinically - and cost-effective treatments that are viable.

Medical Technologies Guidance (MTG): designed to help the NHS adopt efficient and cost effective medical devices more rapidly and consistently.

Diagnostic Technologies Guidance (DTG): designed to help the NHS adopt efficient and cost effective diagnostic technologies more rapidly and consistently.

Patient Safety Guidance (PSG): provides advice on patient safety solutions.

NICE Quality Standards (QS): are a set of specific, concise statements that act as markers of high quality, cost-effective patient care, covering the treatment and prevention of different diseases and conditions. Derived from the best available evidence such as NICE guidance and other evidence sources accredited by NHS Evidence, they are developed independently by NICE, in collaboration with the NHS and social care professionals, their partners and service users, and address three dimensions of quality: clinical effectiveness, patient safety and patient experience.

Public Health Intervention Guidance (PHIG): gives guidance on the promotion of good health and the prevention of ill health. The guidance may focus on a particular topic (such as smoking), a particular population (such as schoolchildren) or a particular setting (such as the workplace).

NICE Safe staffing guidelines The National Quality Board has set out the immediate expectation of NHS providers in providing safe staffing levels. This guidance is a comprehensive review of the evidence in this area and produce definitive guidelines on safe staffing to support local decisions at ward and organisational level.

Self-assessment Checklist for CGs: is an organisational gap analysis against the guidance recommendations to enable an action plan to be developed and prioritised to achieve full compliance.



Organisational Gap Analysis: is a review of actual current practice against the NICE recommendations, producing an action plan where gaps are identified to align current practice with the identified best practice recommendations.



Baseline Compliance Review (BCR): is an initial position statement from the specialty clinical lead, detailing the level of compliance with the published NICE guidance excluding Clinical and Cancer Guidelines (CGs).

NICE social care guidelines The primary role of NICE social care guidelines is to provide recommendations on “what works” in terms of both the effectiveness and cost-effectiveness of social care interventions and services.

NHS Evidence: is a service that enables access to authoritative clinical and non-clinical evidence and best practice through a web- based portal (http://www.evidence.nhs.uk ). It helps people from across the NHS, public health and social care sectors to make better decisions as a result. NHS Evidence is managed by NICE.

DUTIES AND RESPONSIBILITIES

Clinical Effectiveness Steering Group (CESG) The CESG has overall responsibility for monitoring the status of NICE guidance/Quality Standards and receiving a quarterly NICE implementation status report from the Clinical Audit and Assurance Manager to ensure that, through the appropriate monitoring of that implementation, the Trust can demonstrate care against best evidence, best practice guidance to assure the continuous and measurable improvement in the quality of the services provided.



Clinical Service Centre Governance Committees (CSCGC) CSCGCs have the responsibility to ensure that they are aware of NICE guidance/Quality Standards that impact on their areas and that all action plans to address areas of partial or non-compliance are monitored and added to the CSC Risk Register, escalating any issues of concern to the CSC Management Team and through their quarterly reports to the Governance and Quality Committee.

Clinical Service Centre Management Teams (CSCMT) CSCMTs are responsible for receiving and acting upon any information from the CSCGCs, concerning barriers to the implementation of NICE guidance/Quality Standards.

Senior Management Team meeting (SMT) As a sub-group of the Trust Board, SMT will identify if funding is available for NICE related business cases, ensuring that guidance can be aligned with the Trust planning processes and that there is appropriate liaison with relevant CCG partners.

Medical Director (MD) The MD, who also chairs CESG, has delegated responsibility to ensure that NICE guidance/Quality Standards is appropriately implemented across the Trust and that the Trust Board is made aware of any issues that may impact upon the organisation’s ability to do so.

CSC Governance Leads The CSC governance leads will receive details of all new and proposed NICE publications from the NICE Co-ordinator and will identify relevant leads within the organisation to complete the initial BCR/Self- assessment checklist or gap analysis as appropriate. The CSC governance leads will be responsible for ensuring that appropriate and timely action is taken in response to any issues identified, through the CSC governance structure or by escalation to the CESG.

The CSC governance leads have responsibility to ensure that their CSCs are aware of NICE guidance/Quality Standards and to ensure that there is robust evidence to give assurance of implementation of that guidance. They are also responsible for ensuring that any identified issues of partial or non-compliance are escalated to the CSC Governance meeting and that any barriers to implementation and compliance, are risk assessed and added to the appropriate CSC risk register.

Clinical Audit and Assurance Manager The Clinical Audit and Assurance Manager has responsibility for the operational and day-to-day implementation of this policy, including the escalation of any identified issues to the CSC governance leads or CESG. The Clinical Audit and Assurance Manager will ensure that the CESG receive a quarterly status summary report giving the overall Trust position of compliance with NICE guidance/Quality Standards.

NICE Coordinator The NICE coordinator is responsible for the coordination and distribution of new NICE guidance/Quality Standards to the CSC governance leads, providing support and advice to relevant staff and assisting the Clinical Audit and Assurance Manager, including escalating any issues identified. The NICE coordinator will also maintain the NICE database on the Trust’s Intranet together with evidence to support compliance or non-compliance.

Identified Leads The identified leads have responsibility for ensuring that an initial BCR/Self-assessment checklist or gap analysis review is undertaken for any NICE guideline/Quality Standard for which they have been identified by the CSC governance leads or CESG as the lead. This will include utilising implementation and costing tools provided by NICE, to assist in understanding the financial and clinical impact of the guidance, developing business cases, ensuring that any relevant guidance is disseminated appropriately within the Trust and or specialty, where the guidance impacts, liaising with other relevant stakeholders.

The identified leads are also responsible for formulating a robust action plan to address any areas of partial or non-compliance and sharing these with the CSC governance leads for monitoring at the CSCGC. Where declarations of partial or non-compliance are made the identified lead will undertake a risk assessment and escalate that assessment to the CSCGC for consideration of placement on the CSC or trust risk register.

In addition, the identified leads will ensure that audits of relevant NICE guidance/Quality Standards are added to the specialty rolling annual audit plans and that those audits are registered with the Clinical Audit Department (CAD) and undertaken to timescale.

Healthcare Professionals All healthcare professionals are responsible for ensuring that they familiarise themselves, and comply with, the requirements of this policy and the associated Policy for the Introduction of New Clinical Procedures, Interventions and Techniques.

Healthcare professionals are also expected to take NICE guidelines into account when exercising their clinical judgement. The guidance does not, however, over-ride the responsibility of healthcare professionals to make decisions appropriate to the circumstances of each patient, in consultation with the patient. Where treatment is given outside of the guidelines, healthcare professionals must fully document the reasons for non-compliance in the patient’s medical records.

5.1: Trust Pharmaceutical Services

1. Director of Medicines Management and Pharmacy will receive NICE guidance and identify if guidance is relevant to the Trust or if the Clinical Commissioning Groups (CCGs) are required to be involved. They will ensure an outline business case is developed in conjunction with the CSC pharmacist for submission to the relevant committee. All business cases will include a requirement for regular audit. 2. Formulary Interface Pharmacist will liaise with the NICE coordinator to ensure the relevant database is kept updated. 3. Formulary and Medicines Group (FMG) will review guidance that impacts the Trust and escalate any business cases to SMT if the cost impact is likely to be greater than £20,000. Guidance will also be referred to the Area Prescribing Committee for noting and to approve any changes to the Portsmouth District Prescribing Formulary. The FMG will report progress on any NICE related medicine reviews to the Governance and Quality Committee via their bi-annual report. 4. Area Prescribing Committee (APC) will review all guidance that affects both the Trust and the CCGs and will record any action arising; this includes updating of the District Prescribing Formulary or confirmation that no action is required. If a business case is approved by the APC and / or the financial impact to the Trust is greater than £20,000, the APC will inform the SMT.

PROCESS

6.1 Identifying and disseminating relevant documents

6.1.1 The NICE Coordinator will receive the monthly alert sent by NICE each month.

6.1.2 Within 14 working days following publication the NICE coordinator places the newly issued guidance onto the NICE database, therefore ensuring it is available to all members of staff through the clinical audit intranet.

3. Within 14 working days, the NICE coordinator forwards the guidance to all CSC governance leads, to enable an identified lead to be appointed.

4. The NICE coordinator forwards to the identified lead the appropriate BCR/Self-assessment checklist or gap analysis review forms for completion (Appendix A, B, C, D); to ensure an initial position statement of compliance, within the spirit of the guidance/Quality Standard is received into the CAD.

1. Conducting an organisational gap analysis

1. The identified lead will undertake an organisational gap analysis by completion of a BCR/Self-assessment checklist or gap analysis review and forward that analysis to the CAD. The identified lead will also produce an action plan with timescales to ensure full compliance is achieved.

2. The NICE Coordinator will update the NICE database and if any area of partial or non-compliance is reported, the NICE coordinator will inform the identified lead that a risk assessment is required.

3. The Clinical Audit and Assurance Manager will escalate any identified issues or barriers to implement to the CESG.



2. Ensuring that recommendations are acted upon throughout the organisation Once the organisational gap analysis has been completed by the identified lead, the Trust has the following process in place to ensure that recommendations are acted upon

















































3. Recording of any decisions not to implement NICE guidance/Quality Standards

1. The identified lead undertakes a BCR/Self-assessment checklist or gap analysis review in consultation with colleagues. Any decision not to implement and why, is referred to CESG.

2. The decision not to implement, and why, is validated by the CESG

3. The identified lead will ensure that any risk posed by non- implementation is assessed and placed on the CSC risk register, as necessary.

4. The Medical Director will escalate any decisions not to implement NICE guidance/Quality Standards to the Trust Board.

5. Once the board validates the non-implementation, any associated risks will be escalated to the Trust Risk Register.

6. The NICE Coordinator will contact the identified leads on a six monthly basis in order to determine whether there are any changes in the decision not to implement the guidance. The NICE coordinator will then update the database accordingly.



TRAINING REQUIREMENTS

There are no specific training requirements associated with this procedural document. Advice and guidance can be sought from CSC Governance Leads or the NICE coordinator on extension: 7700 5992.



REFERENCES AND ASSOCIATED DOCUMENTATION

External CQC Essential Standards Interventional procedures programme process guide (http://www.nice.org.uk/Process Guide). Interventional procedures programme methods guide (http://www.nice.org.uk//The-interventional-procedures-programme- methods-guide). Department of Health, Health Service Circular HSC 2003/011 www.dh.gov.uk How to put NICE guidance into practice www.nice.org.uk

Internal Policy for the Introduction of New Clinical Procedures, Interventions and Techniques Risk Assessment Policy and Protocol Clinical Audit Policy

EQUALITY IMPACT ASSESSMENT

Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds.

This policy has been assessed accordingly.

MONITORING COMPLIANCE

As a minimum the following will be monitored to ensure compliance

|Element to be |Lead |Tool |Frequency of |Reporting |Acting on | |monitored | | |Reporting of |arrangements |recommendations and| | | | |Compliance | |Lead(s) | |Process for |NICE |Review of NICE |Annually |Policy Audit Report|Clinical Audit and | |disseminating |Coordinat|spreadsheet | |to: |Assurance Manager | |relevant documents |or | | |Clinical | | |95% of documents | | | |Effectiveness | | |will be disseminated| | | |Steering Group | | |within 14 days of | | | | | | |publication | | | | | | |Process for |NICE |Review of NICE |Annually |Policy Audit Report|Clinical Audit and | |conducting an |Coordinat|spreadsheet | |to: |Assurance Manager | |organisational gap |or | | |Clinical | | |analysis: 100% of | | | |Effectiveness | | |relevant documents | | | |Steering Group | | |will undergo a gap | | | | | | |analysis | | | | | | |Process for ensuring|NICE |Review of NICE |Annually |Policy Audit Report|Medical Director | |that recommendations|Coordinat|spreadsheet | |to: | | |are acted upon |or | | |Clinical | | |throughout the | | | |Effectiveness | | |organisation | | | |Steering Group | | |95% of | | | | | | |recommendations will| | | | | | |be implemented | | | | | | |within the given | | | | | | |timescales | | | | | | |Process for |NICE |Review of NICE |Annually |Policy Audit Report|Medical Director | |documenting any |Coordinat|spreadsheet | |to: | | |decision not to |or | | |Clinical | | |implement NICE | | | |Effectiveness | | |recommendations | | | |Steering Group | | |100% of such | | | | | | |recommendations will| | | | | | |have an associated | | | | | | |rationale and | | | | | | |documented Trust | | | | | | |Board agreement | | | | | |









































Appendix A

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Appendix A (cont.)





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Appendix B

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Appendix B (cont.)







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Appendix C





[pic] Appendix C (cont.)



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Appendix D - Quality Standards Gap Analysis

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Appendix D (cont.)











Dear

As you may be aware the NICE Quality Standard relating to ________________ has now been issued.

As you have been identified as the most appropriate lead for this standard, I would be most grateful if you could complete the attached gap analysis form and return by ___________ at the latest.  This will then be presented and discussed at the Clinical Effectiveness Steering Group meeting on the ____________.



ADD GAP ANALYSIS

ADD FULL STANDARD



Many thanks and kind regards



NICE Co-ordinator

----------------------- NICE Coordinator to add guidance to database

New and proposed NICE guidance received via NICE alert email

Identified Lead to review document and return BCR to NICE Co-ordinator stating their compliance

• Governance leads to make decision to whom to send guidance. • NICE Coordinator to distribute relevant documents (BCR) to identified lead.



NO

YES

NICE Coordinator to update database

Fully Compliant

• Identified Lead ensures audit is planned on forward audit plan. • NICE coordinator to update database • Two yearly review

Partially Compliant

• For inclusion in report to CESG • Two yearly review

Relevant to the Trust?

Non Compliant

• Submit action plan to ensure compliance, including details of any business case. • Add to risk register • CSC governance leads ensure issues are monitored at CSC governance meetings • 6 monthly review for partial / non compliant • For inclusion in report to CESG.

Relevant to the Trust?

YES

YES

NO

NICE Coordinator to update database

Fully Compliant

Non Compliant

Partially Compliant

• Validated at CSCGC • Included in the quarterly report to CESG • Two yearly review by identified lead, to ensure the guidance remains of no relevance to the Trust

• The identified lead produces an action plan to achieve compliance • NICE Coordinator updates database • The action plan is forwarded to CSC Governance Lead • CSC Governance Leads ensure that issues are discussed at CSCGC and ensures that any partial/non-compliance is placed on CSC/trust risk register, together with the action plan • Risk Registers are monitored at CSCGC to ensure progress against action plans • Any barriers to progress will be escalated to CSC Management Team • CSC Governance Leads will feedback to CAD on a monthly basis.

• Compliance validated by CSCGC • NICE Coordinator updates database • Identified lead ensures that audit of compliance forms part of the rolling annual audit plan, registered with the CAD • Results of audit forwarded to the CAD, to update the database • NICE Coordinator will also ensure that two yearly monitoring reviews are undertaken for this guidance.



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