New Interventional Procedures: Introduction to UCLH

Transcription

1 New Interventional Procedures: Introduction to UCLH UCLH policy Policy number 014/CLN/T Issue number 2 Issue date 21/06/18 Approved by Policy Approval Sub Group Responsible Director Corporate Medical Director Policy Authors Clinical Effectiveness Coordinator Chair of the Clinical Effectiveness Steering Group Review Body Clinical Effectiveness Steering Group Documents to read in conjunction with this policy UCLH procedure for producing patient information UCLH NICE guidance implementation and monitoring policy Complete review by 31/05/21 date If reading a printed copy, always check that it is the most recent approved version. This can be found on the Policies & Procedures page on Insight.

2 List of reviewers & contributors Include here whether Counter Fraud; Infection Control Team or Interserve Facilities Management (IFM) were asked to review the policy and if comments were received Summary of main points from consultation Review body Author to complete Date of meeting when PASG approved the policy Clinical Effectiveness Coordinator, Quality and Safety Department UCLH Patient Information Coordinator Head of Quality, Quality and Safety Department Head of Safety, Quality and Safety Department Head of Legal Services, Quality and Safety Department Head of Staff Services Clinical Effectiveness Steering Group Chair, Deputy Divisional Clinical Director, Queen Square Clinical Effectiveness Steering Group members Corporate Medical Director Policy Approval Sub-Group members (PASG) Director for Quality and Safety Risk Systems & Development Manager Pre-trial new interventional procedure process and application forms which were approved by CESG and QSC to be added to policy; current processes in UCLH policy for NICE guidance to be reflected; patient information leaflet (PIL) section to be slightly amended to reflect that draft PILs may be submitted to CESG; The Trust to be replaced by UCLH; section on novel procedures removed; updated Appendix F; sections for emergency and compassionate use of new IPs merged to ensure both have equally robust approval process; other minor changes to reflect current practice; minor grammatical and formatting improvements; accurately described the implications for clinicians who do not follow the policy when introducing new procedures; added a section and an Appendix to describe the process to follow for retrospective applications and Datix reporting; included retrospective applications in the roles and responsibilities sections for clinical lead, DCD and Clinical Effectiveness Coordinator; amended the process for emergency or compassionate use of new interventional procedures in line with Corporate Medical Director request to add a process whereby all in the clinical team or speciality group are in agreement and have signed a letter which must be filed in the patient s case notes, clarified what items should be included in this agreement letter and that outcomes data is required; additional minor amendments made (in line with PASG comments and discussion with the Director for Quality and Safety) including amendment of the monitoring table and Appendix F; added clarification that CESG approvals are always only for the clinicians who are listed in the new interventional procedure application form to undertake the procedure and that only once CESG considers the interventional procedure to be an established procedure and no longer new the local governance group can then approve additional clinicians to undertake the interventional procedure; clarified that a draft PIL may be submitted to CESG for comment/suggestions as long as the finalised PIL is then approved by the divisional patient information readership panel before the new interventional procedure is undertaken; added local governance group in duties and responsibilities section. Added a section to the new interventional procedure application forms to ascertain conflict of interest. Clinical Effectiveness Steering Group 09/01/18 (approved subject to changes) Date of meeting when policy reviewed and endorsed: 08/12/2017 and 08/06/2018 UCLH ii

3 Review amendment log Version No Date amendments made 2 November 2017 draft policy seen by Jan-18 PASG 2 January 2018 to June 2018 draft policy Environmental Description of changes Policy updated to include: a) process for pre-trial new interventional procedures (process approved by CESG and QSC) b) changes in the revised NICE guidance implementation and monitoring policy c) expanded list of definitions and acronyms d) amended process to ensure both emergency and compassionate use of new IPs have equally robust approval process. e) revising patient information leaflet (PIL) section to reflect that a draft PIL can be presented to CESG prior to it being reviewed and approved by the divisional patient information lead and readership panel allowing for a more streamlined process. f) flowcharts revised and/or added. Section on novel procedures deleted as it falls within the scope of new interventional procedures. Sentence deleted from Appendix F as this policy is no longer singled out and specified in the job descriptions of all new consultant medical staff. Other minor changes made to reflect current practice. Accurately described the implications for clinicians who do not follow the policy when introducing new procedures. Added a section and an Appendix to describe the process to follow for retrospective applications and Datix reporting. Included retrospective applications in the roles and responsibilities sections for clinical lead, DCD and Clinical Effectiveness Coordinator. Amended the process for emergency or compassionate use of new interventional procedures in line with Corporate Medical Director request to add a process whereby all in the clinical team or speciality group are in agreement and have signed a letter which must be filed in the patient s case notes, clarified what items should be included in this agreement letter and that outcomes data is required Additional minor amendments made (in line with Jan-18 PASG comments and discussion with the Director for Quality and Safety) including amendment of the monitoring table and Appendix F; added clarification that CESG approvals are always only for the clinicians who are listed in the new interventional procedure application form to undertake the procedure and that only once CESG considers the interventional procedure to be an established procedure and no longer new the local governance group can then approve additional clinicians to undertake the interventional procedure; clarified that a draft PIL may be submitted to CESG for comment/suggestions as long as the finalised PIL is then approved by the divisional patient information readership panel before the new interventional procedure is undertaken; added local governance group in duties and responsibilities section. Added a section to the new interventional procedure application forms to ascertain conflict of interest. Do you really need to print this document? Please consider the environment before you print this document and where possible copies should be printed double-sided. Please also consider setting the Page range in the Print properties to avoid printing the policy in its entirety. UCLH iii

4 Table of contents Page Numbers 1. Summary 2 2. Equality Impact Assessment 2 3. Introduction 2 4. Objectives 3 5. Scope 3 6. Definitions and acronyms 3 7. Duties and Responsibilities 5 8. Introduction of new interventional procedures to UCLH 8 9. Post approval assurances Modification to existing procedures and implants New site and/or indication of existing interventional procedure Emergency or compassionate use of a new interventional procedure for 14 named patients 13. Pre-trial new interventional procedures Research Medical devices Retrospective applications for new interventional procedures Monitoring and Audit References 19 Appendices A Application to introduce a new interventional procedure 20 B Appeals process 26 C1 New interventional procedure application process flowchart 27 C2 New interventional procedure approval process flowchart 28 D Application to introduce a pre-trial new interventional procedure 29 E1 Pre-trial new interventional procedure application process flowchart 36 E2 Pre-trial new interventional procedure approval process flowchart 37 F Governance framework and policy assurance 38 G Reporting an incident on Datix that involves a new interventional procedure 40 UCLH

5 1. Summary This policy sets out the mandatory requirements with which all staff must comply if they wish to introduce a new interventional procedure to UCLH. Clinicians must ensure compliance with this policy including where appropriate retrospective applications for any existing interventional procedures which are not registered. This is to ensure patient safety. Any clinicians introducing new interventional procedures without appropriate permissions and review will be referred to their clinical director for consideration of this issue during their formal appraisal. It is noted that if a new interventional procedure is undertaken at UCLH, without the appropriate permissions and review, the process in section 16 should be followed and it must be reported as an incident on Datix and investigated (see Appendix G). The policy details individual responsibilities, the processes for local consultation, notification to the Quality and Safety Department and approval by the relevant UCLH governance committee. 2. Equality Impact Statement The authors of this policy have undertaken an Equality Impact Assessment (EIA) and have concluded that there is no negative impact on any of the protected equalities groups. The completed EIA form is available from the Policy Compliance Officer. 3. Introduction Innovation in clinical practice is at the centre of the world-class healthcare provided by UCLH. UCLH is committed to ensuring the highest standards of patient safety and care. It is equally committed to supporting its clinicians who wish to pioneer novel techniques or procedures, thereby guaranteeing continued innovation and the responsible introduction of new interventional procedures. In November 2003, the Department of Health published the Health Service Circular: The Interventional Procedures Programme working with the National Institute for Clinical Excellence to promote safe clinical innovation (HSC 2003/011). That document detailed the procedure that must be followed by all medical practitioners planning to undertake a new interventional procedure and all NHS Chief Executives were expected to implement the actions. This policy sets out the process to be followed by all clinicians at UCLH wishing to introduce an interventional procedure that is: new to UCLH or new to UCLH and for emergency or compassionate use for named patients or new to UCLH and pre-trial or a major modification to an existing interventional procedure or new site or new indication for an existing interventional procedure UCLH

6 4. Objectives Ensure patient safety and support clinicians in the process of introducing a new interventional procedure. Establish a system that identifies any risk of non-compliance with this process. Enable UCLH to demonstrate how it takes into account and complies with the Health Service Circular and the NICE Interventional Procedures Programme. Ensure and enable UCLH to meet the relevant regulatory framework. 5. Scope This policy applies to all clinical staff undertaking interventional procedures across UCLH and covers: new interventional procedures major modifications to an existing interventional procedure (see section 10) new site or new indication for an existing interventional procedure (see section 11) emergency or compassionate use of a new interventional procedure for named patients (see section 12) pre-trial new interventional procedures (see section 13) Exclusions: This policy does not apply to: interventional procedures that are being used only within a protocol approved by the Research Governance Committee minor modifications to an existing interventional procedure (see section 10) introduction of new drug, human tissue related, or non-interventional treatments training of a UCLH health professional in an interventional procedure that is not new to UCLH, including extension of nursing or allied health professional roles. use of a new device to conduct an existing interventional procedure provided this does not lead to a major modification in the procedure. trial of new medical devices (see also section 15). 6. Definitions and acronyms Interventional Procedure (IP) A procedure used for diagnosis or for treatment that involves: o making a cut or a 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, or o 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 UCLH

7 inside of the stomach using an instrument inserted via the mouth, or o using electromagnetic radiation (which includes X-rays, lasers, gamma-rays and ultraviolet light) - for example, using a laser to treat eye problems. Definition provided by NICE New Interventional Procedure Modification of an Interventional Procedure Clinical Audit CE Mark Clinician Clinical Lead / Lead Clinician Effectiveness (clinical) Efficacy Indication IPG An interventional procedure new to the clinician in his or her NHS clinical practice, new to UCLH, or an existing interventional procedure being applied to a different part of the body or for a different indication. This may be extended to include any new interventional procedure which requires the attendance of an external person at the first use(s) of the intervention. Examples might include a company representative, application specialist, a visiting surgeon or a proctor. See section 10. The evaluation of clinical performance against standards or through comparative analysis, aimed at informing service management. Definition provided by NICE A CE Mark indicates that the manufacturer of a medical device complies with the relevant European Union Directive on safety, quality and performance. Definition provided by NICE A healthcare provider working in a clinic or hospital. The lead clinician applying to undertake the new interventional procedure. An effective procedure is one that, compared with other interventions, produces benefits that patients value in routine use. To be considered effective, the procedure must have been assessed in more standard clinical settings than is the case for efficacy. Definition provided by NICE An efficacious procedure is one that produces a desirable outcome in research conditions. Definition provided by NICE A condition or disease that may make a patient eligible for a particular treatment or procedure. Definition provided by NICE Guidance on the use of an interventional procedure based on current evidence of its safety and efficacy, issued by NICE. Definition provided by NICE UCLH

8 NICE CESG DCD DM MD QSC PIL Divisional PIL lead Patient Information Readership Panel RCT The National Institute for Health and Care Excellence Clinical Effectiveness Steering Group Divisional Clinical Director Divisional Manager Medical Director for one of UCLH s Clinical Boards Quality and Safety Committee Patient Information Leaflet A lead appointed by the division to oversee the functions of the local/divisional clinical governance/quality and safety committee s patient information group in line with the UCLH procedure for producing patient information which is available on Insight. Please refer to Insight for the list of local/divisional PIL leads. Appointed by local/divisional clinical governance/quality and safety committees to undertake the review and approval of PILs in line with the UCLH procedure for producing patient information. The panel should include patient representation. For further information, please refer to Insight for the UCLH procedure for producing patient information. Randomised controlled trial. A comparative study in which patients are allocated randomly to intervention and control groups, and are followed up to examine differences in outcomes between the groups. Definition provided by NICE 7. Duties and Responsibilities 7.1 Lead Clinician The lead clinician for the new interventional procedure is responsible for: o ensuring compliance with this policy o reviewing the safety and efficacy data with their DCD and obtaining approval to proceed. o discussing the financial impact with their Divisional Manager (DM) and obtaining funding approval. o drafting a PIL (see the UCLH Procedure for Producing Patient Information for the standard to be met and sections 8.3, and 13.6). o deciding plans for clinical audit. o obtaining approval from the MD of their Clinical Board. o verifying whether NICE has published guidance for this interventional procedure, and if not, registering via its website (see section 8.2). UCLH

9 o ensuring NICE guidance will be followed and should a decision be taken to diverge from NICE guidance that the process described in section is followed. o notifying the Clinical Effectiveness Coordinator and supplying a completed and signed application form (Appendix A or Appendix D). o presenting the application to the CESG. o presenting audit and patient outcomes data to the CESG in line with CESG s decision which is usually once the procedure has been in use for 12 months or after sufficient number of patients have undergone the procedure to enable adequate data. o once the CESG has agreed the interventional procedure is no longer considered new and may now be considered as being established at UCLH, the lead clinician will need to help facilitate their local / divisional governance / quality and safety group approvals for any additional clinicians (i.e. clinicians that were not listed on the original new interventional procedures application form) wishing to undertake the interventional procedure. o notifying the CESG in writing of any unexpected adverse clinical events or more than expected number of complications. o following the process detailed in section 16 and Appendix G in the case of retrospective applications. 7.2 Divisional Clinical Director (DCD) The DCD must discuss the proposed new interventional procedure with the lead clinician, and be assured of the safety and efficacy data, the clinical and cost effectiveness, any (non-)compliance with NICE guidance (see section ) and the impact on the division. The DCD must approve the new interventional procedure before it is submitted to the CESG. The signature of the DCD also indicates funding for the procedure has been approved. If a clinician has undertaken a new interventional procedure without the appropriate permissions and review, the DCD will need to consider this issue during the clinician s formal appraisal if appropriate. 7.3 Medical Director (MD) The MD is responsible for final approval of the proposed new interventional procedure application and his/her signature must be on the application submitted to the CESG. Occasionally, in accordance with the Director Level Clinical Decision agreement, he/she may be required to take an executive decision on approval of a new interventional procedure on urgent or compassionate grounds for a named patient. (See section 12). UCLH

10 7.4 Clinical Effectiveness Steering Group (CESG) The CESG is responsible for the decision regarding final approval of the introduction of all new interventional procedures at UCLH and reporting these to the Quality and Safety Committee (QSC). CESG is responsible for receiving initial details of patient outcomes and agreeing if the new interventional procedure may be considered established, or should remain new. CESG is also responsible for ensuring appeals against decisions not to approve are addressed through the proper channels (see Appendix B). 7.5 CESG Chair The Chair of the CESG is responsible for discussion and approval process of new interventional procedures. 7.6 Divisional Managers/Leads Divisional managers, theatre managers, senior nurses and other leads are responsible for raising any queries or issues with the Clinical Effectiveness Coordinator about whether a new interventional procedure within their area of practice has been approved or not. 7.7 Clinical Effectiveness Coordinator The Clinical Effectiveness Coordinator is responsible for: o guiding and supporting lead clinicians through the approval process. o checking the proposed use of the procedure is consistent with NICE guidance where this exists. o liaising with the CESG member representing the Medical Physics and Biomedical Engineering Department to identify any medical devices related requirements prior to the application being presented to CESG. o notification to the CESG and ensuring all the necessary documentation is in place and stored electronically on the Quality and Safety Department s shared drive. o managing the Quality and Safety Department s register of all new interventional procedure queries and applications. o notifying relevant staff members of CESG decisions. o including CESG decisions in the quarterly CESG reports to the QSC. o following the process detailed in section 16 and Appendix G in the case of retrospective applications. 7.8 Local governance group (also known as divisional quality and safety group) Patient information leaflets: o The local governance group appoints the patient information readership panel to undertake the review and approval of patient information leaflets in line with the UCLH procedure for producing patient information. The UCLH

11 panel should include patient representation. A divisional patient information lead is appointed by the division to oversee these functions of the local governance group. NICE guidance: o Where there is no NICE guidance for a proposed new interventional procedure or where the new interventional procedure would diverge from NICE guidance, it may be beneficial for the clinical lead to discuss their new interventional procedure application with the local governance group prior to submitting the new interventional procedure application to the DCD and MD and onward to CESG. Clinicians undertaking new interventional procedures: o Once the CESG has agreed the interventional procedure is no longer considered new, and may now be considered as being established at UCLH: the local governance group may approve additional clinicians (i.e. clinicians that were not listed on the original new interventional procedures application form) to undertake the interventional procedure. The lead clinician for the interventional procedure may help facilitate this approval process. ongoing monitoring of the outcomes data for the interventional procedure becomes the responsibility of the local governance group. Modifications to existing procedures and implants: o The local governance group may discuss (with the clinical lead and the clinical team) whether a modification to an existing interventional procedure would need to be considered as a major or a minor modification. Advice may always be obtained from the CESG Chair and/or the Clinical Effectiveness Coordinator. Major modifications constitute a new interventional procedure and approval must be sought from the CESG. Minor modifications may be introduced with the approval of the local governance group. 8. Introduction of new interventional procedures to UCLH Approval of the introduction of new interventional procedures is the responsibility of the CESG, on behalf of the Quality and Safety Committee (QSC) and the Chief Executive. Clinicians wishing to introduce a new interventional procedure to UCLH that they have not performed before or have only performed outside of UCLH and/or the NHS must comply with the procedure described below. Applications without the correct supporting papers and signatures will not be considered. UCLH

12 This process is summarised in the flowcharts in Appendix C1 and C Process of application to the Clinical Effectiveness Steering Group Discuss the proposal with the DCD, who must be satisfied that the new interventional procedure is safe or safer, likely to give patient benefit, an equal or better use of resources than existing treatment and that it will either be funded by the division or appropriate funding has been identified Discuss with the DM and the DCD the possible impact (e.g. staff training needs) and cost implications to the division Agree plans to audit outcomes Write a PIL. The style, content and approval of the PIL must comply with UCLH policy for producing patient information. See section Notify the Clinical Effectiveness Coordinator and complete the application form to the CESG: Application to Introduce a New Interventional Procedure The form includes guidance and may be found in Appendix A and on Insight in both the policies webpage and on the interventional procedure page of the clinical effectiveness Insight webpage. The application form must be signed by both DCD and the MD of the relevant Clinical Board. The signatures indicate funding has been approved or external funding identified. The application form must be accompanied by the PIL (see section 8.3), copy of existing NICE guidance, key references and any other relevant supporting information, for example training records as well as a presentation to CESG. All application paperwork must be submitted two weeks prior to the CESG meeting to enable review by CESG members. 8.2 NICE Interventional Procedure Guidance Verify if NICE has published interventional procedure guidance (IPG) for this procedure (see Appendix F). If not, the clinician must register it with NICE via its website at: NICE will assign a reference number and this must be recorded on the new interventional procedure application form The clinician must provide assurance to the division and to CESG that if a NICE IPG has been published, the proposed new interventional procedure will be undertaken in compliance with that guidance NICE organize their IPGs into categories, depending on the arrangements required for their use. UCLH

13 Should a division wish to proceed with a new interventional procedure application for a procedure that NICE has specified should only be undertaken in the context of research, a divergence from the NICE guidance must be clearly described on the application form. In line with section 6.2 of the UCLH NICE policy, the DCD / divisional management team take responsibility for and oversee any divisional decision not to comply with NICE guidance or divergence from the guidance. By signing the new interventional procedure application form, the DCD and MD are signing-off the divergence. Patient selection needs to be clearly demonstrated on the application paperwork and presentation to CESG and could include e.g. a flowchart of the patient selection process and multi-disciplinary team thought process involved. There are often interventional procedures which are so new or novel that NICE has not yet reviewed the interventional procedure. CESG considers these new interventional procedure applications and CESG approval would be subject to interventional procedure registration with NICE (see section 8.2.2). By signing the new interventional procedure application form the lead clinician, DCD and MD are assuring the Chief Executive that they have reviewed the safety and efficacy of the new interventional procedure and are satisfied that it is as safe or safer, likely to give patient benefit and an equal or better use of resources than existing treatment and that funding has been approved or identified. Where there is no NICE guidance for a new interventional procedure or where the new interventional procedure would diverge from NICE guidance it may be beneficial for the clinical lead to discuss the new interventional procedure application with the local clinical governance group prior to submitting the application to the DCD and MD and onward to CESG NICE assessment of the safety and efficacy of an interventional procedure may conclude the procedure should not be used in the NHS. These are do not use recommendations and CESG will not consider applications to introduce any such procedures. 8.3 Patient Information Before the new interventional procedure can be approved a patient information leaflet (PIL) must be drafted (supported by the divisional patient information lead) and submitted to the CESG together with the new interventional procedure application paperwork. The CESG will not consider the new interventional procedure unless an adequate UCLH

14 draft PIL accompanies the application. The PIL will need to be approved by the divisional patient information readership panel. For further information, please refer to the UCLH procedure for producing patient information which can be accessed via Insight The PIL must comply with UCLH Procedure for Producing Patient Information and be drafted on one of the UCLH branded templates. All staff producing UCLH patient information materials should contact their divisional patient information lead first who will be able to advise further on the process. The templates and further information on the process is available on the Insight patient information webpage The PIL must state the interventional procedure is new to UCLH and include information about the special status of the interventional procedure and the lack of experience of its use at UCLH. Patients must be informed that this is a new procedure so safety and efficacy is uncertain and they must be informed about the anticipated benefits and possible adverse effects of the procedure and alternatives, including no treatment If NICE has produced patient information for the interventional procedure, this may be used but must be put into the UCLH format or supplemented with a UCLH PIL. 8.4 Approval Process The Clinical Effectiveness Coordinator will acknowledge the new interventional procedure application, and log the interventional procedure on the register held in the Quality and Safety Department and guide the applicant through the approval process. See section The clinical lead is required to present the application in person. A delegate may be sent, but the delegate should be confident to discuss issues such as clinical effectiveness and safety The CESG will review details of the application, specifically: o that the applicant has met external standards of training. o that there has been adequate consideration of training of UCLH staff. o the clinical effectiveness and safety of the procedure. o that the applicant has received funding approval from the division. o that the PIL is compliant with UCLH policy and informs the patient of the newness of the interventional procedure. o that there are sound arrangements for clinical audit that will capture patient outcomes data. o that if NICE guidance has been published, the proposed use of the interventional procedure complies with that guidance and if not, that the divergence has been clearly detailed in the new IP application form signed by the clinical lead, DCD and MD. UCLH

15 o that the division has considered and approved the above During the meeting, members may question the applicant and the applicant may add any information they consider pertinent A decision will be reached during the CESG meeting and in the presence of the applicant in the majority of cases. Unless specified on the application form, approval is for use by the clinical lead only. Approval for other members of the team to undertake the procedure at a later date should be given by the divisional governance committee once they are satisfied with evidence of training and competency and this decision should be noted or recorded After the CESG meeting, the Clinical Effectiveness Coordinator will notify relevant staff members of the CESG decisions. This will include notifying the applicant/clinical lead and the Divisional Senior Nurse, MD, DCD, DM, Divisional General Manager(s), Divisional Matron(s), UCLH Patient Information Lead, CESG member representing the Medical Physics and Biomedical Engineering Department as well as the Theatres and Anaesthesia Division s DCD, DM, GM, Matron, Service Manager(s) and relevant theatre lead(s). 8.5 Appeal against CESG decision Clinicians may appeal against the decision of the CESG, should their application be turned down. See Appendix B. 8.6 Expired applications It is expected the new interventional procedure will be introduced within two years of the decision to approve. This expectation is based on the correct process having been followed in that funding will already have been identified prior to application to CESG If the procedure has not been introduced within two years following CESG approval, a new application is required. This ensures that clinical effectiveness issues such as risk, benefit, NICE recommendations, impact and published data are up to date A modified application form is available from the Clinical Effectiveness Coordinator. 9. Post-approval assurances 9.1 Outcomes If the interventional procedure is approved, the clinical lead is asked to return to the CESG on an agreed date to present details of patient outcomes. This enables assessment of the procedure s safety and effectiveness. The CESG will then decide whether the procedure should remain a new procedure or whether this classification may be removed and it may now be considered established in which case, ongoing monitoring becomes the responsibility of the local/divisional governance group. UCLH

16 9.1.1 Should outcome data not be supplied one year following request, CESG will consider removing approval for the procedure to continue on grounds of lack of assurance of its safety and effectiveness. 9.2 Action monitoring The Clinical Effectiveness Coordinator keeps a record of all applications to the CESG, their actions and status. These are regularly followed up and scrutinised by the CESG. 9.3 Adverse events and complications Should there be any unexpected adverse clinical events or more than expected number of complications, the clinical lead should notify CESG in writing, suggesting a course of action. Based on the information supplied by the clinical lead, CESG will discuss and agree an appropriate course of action, referring back to the divisional governance committee if necessary. 10. Modifications to existing procedures and implants 10.1 Existing procedures and implants are often modified. These modifications should be discussed within the clinical team and by the local governance committee to enable a decision on whether the modification is significant / major or a minor one Significant or major modifications constitute a new interventional procedure and approval must be sought from the CESG. As a guide, a significant modification is one whereby the information given to the patient during the consent process requires amending Minor modifications may be introduced with the approval of the local governance group Advice may always be obtained from the CESG Chair and the Quality and Safety team. 11. New site and/or indication of existing interventional procedure 11.1 Approval will only cover use of the interventional procedure for the site on the body at which the original application was made. Use at a new site must first be approved by the CESG Use of an existing procedure but for a new indication must be approved by the CESG. UCLH

17 12. Emergency or compassionate use of a new interventional procedure for named patients 12.1 If a clinician proposes an interventional procedure which is new to UCLH, has not been through the CESG approval process and the procedure is for emergency or compassionate use for a named patient, the clinician will need to: a) ensure that all in the clinical team or speciality group i.e. not a single individual, however senior, are in agreement and have signed a letter which is filed in the patient s case notes. b) ensure that the above-mentioned letter: i) describes the proposed procedure and clarifies the clinical need for this particular patient. ii) explains that the proposed procedure is the only option available to the patient. iii) explains why undertaking the proposed procedure is the right thing to do for the patient i.e. the procedure is justifiable in the circumstances and there is evidence to support it. iv) confirms that the patient consent process will include the risks, benefits and alternatives and that the proposed procedure is new to UCLH The clinician should submit the letter mentioned above in section 12.1 to the Clinical Effectiveness Coordinator who will liaise with the CESG Chair and request approval from the DCD followed by a request for approval from the MD of the relevant Clinical Board and the MD for Corporate Services. If either the MD of the relevant Clinical Board or the MD for Corporate Services are not available, then another MD may approve in their place. Any decision should be made by at least two of the MDs. The MDs will take an executive decision about appropriateness and risk to the patient and UCLH. This is a Director Level Clinical Decision. Where applicable, approval should also be obtained from the Chief Nurse. All communications, including approval, must be in writing. This will serve to provide robust evidence that due process has been followed. s and a scanned copy of the letter mentioned in section 12.1 above are acceptable forms of written evidence. The Clinical Effectiveness Coordinator will keep a record of all requests and decisions If the clinician receives approval (as described in section 12.2) outcomes data must be submitted to the CESG via the Clinical Effectiveness Coordinator Should the clinician wish to either introduce the new interventional procedure into routine use or conduct a clinical trial, he/she must then make an application to either the CESG (via the Clinical Effectiveness Coordinator) or to the Research Governance Committee, as appropriate. UCLH

18 Applications must be made before any further use of the procedure, whether routinely or under trial conditions. 13. Pre-trial new interventional procedures This process is summarised in the flowcharts in Appendix E1 and E The clinical lead(s) for this pre-trial new interventional procedure should, if possible, try carry out the first cases within the trial so the whole process is done under the cover of the clinical trial regulations. i.e. the cases are only done as part of the trial, but the first few cases are proctored to ensure that the operator is competent to undertake the intervention needed for the trial and the company producing the device provides training and proctorship for this. The Clinical Effectiveness Coordinator will liaise with the Joint Research Office (JRO). The JRO may assist in: checking the trial is registered with the JRO and assigned a REDA number; liaising with the clinical lead and e.g. sponsors to encourage the first cases being done as part of the trial; providing the details on the trial including the protocol, title of the trial, training and whether devices are CE marked If it is not possible to perform the first procedures within the trial, the CESG could consider the application for a set number of cases (maximum of 10 cases) prior to the trial. This must be supervised by a proctor and the proctor may need an honorary contract if they are not on the staff of UCLH. The clinical lead will need to contact the Human Resources department to arrange this. The clinical lead must present the application paperwork to the CESG. The CESG would not be able to assess the effectiveness of these pre-trial procedures however the perceived safety of the procedure must be assessed. The JRO may assist in providing information on the safety of the procedure The clinical lead will need to provide the following application paperwork to CESG: A draft patient information leaflet (PIL). Please see section 8.3 for the PIL requirements. In addition to section 8.3, PILs for pre-trial new interventional procedures must state that the procedure is new to UCLH and also that it is experimental in that there is no evidence of its effectiveness. Please see section 13.6 for action to be taken regarding PILs once the agreed number of pre-trial new interventional procedures has been undertaken Application form to introduce a pre-trial new interventional procedure completed and signed by the lead clinician. (See Appendix D) The form must be signed by both the Divisional Clinical Director and Medical Director of the relevant clinical board If NICE has not published interventional procedure guidance (IPG) for this procedure, the clinician must record on the application form the reference number NICE provides after the clinician has registered the interventional procedure with NICE via its website at UCLH

19 (See section 8.2) Should a division wish to proceed with a procedure that diverges from NICE guidance, the divergence must be clearly described on new interventional procedure application form which is then signed by the clinical lead, DCD and MD and later reviewed by the CESG. In line with UCLH s policy on NICE implementation and monitoring, the DCD/management team take responsibility for and oversee any divisional decision not to comply with (or to diverge from) NICE guidance. See section 6.2 of UCLH NICE policy Pre-trial new interventional procedure PowerPoint presentation (template available from the Clinical Effectiveness Coordinator) Key references addressing safety of the intervention and any other relevant supporting information e.g. training records/certificates The Clinical Effectiveness Coordinator will contact the Medical Physics and Biomedical Engineering Department and the JRO to request their assessment of the completed application form and for their notification of any further requirements Following CESG assessment and approval of the pre-trial new interventional procedure application paperwork, the division will be permitted to undertake the agreed number of pre-trial cases. The clinical lead is required to notify CESG in writing should there be any unexpected adverse clinical events or more than expected number of complications. After the CESG meeting, the Clinical Effectiveness Coordinator will notify relevant staff members of the CESG decisions. This will include notifying the applicant/clinical lead, the JRO, Divisional Senior Nurse, MD, DCD, DM, Divisional General Manager(s), Divisional Matron(s), UCLH Patient Information Lead, CESG member representing the Medical Physics and Biomedical Engineering Department as well as the Theatres and Anaesthesia Division s DCD, DM, GM, Matron, Service Manager(s) and relevant theatre lead(s) Once the agreed number of pre-trial new interventional procedures has been undertaken, the interventional procedure may only be continued within the trial. The clinical lead must ensure that the patient information leaflet is removed from circulation and that the outcomes data is presented to the CESG Once the trial has been completed and there is evidence of both safety and effectiveness of the pre-trial new interventional procedure, the clinical lead may return to the CESG with the standard application paperwork for introduction of a new interventional procedure to UCLH. UCLH

20 14. Research 14.1 NICE assessment of a new interventional procedure may conclude that there is inadequate evidence on its safety and efficacy and that it must therefore only be undertaken in the context of clinical research This does not mean that a research application is automatically approved; the standard Research and Development approval processes must be followed As mentioned in section , and in line with UCLH policy on NICE implementation and monitoring, the DCD/divisional management team take responsibility for and oversee any divisional decision not to comply with (or to diverge from) NICE guidance The Chair of the Research Ethics Committee should advise whether the procedure falls into the research category. 15. Medical Devices 15.1 Trial of a new medical device or modification of an established medical device does not fall under the remit of CESG unless this results in a significant modification of a procedure. Notification must be made to the Medical Devices Committee in accordance with UCLH policy A member of the Medical Devices Committee sits on CESG and will advise as required. 16. Retrospective applications for new interventional procedures It is noted that if a new interventional procedure (see definition in section 6) is undertaken at UCLH without the appropriate permissions and review as described in this policy, the following actions must be taken: 1. An incident must be reported on Datix and the circumstances which caused the new interventional procedure to be used without approval investigated. See Appendix G. 2. The UCLH Clinical Effectiveness Coordinator must be notified. 3. The Clinical Effectiveness Coordinator will notify the clinical lead, the relevant DCD and the CESG Chair that the new interventional procedure has not yet received the appropriate permissions and review and so its use is not currently supported by UCLH and the use must cease. Once the procedure has been presented to CESG and received CESG approval, the lead clinician may resume undertaking the procedure at UCLH. 4. The Clinical Effectiveness Coordinator will send the lead clinician a retrospective new interventional procedure application form, an outcomes data template, information on compiling a patient information leaflet (see section 8.3) and a CESG presentation template for the lead clinician to complete and return to the Clinical Effectiveness Coordinator. UCLH

21 5. The DCD must consider the issue during the lead clinician s formal appraisal if appropriate. 6. The Clinical Effectiveness Coordinator will notify the CESG of actions taken and this notification will be included in the CESG meeting minutes. 7. Once the Clinical Effectiveness Coordinator has received the above mentioned documentation, the lead clinician will then be asked to attend a CESG meeting where the application, outcomes data (for the cases already undertaken) and the patient information leaflet will be discussed and reviewed. 8. The CESG will make a decision on whether or not use of the new interventional procedure may resume. The Clinical Effectiveness Coordinator will send an notifying the clinical lead and relevant staff members (see Appendix F, section 3.6) of the CESG s decision. 9. If the CESG approves the continued use of the new interventional procedure, the clinical lead will be required to return to the CESG on an agreed date to present outcomes data. After having reviewed outcomes data, the CESG will make a decision on whether the new interventional procedure may be considered as an established procedure at UCLH. See section Monitoring and Audit See Appendix F for details of the governance framework and compliance assurances. What in the policy is going to be monitored? All new interventional procedures are introduced via the approval route described in this policy. Monitoring method Quarterly review of Datix incidents for items relating to new interventional procedures in order to identify those undertaken without appropriate permissions. Seek assurance from theatre leads and managers that theatre lists are assessed to identify new interventional procedures which have not received appropriate permissions. Who will lead the monitoring? Clinical Effectiveness Coordinator, Quality and Safety Department How often? Quarterly Where will it be reported? CESG UCLH

22 Raising awareness of the policy Annual reminders of the process for notification of new interventional procedures sent via by the Corporate Medical Director to Theatre Leads, Divisional Senior Nurses and Divisional Managers Clinical Effectiveness Coordinator, Quality and Safety Department Annually CESG Corporate Medical Director gathers assurances from all Divisional Clinical Directors that the policy has been followed in their division over the previous 12 months 18. Reference The Interventional Procedures Programme working with the National Institute for Clinical Excellence to promote safe clinical innovation (HSC 2003/011) UCLH

23 Appendix A APPLICATION TO INTRODUCE A NEW INTERVENTIONAL PROCEDURE (vjun-18) Prior to submission, your proposal must be discussed with your Divisional Clinical Director who, with the Medical Director, must sign this form. This application form should not be used for pre-trial new interventional procedures. SECTION 1: APPLICANT DETAILS 1.1 Clinician Name and title (block capitals) 1.2 Department / Specialty 1.3 Division and Clinical Board 1.4 Are you a consultant or other independent practising clinician? YES NO - If you are a Trainee under supervision of a named trainer, this form does not apply to you. Your performance of interventional procedures should be monitored and supervised as part of your recognised training pathway within UCLH. SECTION 2: INTERVENTIONAL PROCEDURE DETAILS 2.1 Title of interventional procedure 2.2 Description of proposed use of the interventional procedure 2.3 Anticipated implementation date 2.4 Name and title of clinician(s) who it is intended will undertake the procedure CESG approval will only be granted for clinicians who are listed in this section 2.4 to undertake the new interventional procedure. Once CESG has confirmed that the new interventional procedure is an established procedure and no longer considered new, the local governance group may then approve additional clinicians (i.e. clinicians that are not listed in this section 2.4) to undertake the interventional procedure Does the lead clinician(s), divisional clinical director, medical director or clinician(s) who intend to undertake the procedure have a conflict of interest e.g. have been paid by, or receive support from, the company? UCLH

24 YES NO If yes, please also declare the conflict of interest by completing and submitting the form on the UCLH Insight page: m/,danainfo=insight+allitems.aspx 2.5 State reason(s) for implementing this interventional procedure, including anticipated benefits for patients 2.6 Does new interventional procedure involve medical devices or equipment? Yes / No If No - go to Section 3 If Yes: Provide a description of the device/equipment including the manufacturer and model: Is the equipment CE Marked as a Medical Device? Yes / No Is the equipment new to UCLH? Yes / No Has the equipment been purchased or is it on-loan to UCLH? Purchased / On-Loan Has training on the equipment been received by the clinician(s) who will undertake the procedure? Yes / No For reusable/multi-use equipment has it undergone acceptance in Clinical Engineering? Yes / No If Yes provide a device ID or job number: For any queries, please contact the Medical Equipment Helpdesk on extension or mpb.helpdesk@uclh.nhs.uk or visit their Insight webpage. SECTION 3: NICE (see notes 1-4 below) 3.1 Is the procedure listed on the NICE website? YES NO If yes go to 3.2 If no go to YES If guidance has been issued to support the interventional procedure, will UCLH practice be compliant with the NICE interventional procedure guidance? 3.3 NO COMPLIANT NOT COMPLIANT Details of the non-compliance or divergence: Notify the procedure to NICE via the website and record the reference number below UCLH

25 procedures-guidance/ip-notification-form NICE IP reference number: Complete section 4 and 5 of this form and discuss and agree how to proceed with your Divisional Clinical Director. The Chief Executive will be informed through the Clinical Effectiveness Steering Group. Note 1 The search function on the NICE website via the above link will inform whether guidance has been issued, guidance is in progress, complete, or the procedure is not in the NICE remit. Many procedures will be on the list but guidance will be pending. You should discuss with your DCD how to proceed while awaiting NICE guidance. Note 2 Guidance issued by NICE may specify issues relating to consent, training, facilities, research or audit that need to be addressed. You must notify your Divisional Clinical Director of these. SECTION 4: SAFETY AND EFFICACY 4.1 Applicants must meet standards set in guidance from the relevant Professional Body/Royal College. Outline how you will ensure you are appropriately trained: 4.2 Have you reviewed the safety and efficacy data on this procedure with your Divisional Clinical Director and are satisfied that it is safe or safer, likely to give patient benefit and an equal or better use of resources then existing treatment? YES NO Key references: Level of evidence supplied - please indicate: Ia: systematic review or meta-analysis of RCTs Ib: at least one RCT IIa: at least one well-designed controlled study without randomisation IIb: at least one well-designed quasi-experimental study, such as a cohort study III: well-designed non-experimental descriptive studies, such as comparative studies, correlation studies, case-control studies and case series IV: expert committee reports, opinions and/or clinical experience of respected authorities 4.3 Risks Please list any serious or frequently occurring risks: Are there any other specific risks associated with this procedure? For example positional damage or cardiorespiratory risks. YES NO UCLH

26 Details: Applicants should be aware of the need to mitigate any risk of tissue or nerve damage due to patient positioning, for example, rhabdomyolosis, pressure ulcer, brachial plexus injury 4.4 Provision of a patient information leaflet (PIL) is mandatory. A PIL must be developed by the lead clinician with assistance from the divisional patient information lead. The PIL must be approved by the divisional patient information readership panel before the new interventional procedure is undertaken. The PIL for this new interventional procedure must state that the procedure is new to UCLH. Outline how you will fully inform patients about the possible benefits, risks and alternative treatments for this procedure: 4.5 Provision of outcome data to CESG is required once sufficient cases have been undertaken. Outline plans to audit patient outcomes of this new interventional procedure: 5. ASSESSMENT OF IMPACT ON UCLH 5.1 Procedure that will be replaced? 5.2 Possible impact on your Division? Cost implications must be considered and any possible impact discussed with your Divisional Manager 5.3 Possible impact on other clinical services/divisions within the UCLH? For example, Radiology, Pathology, ICU, Transport etc. Discuss with the relevant Divisional Manager 5.4 Implications for the training of other staff? Discuss with the relevant Divisional Manager Do any other staff groups require training to assist with this procedure? 5.5 Possible impact on other health services? For example, Primary Care 6. AUTHORISATION SIGNATURES By signing you are assuring the Chief Executive that you have reviewed the safety and efficacy of this interventional procedure and are satisfied that it is as safe or safer, likely to give patient benefit and an equal or better use of resources than existing treatment. The signature of the DCD indicates that funding has been approved or identified. Lead Clinician(s) for the procedure Name. Title UCLH

27 Signature. Date.. Divisional Clinical Director* Name.. Title. Signature Date.. Medical Director** Name Title.. Signature Date.. Signed application forms must be sent to the Clinical Effectiveness Coordinator, Quality and Safety Department, 2 nd Floor West, 250 Euston Road). A scanned copy is acceptable, to angela.schulze@nhs.net Every application is registered and monitored by the Clinical Effectiveness Steering Group. The Chief Executive is informed of new interventional procedures via the CESG report to the QSC. * If the Divisional Clinical Director wishes to introduce a new interventional procedure, the signature of another senior clinician, ideally the Clinical Governance Lead, should be provided. ** Signature of the Medical Director of the relevant Clinical Board is required. UCLH

28 Appendix B Appeals against the decision of the CESG Clinicians may appeal against the decision of the CESG should their application to introduce a new interventional procedure be turned down. Clinicians should appeal in writing to the Medical Director for Corporate Services, via the Chair of the CESG. All submitted evidence should have been considered by the CESG in accordance with this policy. New evidence will not be considered as this should be re-submitted to the CESG as a new application. The grounds for appeal must be specified as follows: 1. The CESG assessment of the comparative effectiveness of the interventional procedure is incorrect. 2. The CESG assessment of the comparative safety of the interventional procedure is incorrect. 3. The CESG assessment of the comparative convenience of the interventional procedure is incorrect. 4. The health economic assessment is incorrect. 5. The CESG decision puts the services of UCLH at a disadvantage with respect to its competitors. The papers supporting the original application and the minutes of the meeting at which the application was discussed must be made available for the Corporate Medical Director to scrutinise. Appeals should be made within 21 days of receipt of the notification from the Clinical Effectiveness Coordinator of the CESG outcome. The decision of the Corporate Medical Director is final and will be communicated to both the clinician and the Chair of the CESG in writing. UCLH

29 Appendix C1: New interventional procedure application process flowchart UCLH

30 Appendix C2: New interventional procedure approval process flowchart UCLH

31 Appendix D Application to introduce a Pre-Trial New Interventional Procedure (vjun-18) Prior to submission, your proposal must be discussed with your Divisional Clinical Director who, with the Medical Director, must sign this form. Please read the following before continuing with this application. The clinical lead(s) for this new pre-trial interventional procedure should if possible, try carry out the first cases within the trial so the whole process is done under the cover of the clinical trial regulations. i.e. the cases are only done as part of the trial, but the first few cases are proctored to ensure that the operator is competent to undertake the intervention needed for the trial and the company producing the device provides training and proctorship for this. If this is not possible, the CESG will consider the application for a set number of cases (maximum of 10) prior to the trial, this must be supervised by a proctor and the proctor will need an honorary contract if they are not on the staff of UCLH. The clinical lead will need to contact the Human Resources department to arrange this. The clinical lead must present the application paperwork to the CESG. The CESG would not be able to assess the effectiveness of these pre-trial procedures, however the perceived safety of the procedure must be assessed. The clinical lead will need to provide the following application paperwork to CESG: 1. A draft patient information leaflet (PIL). The divisional patient information lead may assist in this process. The PIL must state that the procedure is not only new to UCLH, but that it is also experimental in that there is no evidence of its effectiveness. 2. Application form to introduce a pre-trial new interventional procedure completed and signed by the lead clinician. The form must be signed by both the Divisional Clinical Director and Medical Director of the relevant clinical board. 3. If NICE has not published interventional procedure guidance (IPG) for this procedure, the clinician must record on the application form the reference number NICE provides after the clinician as registered the interventional procedure with NICE. 4. Pre-trial new interventional procedure PowerPoint presentation. 5. Key references addressing safety of the intervention and any other relevant supporting information e.g. training records/certificates Following CESG assessment and approval of the pre-trial new interventional procedure application paperwork, the division will be permitted to undertake the agreed number of pre-trial cases. Once the agreed number of procedures has been undertaken, the procedure can only be continued within the trial. Once the trial has been completed and there is evidence of both safety and effectiveness of the new interventional procedure, the clinical lead is welcome to return to the CESG with the standard application paperwork for introduction of a new interventional procedure to UCLH. UCLH

32 Section 1: Applicant Details 1.1 Clinician Name and title (block capitals) 1.2 Department / Specialty 1.3 Division and Clinical Board 1.4 Are you a consultant or other independent practising clinician? Yes No If you are a trainee under supervision of a named trainer, this form does not apply to you. Your performance of interventional procedures should be monitored and supervised as part of your recognised training pathway within UCLH. Section 2: Pre-Trial New Interventional Procedure Details 2.1 Title of pre-trial new interventional procedure 2.2 Description of proposed use of the pre-trial new interventional procedure UCLH

33 2.3 Anticipated implementation date 2.4 Name and title of clinician(s) who it is intended will undertake the pre-trial new interventional procedure CESG approval will only be granted for clinicians who are listed in this section 2.4 to undertake the new interventional procedure. Once CESG has confirmed that the new interventional procedure is an established procedure and no longer considered new, the local governance group may then approve additional clinicians (i.e. clinicians that are not listed in this section 2.4) to undertake the interventional procedure Does the lead clinician(s), divisional clinical director, medical director or clinician(s) who intend to undertake the procedure have a conflict of interest e.g. have been paid by, or receive support from, the company? Yes No If yes, please declare the conflict of interest by completing and submitting the form on the UCLH Insight page: orm/,danainfo=insight+allitems.aspx 2.5 State reason(s) for implementing this pre-trial new interventional procedure, including anticipated benefits for patients 2.6 Does the pre-trial new interventional procedure involve medical devices or equipment? Yes No If Yes, complete to If No, continue with section Provide a description of the device/equipment including the manufacturer and model: Is the equipment CE Marked as a Medical Device? Yes No Is the equipment new to UCLH? Yes No Has the equipment been purchased or is it on-loan to UCLH? Purchased On-Loan UCLH

34 2.6.5 Has training on the equipment been received by the clinician(s) who will undertake the procedure? Yes No For reusable/multi-use equipment has it undergone acceptance in Clinical Engineering? Yes No If Yes, provide a device ID or job number: For any queries, please contact the Medical Equipment Helpdesk on extension or mpb.helpdesk@uclh.nhs.uk Section 3: NICE 3.1 Is the procedure listed on the NICE website? Yes No If Yes, complete 3.2 If No, complete 3.3 The search function on the NICE website via the above link will inform whether guidance has been issued, guidance is in progress, complete, or the procedure is not in the NICE remit. Many procedures will be on the list but guidance will be pending. You should discuss with your DCD how to proceed while awaiting NICE guidance. Guidance issued by NICE may specify issues relating to consent, training, facilities, research or audit that need to be addressed. You must notify your Divisional Clinical Director of these. 3.2 If guidance has been issued to support the interventional procedure, will UCLH practice be compliant with the NICE interventional procedure guidance? Compliant 3.3 Notify the procedure to NICE via the website Programmes/NICE-guidance/NICE-interventionalprocedures-guidance/IP-notification-form Discuss and agree how to proceed with your Divisional Clinical Director Provide the NICE IP reference number: Not compliant Details of non-compliance: Section 4: Safety and Effectiveness 4.1 Applicants must meet standards set in guidance from the relevant Professional Body/Royal College. Outline how you will ensure you are appropriately trained: Outline how you will be supervised by a proctor: UCLH

35 Note: the proctor will need an honorary contract if they are not on the staff of UCLH and the clinical lead is responsible for contacting the Human Resources department in this regard). 4.2 Have you reviewed the safety and efficacy data on this procedure with your Divisional Clinical Director and are you satisfied that it is safe or safer, likely to give patient benefit and an equal or better use of resources then existing treatment? Yes No Key references: Level of evidence supplied - please indicate: Systematic review or meta-analysis of RCTs At least one RCT At least one well-designed controlled study without randomisation At least one well-designed quasi-experimental study, such as a cohort study Well-designed non-experimental descriptive studies, such as comparative studies, correlation studies, casecontrol studies and case series Expert committee reports, opinions and/or clinical experience of respected authorities 4.3 Risks Please list any serious or frequently occurring risks: Are there any other specific risks associated with this procedure? For example positional damage or cardiorespiratory risks. Yes No Details: Applicants should be aware of the need to mitigate any risk of tissue or nerve damage due to patient positioning, for example, rhabdomyolosis, pressure ulcer, brachial plexus injury UCLH

36 4.4 Provision of a patient information leaflet is mandatory. A Patient information leaflet (PIL) must be developed by the lead clinician with assistance from the divisional patient information lead. The PIL must be approved by the divisional patient information readership panel before the pre-trial new interventional procedure is undertaken. The PIL for this pre-trial new interventional procedure must state that the procedure is new to UCLH and that it is also experimental in that there is no evidence of safety or effectiveness. Outline how you will fully inform patients about the possible benefits, risks and alternative treatments for this procedure: 4.5 Provision of outcome data to CESG is required once sufficient cases have been undertaken. Outline plans to audit patient outcomes of this pre-trial new interventional procedure: Section 5: Assessment of impact on UCLH 5.1 Procedure that will be replaced? 5.2 Possible impact on your Division? Cost implications must be considered and any possible impact discussed with your Divisional Manager. 5.3 Possible impact on other clinical services or divisions within UCLH? For example, Radiology, Pathology, ICU, Transport etc. Discuss with the relevant Divisional Manager. 5.4 Implications for the training of other staff? Discuss with the relevant Divisional Manager Do any other staff groups require training to assist with this procedure? 5.5 Possible impact on other health services? For example, Primary Care UCLH

37 Signatures are required on the next page Section 6: Authorisation signatures By signing you are assuring the Chief Executive that you have reviewed the safety and efficacy of this interventional procedure and are satisfied that it is as safe or safer, likely to give patient benefit and an equal or better use of resources than existing treatment. The signature of the DCD indicates that funding has been approved or identified. Lead Clinician(s) for the procedure Name(s). Title(s) Signature(s). Date.. Divisional Clinical Director* Name.. Title. Signature Date.. If the Divisional Clinical Director wishes to introduce a new interventional procedure, the signature of another senior clinician, ideally the Clinical Governance Lead, should be provided. Medical Director** Name Title.. Signature Date.. Signature of the Medical Director of the relevant Clinical Board is required. Signed application forms must be sent to the Clinical Effectiveness Coordinator (Quality and Safety Department, 2 nd Floor West, 250 Euston Road). A scanned copy is acceptable and should be ed to angela.schulze@nhs.net. Every application is registered and monitored by the Clinical Effectiveness Steering Group. UCLH

38 The Chief Executive is informed of new interventional procedures via the CESG report to the QSC. * If the Divisional Clinical Director wishes to introduce a new interventional procedure, the signature of another senior clinician, ideally the Clinical Governance Lead, should be provided. ** Signature of the Medical Director of the relevant Clinical Board is required. UCLH

39 Appendix E1: Pre-trial new interventional procedure application process flowchart UCLH

40 Appendix E2: Pre-trial new interventional procedure approval process flowchart UCLH

41 Appendix F Governance Framework and Policy Assurance 1. NICE Interventional Procedure Programme The National Institute for Health and Clinical Excellence (NICE) Interventional Procedures Programme assesses the safety and efficacy of new interventional procedures and subsequently produces guidance. Details of the NICE IPG programme may be found on the NICE website at: ventional_procedures.jsp The aim is to protect patient safety and support the NHS in the process of introducing new procedures. A complete list of all published interventional procedure guidance (IPG) may be found on their website: Clinicians wishing to introduce a new interventional procedure that has not yet been published or is not in development must notify NICE either via their notification form 2. Department of Health HSC 2003 / 011 The Health Service Circular 2003 / 011 states that clinical governance committees must take the NHS LA risk management standard into account when reviewing applications for use of new interventional procedures. See Appendix A. 3. Policy Compliance Assurance 3.1 UCLH has a range of actions in place to provide assurance of compliance:the Clinical Effectiveness Coordinator, the Chair of the CESG and the Medical Director for Corporate Services regularly raise awareness amongst clinicians about the process described in this policy. 3.2 Annual reminders of the process for notification of new interventional procedures are sent via by the Corporate Medical Director to Theatre Leads, Divisional Senior Nurses and Divisional Managers. 3.3 The Corporate Medical Director gathers assurances from all Divisional Clinical Directors that the policy has been followed in their division over the previous 12 months. 3.4 If it is found that a new interventional procedure has been undertaken without appropriate permissions and review, an incident will be reported on Datix and investigated. See section 16 and Appendix G. 3.5 The Clinical Effectiveness Coordinator will on a quarterly basis: i. review Datix incidents for new interventional procedures undertaken without appropriate permissions. UCLH

42 ii. seek assurance from the theatre leads and managers that theatre lists are assessed to identify new interventional procedures which have not received appropriate permissions. 3.6 Notifications of CESG decisions on new interventional procedure applications are sent by the Clinical Effectiveness Coordinator to the clinical lead, Divisional Senior Nurse, MD, DCD, DM, Divisional General Manager(s), Divisional Matron(s), UCLH Patient Information Lead, CESG member representing the Medical Physics and Biomedical Engineering Department as well as the Theatres and Anaesthesia Division s DCD, DM, GM, Matron, Service Manager(s) and relevant theatre lead(s). 3.7 Registration to the Research and Development directorate for research projects includes a question on whether the protocol includes a new interventional procedure. 3.8 The senior research administrator will notify the Clinical Effectiveness Coordinator of any protocols that include an interventional procedure. 3.9 Introduction of new interventional procedures is a standing item on the agenda of the CESG and a comprehensive database kept in the Quality and Safety Department CESG decisions on new interventional procedures are reported to the QSC via the CESG quarterly report to QSC. UCLH

43 Appendix G How to report on an incident on Datix that involves a new interventional procedure including where a new interventional procedure has been undertaken at UCLH without appropriate permissions and review 1. Access Datix via the link on the UCLH Intranet home page. 2. Complete all the required fields. For the main category field, please select Treatment General. For the sub category field, please select New Interventional Procedure. Please also ensure that the lead clinician, the lead clinician s DCD and the Clinical Effectiveness Coordinator are notified. The Clinical Effectiveness Coordinator will inform the CESG. See section 16. UCLH