Summary Inspection Reports

1. Summary Inspection Reports Dr Sandy Mather Director of Regulation

2. Introduction • How do we regulate? • What are the summary inspection reports? • What have we found on inspection?

3. How do we regulate?

4. How do we regulate? • Compliance based approach • Regulatory Action Panels • Where significant regulatory action is considered • Complex regulatory issues • Fair, proportionate and justifiable • Enforcement action • Verbal and written advice and warning • Heightened risk inspection • Additional conditions, special directions, suspensions, revocations

5. What are the summary inspection reports? • Foreword and executive summary • Overview of the sector for the period of the report • Analysis of additional conditions and advice and guidance • Compliance with HTA standards • Consent • Governance and Quality Systems • Premises, Facilities and Equipment • Disposal • Appendices including • Licensing and inspection processes • Human application - Third Party Agreements and licensing standards

6. What are the summary inspection reports? • Analysis of learning from two years of inspections • Regulatory standards in five diverse licensable sectors • Objective analysis of how well professionals meet National and European standards when working with human bodies, tissue and cells • Share learning, drive up standards and build confidence

7. What have we found on inspection? • Some things are going well in all sectors • Good understanding of consent requirements • Genuine commitment to care for the deceased • Willingness to comply with regulatory rules • Most professionals act quickly to fix things when we find deficiencies

8. What have we found on inspection? • Some things could be better • Improvements are needed in governance and quality systems across all sectors • There are particular areas for improvement in two sectors • Human application sector • Post-mortem sector

9. Human application inspection report • 51 site visit inspections in 2007 - 2008 • 127 additional conditions • 472 items of written advice and guidance • Five regulatory action panels • Four sets of special directions (immediate action needed) • Four reactive inspections (two unannounced)

10. Human application inspection report • Governance and Quality Systems • Advice - 49 (96%) establishments; mandatory conditions - 32 (63%) • Under developed quality management systems • Immature systems for reporting serious adverse events and reactions • Inadequate Third Party Agreements for licensable activities • Premises, Facilities and Equipment • Advice - 41 (80%) establishments; mandatory conditions - 21 (41%) • Inconsistent and inadequate environmental controls in laboratories where human tissues and cells are processed • Variable cleaning and decontamination procedures

11. Post-mortem inspection report • 49 site visit inspections in 2007 - 2008 • 98 additional conditions • 339 items of written advice and guidance • Four regulatory action panels • Three sets of special directions (immediate action needed) • Two reactive inspections (one unannounced)

12. Post-mortem inspection report • Governance and Quality systems • All premises we inspected have difficulties meeting standards for governance and quality systems • Quality management and risk assessment is underdeveloped • Mortuary staff (APTs) have insufficient opportunity for professional development

13. Post-mortem inspection report • Premises, facilities and equipment • Improvements needed in 94% of sites we inspected • Mortuaries vary enormously in age and condition • Some are in need of investment and upgrade • Design and layout of some of the busiest mortuaries makes it difficult to implement standards of good practice

14. Post-mortem inspection report • Disposal • 47% of sites we inspected are not meeting standards for disposal of human tissue • There is often uncertainty about families’ wishes about disposal of material retained during a post-mortem • Pathologists are not always informed when the coroner has completed his investigation • Sometimes the bereaved have not made a decision

15. Research inspection report • 236 licensed premises • Overall level of compliance with HTA standards is good • Some exemplary governance systems • Guidance in the Code of Practice on Research • Three regulatory action panels • Main areas for improvement • Governance and quality systems • Systems for audit and traceability

16. Anatomy inspection report • 45 licensed premises • Overall level of compliance with HTA standards was good • One regulatory action panel • One set of Special Directions (immediate action needed) • One unannounced inspection • Main areas for improvement • Governance and quality systems • The management of adverse events

17. Public display inspection report • 13 licensed premises • Two establishments licensed for temporary exhibitions • Generally good compliance with the HTA standards • Good governance systems in place

18. Taking this work forward • Written and verbal advice and guidance • Codes of Practice • Inform future training for Designated Individuals • Revision of our risk assessment methodology to improve how we target inspections • Joint working with professional associations

19. Summary • There is a good understanding of the need for consent • Improvements are needed in governance and quality systems across all sectors • Particular improvements are needed in the human application sector and the post-mortem sector • Professionals show a willingness to comply with regulatory rules • Public can be confident that regulation is working