Work Packages

Work Packages

work packages

Portfolio reference number: / Breast Implant Registry
  1. Overview

This Agreed Work Package is entered into under and incorporates the provisions set out in the Agreement between HSCIC and DH dated [ ].
This Agreed Work Package is entered into by and for the primary benefit of DH ("Customer"). HSCIC ("Supplier") shall be performing theservice.
The purpose of this work package is to commission the HSCIC to develop and maintain a Breast Implant Registry for 2015/16 and 2016/17. After this time, the Registry aims to be self-funding.
  1. The Objective

The Objective of the Parties is to develop and maintain a Breast and Cosmetic Implant Registryto support implementing Recommendation 21 of the Keogh Review of the Regulation of Cosmetic Interventions
“A National Breast and Cosmetic Implant Registry should be established and operational within 12 months. All cosmetic surgery providers need to keep a minimum data set that should be defined by the RCS Inter-specialty Group. This should include details of the implant, the surgeon, the hospital and appropriate outcomes, and these data need to be held in electronic format until the registry is operational. These data should be easily accessible in the case of a product recall”.
The priority is to develop and maintain a breast implant registry. However, the long term vision is to expand the registry to other types of implant, for example, buttock and calf implants.
  1. The HSCIC Senior Management Team

HSCIC Responsible Director: John Varlow, Director, Information and Analytics
Senior Responsible Officer: Julie Henderson, Head of Analytical Services
Service Lead:Alyson Whitmarsh, Clinical Audit Team Manager
The names and addresses for notices shall be as set out in the MOU.
  1. The DHSenior Management Team

DH Lead: Simon Reeve, Head of Public Health Policy and Strategy Unit
DH Service Lead: Bill Jobson, Public Health Policy and Strategy Unit
The names and addresses for notices shall be as set out in the MOU.
  1. Schedule for the work package with output based deliverables

Term / This Project shall commence on 1st August 2015 and is expected to expire 31st March 2017("Term"). The Term may be extended by the written agreement of the Parties.
Services Description / The key HSCIC deliverables are as follows;
  • Develop an appropriate dataset for the Breast Implant Registry. This will include mapping to existing clinical terminologies and classifications as appropriate.
  • Data will be collected from:
  • Private cosmetic surgery clinics, providing breast augmentation services.
  • NHS Providers of reconstructive and plastic surgery.
  • Trace NHS numbers, where not available, and where possible to trace.
  • Track latest known address in the event of a product failure.
  • Monitor the outcomes achieved by ‘brand’ of prosthesis, hospital and surgeon, and highlight where these fall below an expected performance in order to allow prompt investigation and to support follow-up action.
  • Publish data in line with its responsibilities under the Statistics and Registration Services Act 2007 (SRSA) and relevant professional guidance including the UK Statistics Authority Code of Practice for Official Statistics. HSCIC may also publish in other forms, manner and times that it considers appropriate following consultation with DH
  • Disseminate data in line with its responsibilities under relevant legislation and guidance following consultation with DH.
The Department will provide a project manager to coordinate the Department’s role in the requirement.
The HSCIC shall provide the following:
  • A senior responsible officer, for HSCIC accountability
  • A service lead to oversee the development and delivery;
  • A delivery manager and co-ordinator to develop and deliver;
  • Sufficient technical input to ensure the systems are developed and managed
  • Sufficient analytical expertise and resource to provide the reporting and dissemination function

This section constitutes the complete description of the services to be provided for the Breast and Cosmetic Implant Registry.
The Supplier shall be entitled to use any of its staff in the provision of the Services including its employees, contractors and subcontractors.
Data Protection / HSCIC is the Data Controller and the Data Processor for purposes of this work package.
Testing and Acceptance Criteria / The testing of the collection, including collection vehicle will be carried out by end users via Pilot phases of development during 2015/16
  1. Milestones and Milestone Dates

The following Milestones detail the services / deliverables to be completed by the associated Milestone dates.
Milestone Name / Milestone Date / Charges Payable / Delay Payments (if applicable)
Develop communication plan / Sept 15 / Fixed price, payable quarterly
Identify, agree and implement necessary governance arrangements to include legal basis, consent model and information standards requirements / Oct 15
Minimum dataset agreed and coding established / Nov 15
Establish data migration requirements from pilot registry and plan as appropriate / Dec 15
Directions agreed and in place* / Jan 16
Develop and test submission route to registry / Jan 16
Go live with registry data capture / Feb 16
Develop track and trace mechanism / Feb 16
Migrate pilot data where appropriate / Feb 16
Pilot track and trace mechanism / Mar 16
Develop reporting functionality / Mar 16
Go live with track and trace mechanism / Apr 16
Develop operating model proposal for self-funding (post 2017) / Jul 16
*The date that directions are agreed and in place will affect and determine subsequent milestone dates.
  1. Charges and Payment

The rates contained within the pricing schedules are, unless otherwise expressly agreed between the parties, firm.
The rates entered shall be deemed to include complete provision for full compliance with the requirements of the Contract.
The rates include VAT.
The rates entered in the Schedule of Prices shall include all travel and subsistence costs which must be set out separately. Expenses will only be approved if supported by original receipts. DH will only pay for expenses claimed that are in line with the Department’s guidelines for expenses. Original receipts will need to be provided.
DH will only make payment for overnight stays authorised beforehand by the DH's Representative.
The Department will only pay for expenses claimed that are included in this pricing schedule and are deemed to be reasonable for delivery of the requirement.
The HSCIC will invoice DH quarterly. The first two quarters for Year 1 will be invoiced at the same time, i.e. September.
DESCRIPTION OF SERVICE / FIRM PRICE
Delivery of Breast and Cosmetic Implant Registry
2015/16 - Year 1 / 191,024
2016/17 – Year 2 / 138,607
VAT / 65,926.20
Total Price / 395,557.20
Additional Documentation
None
  1. TUPE

The Parties agree that at the commencement of the provision of the Services by the HSCIC, TUPE and the Cabinet Office Statement shall not apply so as to transfer the employment of any employees of DH or a third party to the HSCIC and the provisions of Schedule 2 shall not apply.
  1. Special Terms

None
  1. Asset Register

The Parties acknowledge and agree that pursuant to the terms of the MOU that within 14 days of the execution of this Agreed Work Order, HSCIC shall update the Asset Register if necessary with the title, reference number and date of this Agreed Work Order.

Signed on behalf of HSCIC

Carl Vincent

Director of Finance and Corporate Services

Date:

Signed on behalf of Department of Health

[INSERT NAME OF AUTHORISED SIGNATORY]

[INSERT JOB TITLE]

Date:

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