CENTRAL ADELAIDE LOCAL HEALTH NETWORK

NEW CLINICAL PROCEDURES, SERVICES OR OTHERINTERVENTIONS APPLICATION FORM

Part A. Clinical Effectiveness

Please note: Each section of this application can be expanded according to the requirements of the application. The completed application needs to be approved by the Clinical Director (please see signature page at the end of the application) before receipt by Executive Officer of the Committee.

Once completed and signed the application form should be sent together to:

for consideration by the CALHN New Clinical Procedures, Services or other Interventions Committee.

Applicant Details:

Date:

Name of Procedure/Service:

Chief Applicant Name:

Position / Role:

Department or Service Unit:

Facility:

Contact Telephone No*(essential):

Email *(essential):

  1. Proposal Summary

Summary Characteristics of Proposal

Type: Procedure / Device / Service / Intervention / Other:

Health Discipline: Medical / Nursing / Allied Health:

Department or Service Unit:

Facilities where service would be provided:

Number of staff who would provide service:

Estimated number of annual treatments:

Description

Audiovisual or other material that explains the procedure may be helpful and can be submitted in CD or other form.

  1. Clinical Effectiveness

Potential Benefits for CALHN Patients

What is the epidemiology of the disease(s) of interest (consider prevalence or hospital separation data) natural history and current treatment approaches. How willintroduction of this procedure change morbidity or mortality compared with current treatment options?

Scientific Rationale for Introduction in CALHN

a) List key sites nationally and internationally where this procedure is currently in use and any outcome data available

b) Is this add on technology (achieves an outcome that could not be achieved with current technology) or does it replace an existing procedure?

References for Supporting Evidence/Literature(attach copies)

Applicants should provide at least the 3 highest quality published studies evaluating this procedure. The NHMRC Levels of Evidenceprovides a guide to assessment of the literature. Other useful websites include:

How to review the evidence: systematic identification and review of the scientific literature

How to use the evidence: assessment and application of scientific evidence

How to compare the costs and benefits: evaluation of the economic evidence

Applicants should also refer to national and federal technology assessment outcomes to indicate if there is published material evaluating this procedure. Please see links below.

HealthPACT

Health Technology Assessment

Horizon Scanning

MSAC

Is there an Australian Safety and Efficacy Register of New Interventional Procedures (ASERNIP) review relevant to this application? (If yes attach a copy)

If there is a relevant ASNERP review please comment on the review and provide a copy. The website address is:

  1. Service Impact

Proposed Selection Criteria for Patient Selection

Provide details of the proposed selection, (inclusion and exclusion) criteria and the process for patient selection and referral for the procedure including the person(s) who will be responsible for selecting patients.

Inclusion criteria will be

Exclusion criteria will be

Patients will be selected by . For example: identification through department clinical review meetings, referral from another craft group or local general practitioners.

Projected Patient Numbers

Give details of expected patient numbers in the next twelve months.

Expected Impact on other CALHN Health Care Delivery Services

Consider clinical support such as pathology and imaging, and non-clinical support services. If the application impacts on other departments please list the Head of Department(s) and the outcome of discussions with them

Workforce Requirements

Include workforce requirements such as redesign, additional staff or new roles

Staffing requirements have been considered and the expected impact on is

  1. Staff Training and Credentialling Requirements

Are there specific training requirements for the proposed procedure? Please provide details

Include information on whether there are any training requirements imposed in other countries or other sites nationally and if your professional body has a position statement on qualifications and/or requirements for recognition of training in this procedure.

Credentialing

Does the new service require an extension to practitioners’ current scopes of practice?

Expected Future Training and Credentialing Requirements (including Nursing, Technicians and Allied Health staff)

New procedures often have a learning curve and may involve changes to clinical practice pre and post procedure as well as during the procedure. Please specify qualifications, training and experience required; include external workshops and supervision requirements for future practitioners who will be trained in this procedure.

  1. Other Considerations

Risk Assessment

If this procedure replaces an existing procedure consider the expected difference in risk that would occur with the introduction of the procedure. Are there data on the number of procedures per annum required to maintain expertise

Conflict of Interest Statement

Any individual associated with the procedure that has or will gain financially from its introduction or previously from its development must record the nature of that conflict of interest in the space provided.

Other Relevant Information in support of this Application

Please include advice on the state of any application with the Medicare Services Advisory Committee, the Therapeutic Goods Administration or other relevant bodies. Attach any relevant data.

Occupational Health and Safety

Occupational Health and Safetymust be considered prior to submission of the applications. Please discuss with the site OHS Manager any potentialOccupational Health and Safety issues.

Tick box to indicate if there are Occupational Health and Safety issues yes no

Infection Control

Infection Controlmust be considered prior to submission of the applications. Please discuss with the site Infection Controlofficers any potentialInfection Control issues.

Tick box to indicate if there are Infection Control issues yes no

Proposed Stopping Criteria

Please indicate what adverse event (s) you will consider a sufficient seriousness to stop using the procedure in CALHN until discussion and advice has been gained from the CALHN Executive Director Medical Services.

Please note that all adverse events must also be reported via the Safety Learning System and OHS System.

Proposed Evaluation Mechanism – Data Collection and Analysis

Include information on the database to be used and the designated manager of the data and its analysis.

Data will be collected prospectively by using a database.

Patient outcomes will be audited for a period of

Data will be stored and this location will be accessible only to .

The following variables will be collected on the database:

Proposed Evaluation Mechanism - Criteria for evaluation

Outcomes of interest that will be monitored and reported on will include the following as listed and including the proposed stopping criteria (see below):

Proposed Evaluation Mechanism – Designated Forum for Evaluation

(Including inclusion in local, State, National or Worldwide)

Results will be presented every to the meeting (insert the meeting’s name in the space provided) held every in the at .

Data will also be presented to .

Reporting of Outcomes from Introduction

It is /is not (delete incorrect response) intended that the results of this new procedure will be submitted as an abstract to a meeting of the relevant Professional Body.

It is /is not (delete incorrect response) intended that the results of this new procedure will be submitted to a peer-reviewed journal for publication.

Interface with Research

Has the procedure previously been submitted to the CALHNHuman Research Ethics Committee?

If yes please tick box and attach documentation of the outcome

Notes to Applicants/Heads of Department for Part A.

  1. Applicants

It is required that applicants discuss the proposal with the relevant Head of Unit and consideration is given to the appropriateness of the request Endorsement from Head of Unit is necessary before completion of the application.

Please contact r assistance to complete the application and gather the documentation required to assist the CALHN New Clinical Procedures, Services or other Interventions Committee make a determination.

All sections of the application form need to be completed. This includes the signatures of the relevant managers as this indicates directorate support for the proposed introduction of this new clinical procedure, service or other intervention including the assessment of the implications for patients and the organisation. Incomplete applications will be returned to the applicant.

Completed and signed off applications need to be submitted to

to provide sufficient time for the application to be reviewed and processed. The application will be considered at the next monthly meeting unless the application requests an urgent out of session consideration and that request is endorsed by the Chair of the Committee.

2. Unit Heads

On receipt of an application consider the value of an initial assessment meeting of key individuals, especially in relation to difficult cases. This request for a meeting should be directed to the Directorate Director, as the line manager. The meeting could include for example, the following key individuals:

Department Head

Directorate Clinical Director or delegate

Applicant

CALHN Executive Director Medical Services

The meeting’spurpose is to make an initial assessment of the proposed course of action, and the needs of any urgent patient. The meeting would be prior to finalising the application for consideration by the Committee. The group should consider the following key issues:

What is the urgency of the clinical need?

Is the procedure suitable for introduction into and can it be performed safely in the proposed unit or facility?

What action is required to complete the submission process?

Approvals Required Prior to Submission of the Application(PART A)

NOTE: Applications involving more than one department or service require sign off by the Head of Department and Management in each area. If the application relates to more than one site, sign off is required by all sites.

Date / Name / Signatures
Applicant
Applicant (if more than one)
Unit Head
Clinical Director(must be signed)

Sign off by Unit Headindicates agreement with the scientific evaluation; the assessment of “clinical fit”; the proposed credentialing requirements for approved operators and proposed mechanism for evaluation as well as agreement to provide the proposed Department forum for evaluation and appropriate support for other proposed mechanisms for evaluation.

Sign off by the Clinical Director indicates support for the Introduction of this procedure into the Directorate by the proposed operator as a priority initiative and its ongoing evaluation.

This section is to be signed after approval by CALHN New Clinical Procedures, Services or other Interventions Committee. Part B will also need to be signed by the CALHN New Clinical Procedures, Services, or other Interventions Committee prior to implementation.

Chair CALHN New Clinical Procedures, services

or OtherInterventions Committee______(sign)

______(printname)

______Date

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CALHN NEW CLINICAL PROCEDURES, SERVICES OR OTHER INTERVENTION APPLICATION FORM