POLICY FOR UNDERTAKING NEW INTERVENTIONAL PROCEDURES Authorising Officer

Dr. Geraldine O’Sullivan, Medical Director

Signature Of Authorising Officer: Version: Ratified By: Date Ratified: Name of originator/author: Name of responsible committee/lead individual:

V2 Quality and Best Value Committee 28th January 2009 Practice Standards Facilitator

Drugs and Therapeutic Committee Janet Howell, Head of Medicines Management Date issued: February 2009 Review date: March 2011 Summary: Medical practitioners planning to undertake new interventional procedures are required to follow the approval process specified in this document. Target audience: All HPFT Medical practitioners

Hertfordshire Partnership NHS Foundation Trust is committed to providing an environment where all staff, service users and carers enjoy equality of opportunity. The Trust works to eliminate all forms of discrimination and recognise that this requires, not only a commitment to remove discrimination, but also action through positive policies to redress inequalities. Providing equality of opportunity means understanding and appreciating the diversity of our staff, service users & carers and ensuring a supportive environment free from harassment. Because of this Hertfordshire Partnership NHS Foundation Trust actively encourages its staff to challenge discrimination and promote equality of opportunity for all.

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Version Control Version

Date

Author

Status

Comment

V1

March 06

S Judges

Superseded

Archived

V2

11.2.09

P Crosby

Current

Agreed DTC 19.1.09, Q&BVC 28.1.09, Trust Executive 3.2.09

National Standard Healthcare Commission Annual Health Check Standard C03 2008/09 Healthcare organisations protect patients by following NICE Interventional Procedures guidance. Element one – The healthcare organisation follows NICE interventional procedures guidance in accordance with The interventional procedures programme (Health Service Circular 2003/011). Arrangements for compliance are communicated to all relevant staff.

Comments and Feedback on this document were obtained from: Nice Co-ordinator Head of Medicines Management Drugs and Therapeutic Committee Equality Impact Assessment Scrutiny Group

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CONTENTS Section 1 2 3 4 5 6 7 8

Introduction The Trust Process The NICE Process Exceptions to the Process Adverse Events Consultation, Approval, Ratification and Archiving Process Process for monitoring compliance with this document Dissemination, Implementation and Access to this document 9 References 10 Associated Documentation Appendix 1 DoH – The Interventional Procedures Programme Equality Impact Assessment Stage One

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1. Introduction The National Institute for Clinical Excellence’s (NICE) Interventional Procedures Programme assesses the safety and efficacy of new interventional procedures. From 13 November 2003, medical practitioners planning to undertake new interventional procedures (see definitions below) are required to follow an approval process that is specified in HSC2003/011 (appendix 1). This policy details the approval process within Hertfordshire Partnership NHS Foundation Trust. Definitions

• An interventional procedure is classified by NICE as ‘used for diagnosis or treatment that involves incision, puncture, entry into a body cavity, electromagnetic or acoustic energy.’ • The procedure is considered to be new if ‘a doctor no longer in a training post is using it for the first time in his or her NHS clinical practice.’ 2. The Trust Process 2.1 Medical practitioners or other healthcare professionals intending to carry out an interventional procedure that he/she has not used before or has only used outside the NHS, should seek the prior approval of the Drugs and Therapeutics Committee on behalf of the Integrated Governance Group. The Drugs and Therapeutics committee may choose to seek advice from any of its sub-committees or other trust groups at any point in this process. 2.2 If the procedure is the subject of NICE guidance, the Drugs and Therapeutics committee will consider whether the proposed use of the procedure complies with the guidance before approving it. 2.3 If there is no existing NICE guidance the Chair of the Drugs and Therapeutics committee will then notify the procedure to NICE via their website (www.nice.org.uk/ip). NICE will then take the steps outlined in Section 3, below. 2.4 If there is no existing guidance on the procedure the Drugs and Therapeutics committee will only approve its use if: •

the doctor has met externally set standards of training.

•

All service users offered the procedure are made aware of the special status of the procedure and the lack of experience of its use. This should be done as part of the consent process and should be clearly recorded. Service users need to understand that the procedure’s safety and efficacy is uncertain and be informed about the anticipated benefits and possible adverse effects of the procedure and alternatives, including no treatment.

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This may require the use of interpreters or other communication support for people with additional needs such as physical, sensory or learning disabilities, and people who do not speak or read English. Refer to the Trust policy on Communicating with Diverse Communities. •

The Drugs and Therapeutics committee is satisfied that the proposed arrangements for clinical audit are sound and will capture data on clinical outcomes that will be used to review continued use of the procedure.

2.5 Decisions will be reported to the HPFT Quality and Best Value group by the Head of Medicines Management. 3. The NICE Process 3.1 Once notified of a new interventional procedure, NICE will prepare a brief overview of the evidence on the procedure’s safety and efficacy and consult its Specialist Advisors. 3.2 A NICE advisory committee will decide either to issue guidance on the procedure or to seek more information before doing so. As part of this process, NICE may commission a systematic review of research on the procedure, or set up a national register to collect data about patients who have been treated with it. 3.3 NICE consults publicly on all its guidance and its advisory committee will consider responses to consultation before guidance on any procedure is issued. 4

Exceptions to the Process

4.1 The only exception to the above process is when the procedure is being used only within a protocol approved by a Research Ethics Committee (REC). In this case notification to NICE is not needed, as service users are protected by the REC’s scrutiny. 4.2 In these cases the Drugs and Therapeutics committee should be notified by the REC when they approve a protocol covering an interventional procedure. Any use outside the protocol should only occur after approval from the Drugs and Therapeutics committee as set out in Section 2. 5. Adverse Events If an adverse event occurs in association with a new interventional procedure, this should be reported in the usual way, via the Trust’s Learning from Adverse Events Policy. 6. Consultation, Reviewing, Approval, Ratification and Archiving Process

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6.1 This policy has been circulated for comments to Lead Clinicians. The document has been agreed by the HPFT Drugs and Therapeutics committee and ratified by the Quality and Best Value Committee. 6.2 This policy will be reviewed annually or whenever national policy or guideline require to be considered (whichever occurs first), by the author. 6.3 The policy is retained and archived as set out in the Trust document, “The development and management of procedural documents.” 7. Process for monitoring compliance with this document The process will be monitored by the Head of Medicines Management. 8. Dissemination, Implementation and Access to this document This policy is disseminated throughout the Trust following ratification via the policy guardians. and will be published on the HPFT staff website. Access to this document is open to all via the Trust public website. It is the responsibility of all medical practitioners and other healthcare professionals to follow the requirements of this policy. 9. References Health Service Circular 2003/011 (attached as Appendix 1) Healthcare Commission Annual Health Check Standard C032008/09 www.healthcarecommission.org.uk/homepage.cfm 10.

Associated Documentation NICE Implementation Guidance in HPFT

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, DH) Department of Health Appendix 1

Health Service Circular Series Number: Issue Date: Review Date: Category: Status:

HSC 2003/011 13 November 2003 12 November 2005 Clinical Effectiveness Action sets out a specific action on the part of the recipient with a deadline where appropriate

The Interventional Procedures Programme Working with the National Institute for Clinical Excellence to promote safe clinical innovation

For action by:

NHS Trusts - Chief Executives

For information to:

NHS Trusts - Chairman Primary Care Trusts - Chief Executives Medical Schools - Deans Medical Directors Directors of Nursing National Care Standards Commission National Patient Safety Agency Commission for Health Improvement

Further details from: Paul Woods Department of Health Room 415 Wellington House 133/155 Waterloo Road London SE18UG 0207972 4811 paul. [email protected] Additional copies of this document can be obtained from: Department of Health PO Box 777 London SE16XH Fax 01623 724524 It is also available on the Department of Health web site at http:/www.doh.gov.uk/publications/coinh.html

© Crown copyright 13 November 2003

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HSC2003/011

Health Service Circular

The Interventional Procedures Programme Working with the National Institute for Clinical Excellence to promote safe clinical innovation 1. From 13 November 2003, medical practitioners planning to undertake new interventional procedures (see definition on page 4) should seek approval from their NHS Trust's Clinical Governance Committee before doing so. The Chair of the Clinical Governance Committee should notify the procedure to the Interventional Procedures Programme at the National Institute for Clinical Excellence (NICE) unless it is already listed there. In a case where the procedure has to be used in an emergency (see below) the procedure should be notified to the Clinical Governance Committee within 72 hours. 2. The only exception to the process is when the procedure is being used only within a protocol approved by a Research Ethics Committee (REC). Purpose of the Programme 3. NICE's Interventional Procedures Programme assesses the safety and efficacy of new interventional procedures. The programme's aims are to protect the safety of patients and to support doctors, other clinicians, Clinical Governance Committees, healthcare organisations and the NHS as a whole in managing clinical innovation responsibly. How the programme works 4. Medical practitioners intending to carry out a new interventional procedure should seek the approval of their NHS Trust's Clinical Governance Committee. Ifthe procedure is not listed on NICE's website (www.nice.org.ukJip), the Chair of the Committee should notify the procedure to NICE via the website. A new notification will initiate the following procedure: •

NICE will prepare a brief overview of the evidence on the procedure's safety and efficacy and consult its Specialist Advisors

•

a NICE advisory committee will decide either to issue guidance on the procedure or to seek more information before doing so. As part of this process, NICE may commission a systematic review of research on the procedure, or set up a national register to collect data about patients who have been treated with it

•

NICE consults publicly on all its guidance and its advisory committee will consider responses to consultation before guidance on any procedure is issued.

5. Patients, managers, commissioners and others can also notify procedures directly to NICE through its website. What the NHS should do 6. The success of the Interventional Procedures Programme is dependent on appropriate engagement from the NHS. 7. Any doctor considering use in the NHS of a new interventional procedure which he/she has not used before, or only used outside the NHS, should seek the prior approval of 13 November 2003

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Health Service Circular

HSC2003/011

their NHS Trust's Clinical Governance Committee. If the procedure is the subject of NICE guidance, the Committee should consider whether the proposed use of the procedure complies with the guidance before approving it. 8. If no NICE guidance on the procedure is available, the Committee should only approve its use if: • the doctor has met externally set standards of training •

all patients offered the procedure are made aware of the special status of the procedure and the lack of experience of its use. This should be done as part of the consent process and should be clearly recorded. Patients need to understand that the procedure's safety and efficacy is uncertain and be informed about the anticipated benefits and possible adverse effects of the procedure and alternatives, including no treatment

•

the Committee is satisfied that the proposed arrangements for clinical audit are sound and will capture data on clinical outcomes that will be used to review continued use of the procedure.

9. The Committee should also take account of the Clinical Negligence Scheme for Trusts standard 5.2.6. 10. It is recognised that in rare circumstances, where no other treatment options exist, there may be a need to use a new procedure in a clinical emergency so as not to place a patient at serious risk. If a doctor has performed a new interventional procedure in such circumstances he/she must inform the Clinical Governance Committee within 72 hours. The Committee will consider approval of the procedure for future use as above. 11. When NICE is collecting data under this Programme, doctors should supply the information requested on every patient undergoing the procedure. NHS Trusts are encouraged to support this to enable the NHS to have access more speedily to guidance on the procedure's safety and efficacy. The collection of data from patients will be governed by the Data Protection Act. 12. The only exception to the above process is when the procedure is being used only within a protocol approved by a Research Ethics Committee (REC). In this case, notification to NICE is not needed, as patients are protected by the REC's scrutiny. However, RECs should notify Trust Clinical Governance Committees when they approve a protocol involving an interventional procedure. Use outside the protocol should only occur after approval from the Clinical Governance Committee as set out above. 13. If an adverse incident occurs in association with a new interventional procedure, this should be reported to the National Patient Safety Agency in the normal way via the national reporting and learning system for adverse events to be implemented across the NHS in 2003. 14. CHI's review teams assess how well clinical governance is working in Trusts by making enquiries about each of the seven components of clinical governance at corporate and directorate levels and in clinical teams. This involves collecting information systematically about review issues and will include how Trusts' Clinical Governance Committees introduce new interventional procedures. Page 3

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Health Service Circular

Definitions

15. An interventional procedure is one used for diagnosis or treatment that involves incision, puncture, entry into a body cavity, electromagnetic or acoustic energy. 16. An interventional procedure should be considered new if a doctor no longer in a training post is using it for the first time in his or her NHS clinical practice. Associated Documentation 17. Further information can be found on the NICE website www.nice.org.uk/ip and the Programme can be contacted via [email protected] This Circular has been issued by:

Professor Aidan Halligan Deputy Chief Medical Officer 13 November 2003

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Stage One - Equality Impact Assessment Policy or service being assessed: Policy For Undertaking New Interventional Procedures Summary of Policy: From 13 November 2003, medical practitioners planning to undertake new interventional procedures (see definitions below) are required to follow an approval process that is specified in HSC2003/011 (appendix 1). Lead Person: P Crosby, Practice Standards Facilitator Date of Assessment: November 2008 1. Is this a new or existing policy or New: Existing: X service? 2. What is the expected outcome of the Service users are assured that the Drugs service/policy (e.g. aims, objectives and and Therapeutics Committee has vetted purpose of the service/policy, standards for any new interventional procedures carried practice) out in the Trust. Yes: X No: 3. Does this policy/service link to others? If yes please state link below: Introduction of Therapeutic Approaches & Techniques 4. Does the Policy/Service show that the 11 Yes: X No: principles of mental health recovery have been taken into account? If yes, please give evidence: Principle 10. Recovery is evidence based and effective 5. Who is intended to benefit from the Staff have a framework in which to policy/service: In what way. practice, and the Trust has an assurance framework. 6. How is the policy/service to be put into The responsibility for implementation is via practice? Who is responsible? HPFT Medical Practitioners. 7. How and where is information about the The policy is distributed via the policy policy/service publicised? guardians and available on the staff and public website. 8. What regular consultation do you carry out No specific consultation. with different communities and groups re the policy/service? 9. Are there concerns that the policy/service Yes: No: could have an adverse impact* because of: Age X Disability X Gender X Ethnicity X Sexual Orientation X Religion/Belief X 10. If YES to one or more of the above please state evidence. 11. Do the differences amount to discrimination?* 12. If YES could it still be justifiable e.g. on grounds of promoting equality of opportunity for one group? I.e. Indirect discrimination can be justifiable

N/A Yes:

No: N/A

Yes:

No: N/A

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14 August 2009

sometimes when a service is being provided for a particular target group E.g. Asian women’s breast screening, Gay men’s sexual health clinic, Mental Health Services for Older People etc. If Yes: Please give reasons below: N/A 13. Do you think this policy/service specifically contributes to promoting equality and diversity in Hertfordshire? If so, in what way? Please note any examples of good practice. 14. What approaches will you take to get feedback on your assessment? 15. How will the assessment link to other mainstream service planning or review processes? 16. Should there now be a Full Impact Assessment and if so what are the reasons? 17. What further data, information or assistance do you need to carry out a full assessment?

Not specifically.

Feedback from the Trust EIA group. Links to the Healthcare Commission Annual Health Check Standard C032008/09 There is no evidence in Stage One that a full impact assessment is required. N/A

Agreed by the Trust EIA Scrutiny group on 27.11.08.

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14 August 2009