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Regulatory and Register Management

Regulatory and Register Management. Dan Howard Andrew Leonard. Chief Information Officer Senior Inspector 05 March 2019. Achievements – Information and IT. Completed restructure – five teams reporting to CIO providing leadership, resilience, stability and improvements

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Regulatory and Register Management

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  1. Regulatory and Register Management Dan Howard Andrew Leonard Chief Information Officer Senior Inspector 05 March 2019

  2. Achievements – Information and IT • Completed restructure – five teams reporting to CIO providing leadership, resilience, stability and improvements • OTR – 308 completed during past year, 99.3% within target, excellent applicant feedback • Register – operational queries and quality improvements • IT infrastructure stable and fully supported • New Intranet & HR system launched • Progress on PRISM / new Register / DM • New website and clinic portal – embedding benefits • IT support improvements - internal and EDI

  3. Information and IT team structure Chief Information Officer • Five teams • Opening the Register • Register Management • IT System Management • Software Development • Information Governance PRISM / Data submission project team

  4. Strategic Risks • CS1: Cyber security: • Effective mitigations, continual improvements and assurance from recent audit • Residual risk score 9

  5. Operational risks • Wider staffing changes e.g. Information Governance Manager, Development team • Key system availability (Epicentre, TRIM) • Impact of PRISM / DM on business as usual • IT support – downtime affects productivity • DCR service deteriorates ahead of new • Pace and breadth of work

  6. Opportunities • Refresh of Choose a Fertility Clinic data • Launch and embedding PRISM and new register • better quality data, easier data submission, intelligence benefits • Award DCR contract • Award IT infrastructure support contract • Complete recruitment to key roles • New Electronic Document Management system / Licensing system review • Donors - New digital DCR service and planning for impact from 2005 donor anonymity changes ahead of 2021

  7. Achievements – Compliance (1) • State of the sector report 2017-18: Good data in one place 2018-19 not completed, so accurate data not yet complied but: • The number of licensed centre has increased to 137 • Non compliance rates seem to have declined.

  8. Achievements - Compliance (2) • Delivered a full inspection programme in 2018/19 • Seven difficult cases which led to additional inspections and, for some centres, licensing implications including one revocation. • 2019/20: Similar inspection numbers though additional/initial inspections for compliance concerns and licensing applications are an unknown (?)

  9. Achievements – Compliance (3) • 53 PGD applications processed to date in 2018/19 versus 50 applications in 2017/18 • Developed and implemented of an end to end process to review ITE-TCS import certificate applications, to issue and log certificates and to renew certificates synchronised with licence renewal. • 140 ITE-TCS import certificate applications processed to date in 2018/19. • At least the same numbers of PGD and ITE-TCS import certificate applications are likely in 2019/20

  10. Compliance team structure Chief Inspector x3 Senior Inspectors x10.5 Inspectors x1 Clinical Governance lead x0.5 CG support x2 Business Support x1 Senior Inspector (information quality) Summer 2019

  11. Strategic Risks • RE1: Regulatory effectiveness – creating new culture in clinics our big challenge • Associated with capability, capacity and change

  12. Progress and plans 1 • New CoP requirements and guidance embedded in inspection methodology: e.g. Leadership; Patient Support; Information; Consent; Counselling; Treatment implications; Surrogacy; Screening; OHSS; Data protection; Data submission; Import and export Need to assess effectiveness • Working with Policy team to develop Leadership and Patient Support requirements, expectations, and development tools • Considerable work with the sector in the last year and going forward to promote the Leadership and Patient Support agenda as routes to making real improvements in the patient experience and compliance

  13. Progress and plans 2 • Incoming Senior Inspector to work with the information team to develop register submission inspection methodology • Developing risk-based approach to inspection scheduling and delivery to better use resources. • Soon to release revised report templates which are more patient friendly

  14. Opportunities • Inspect more proportionately and maximise the effective use of our resources, through the use of information and intelligence to inform risk-based inspection scheduling and delivery. • Add value and improvement at inspection. • Continue to drive improvements in the sector through proportionate regulation and working with centres, e.g. multiple births reduction, LP consenting • Drive the Leadership and Patient Support agenda to facilitate better patient care and centre compliance

  15. Operational risks • Staffing • EU exit • IT resilience – down time hits inspector productivity • Pace and breadth of work – inspections which are difficult, unknown numbers of additional inspections - EU exit - regulatory changes e.g. Leadership/patient support - a relatively new team across the HFEA to provide advice to. Little room for manoeuvre in the work load – resource balance.

  16. Any questions?

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