Implementation of High Risk Human Papilloma Virus (Hr-HPV) Primary Testing

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1 Implementation of High Risk Human Papilloma Virus (Hr-HPV) Primary Testing Background In Nov 2015 following a review of evidence the UK National Screening Committee made a recommendation to the UK countries to adopt high risk HPV primary testing into the Cervical Screening Programmes. Scottish Government made a commitment to implement Primary HPV testing which was included as an action in the cancer strategy plan in March As a result Scottish Government made a request to develop a Full Business Case to fully cost the preferred model to replace cytology as a primary screening test with hr-hpv testing and use cytology based tests as the triage for women who test positive for HPV. The implementation of Hr-HPV Primary Testing was announced by the Scottish Health Minister on the 11th August following approval of the Full Business Case. The Change The change sees the replacement of cervical cytology as the primary screening test with Hr- HPV testing and the use of cytology-based tests as the triage for women who test positive for Hr-HPV. HPV has been identified in the majority of cervical cancers. The introduction of this new test will help ensure the early signs of cervical cancer are identified and treated earlier. The developments will also see Scotland's cytology laboratory service reconfigured from the current seven NHS Board-run cytology labs to become one of two 'super labs' delivering both HPV and cytology testing. The two labs will be centrally commissioned. The Project The project officially commenced September A project team was recruited, contact details below: Hr-HPV Implementation Project Manager - joanne.milne-toner@nhs.net Hr-HPV IT Implementation Project Manager rosswalker@nhs.net Hr-HPV Implementation Programme Support - Donna.McLean2@nhs.net

2 The Implementation Board An Implementation Board was established and provides overall project governance and reports to the Scottish Screening Committee via National Specialist and Screening Services Directorate (NSD). Six implementation groups, to ensure successful delivery of the change, have been established: IT Procurement Clinical Governance Communications and Engagement Laboratory Reconfiguration Group QA/EQA/Data Group IT Implementation Group The Group will review and approve key IT project deliverables, represent the needs of users and reviews and approves UAT test acceptance criteria and test reports. A User Group has been established to carry out User Acceptance Testing (UAT) to ensure the system is operationally effective and clinically safe. The current IT system (Scottish Cervical Call Recall System SCCRS) is being developed by Atos to accommodate the change in primary test. Five iterations of software releases have been identified for which test scripts and UAT Test Environment will be developed/performed. Procurement Group The Group is developing the tender documentation and specification for the managed service contract to deliver both cervical cytology and Hr-HPV testing within two laboratories. The scope of which includes the following; Supply of sample taker and laboratory consumables and disposal Transport of samples to processing laboratories Hr-HPV testing equipment Cytology testing equipment Installation and maintenance of equipment Training Transfer of results back to SCCRS

3 Clinical Governance Group The Group is responsible for reviewing and agreeing the procedures for the following situations:- Transferring women on non-routine recall to HPV testing Exit strategy from screening for woman HPV+ve at their last screen Management of women HPV+/colp negative at 24 months following HPV+/triage negative result Protocols for adding biopsy results Arrangements for screening laboratory participation in the National Invasive Cancer Audit Cross border issues with England The handling of SCI gateway referrals Management on non-sccrs results Communications and Engagement The Group is developing a detailed communications plan that will ensure clear and consistent messages about the changes are delivered to the public and relevant health care professionals. Including the following: A review and redevelopment of all current information materials to participants To provide FAQ s for HCP s. These will be circulated and uploaded onto SCCRS and various websites To provide appropriate updates to relevant sample taker training packages To carry out a Health Inequalities Impact Assessment to ensure all communications are appropriately targeted Laboratories Reconfiguration Group The development of transitional arrangements and managing the transition plan with the selected laboratories including bringing in the workload. Work closely with the Consortia to ensure the sustainability of the laboratory service until implementation. Governance will remain within NHS Boards. The EQA Scheme and Training school will be out with the scope of this group. These are nationally commissioned services by NSD who will have the responsibility of reviewing the requirements and needs of the groups moving forward. No Change is envisaged to the Call/Recall role.

4 The Independent Laboratory Evaluation Panel On behalf of the Hr-HPV Primary Testing Implementation Board, an Independent Laboratory Evaluation Panel was established with responsibility for providing a recommendation on the two laboratories to deliver both cervical cytology and Hr-HPV testing into the Scottish Cervical Screening Programme. The Panel s role was to: Review and refine the selection criteria and weightings set out in the full business case. Evaluate and score the proposals to identify the two laboratories to deliver both cervical cytology and Hr-HPV testing for the Scottish Cervical Screening Programme. Ensure scoring of proposals was conducted objectively and in confidence. Make every effort to arrive at consensus decision. This also included considering other factors out with the scoring if required. Documenting the rationale for the final decision and making a recommendation to the Implementation Board. Membership The membership of the Independent Laboratory Evaluation Panel is outlined below. The following panel members evaluated and scored the proposals. Name: Job Title: On Behalf of: Joy Tomlinson Interim Director of Public Public Health Directors Health Roderick Harvey * (23 rd Oct Mar 2018) Medical Director Medical Directors Boyd Peters (15 th Mar 2018 present) Bill Bartlett Associate Medical Director Joint Clinical Group Director (Diagnostics) Medical Directors Shared Services / Director Diagnostics Tim Palmer Clinical Lead Scottish Cervical Screening Programme Grant Stenhouse Lead Consultant Pathologist Scottish Pathology Network * Following advice that Dr Roderick Harvey was unable to evaluate and score proposals a deputy Dr Boyd Peters was sought. The following were members of the panel but did not evaluate or score the proposals: Jim Miller (Chair), Director of PCF, NSS - independent referee throughout the process and to make the recommendation to the Implementation Board. Tracey Curtis, Senior Programme Manager Scottish Cervical Screening Programme, NSD - to provide support and advice to the panel and collate scoring and reports for consideration by the hr-hpv Primary Testing Implementation Board and NHS Board Chief Executives. Sue Payne, Public Health Advisor, Scottish Government - to observe and contribute.

5 The Independent Laboratory Evaluation Panel recommended to the hr-hpv Primary Testing Implementation Board that NHS Lanarkshire & NHS Greater Glasgow & Clyde deliver both cervical cytology and Hr-HPV testing for the Scottish Cervical Screening Programme. The recommendation was ratified by the Board. QA / EQA / Data Group The responsibility of the Group is to address the following: Internal Quality Controls and External Quality Assurance for hr-hpv primary testing and triage cytology How is the end-to-end quality of the primary HPV screening process assured What changes will be required for reporting ensuring that the data is available to users Review of all fail-safe procedures Review the content of screening reports published by Public Health Intelligence Consider the revision of the National Invasive Cancer Audit dataset. Newsletter Please find project newsletters below which provides updates on the general project and the implementation groups. Primary Hr-HPV testing newsletter v 1. Primary Hr-HPV testing newsletter v 2.