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Understanding the Roles of Licence Holder and Designated Individual in Oversight and Compliance

This document aims to clarify the roles and responsibilities of the Licence Holder (LH), Designated Individual (DI), and Persons Designated (PD) in regulatory frameworks. It outlines the inspection process, statutory duties of the DI, and offers guidance for better preparedness during site visits. The text discusses governance systems, quality assurance, and effective communication channels between the DI and corporate bodies, emphasizing the importance of compliance with licensable activities. Key information regarding HTA inspections and support resources is also highlighted.

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Understanding the Roles of Licence Holder and Designated Individual in Oversight and Compliance

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  1. Decoding the role of the DI 21 October 2009 Kate Rolfvondenbaumen

  2. Aims and outcomes • to help you understand the roles of the: • Licence Holder (LH) • Person(s) Designated • Designated Individual (DI) • provide you with information about the inspection process • help you and your staff be better prepared for a site-visit inspection

  3. The role of the LH

  4. Role of LH • term not defined in the Act; but the HTA must be satisfied that the applicant is suitable • HTA has a preference for the LH to be a corporate body, with a named contact • Ideally someone in a managerial capacity in the establishment • the LH has the right to vary a licence • can submit application to vary licence by changing the DI

  5. The role of the LH in practice • In practical terms, the DI is typically the key person, with a two-way flow of communication occurring between the DI and the corporate body

  6. The role of the PD

  7. Role of the PD • no legal duty • ability to “direct” others in relation to the Act -assist DI with development and implementation procedures -work at a satellite offering advice and guidance -oversee licensable activities on behalf of the DI

  8. The role of the DI

  9. Statutory duty of the DI It is the duty of the DI (paragraph 18) to secure that: • other persons who work under the licence are suitable to participate in the licensable activities • suitable practices are used in undertaking those activities • conditions of the licence are complied with

  10. Statutory duty of the DI cont. The DI is the lynchpin of regulatory compliance under a licence How does the HTA help you? • advice and guidance: website, codes of practice, email and telephone • face-to-face training and e-learning • conferences • e-newsletter

  11. DIs and HTA Inspections

  12. HTA responsibility Legal obligation to satisfy ourselves that: • both the DI and the LH are suitable • the establishment has appropriate premises, facilities and equipment • all procedures are carried out to required standards • governance and quality systems are in place

  13. HTA inspections • desk-based (all establishments) • site-visit (based on risk) • routine, non-routine and unannounced

  14. Risk-based approach • use a risk matrix to inform scheduling of site- visit inspections • also consider DI response time, DI training and whistleblowers

  15. Consent • review the consent process • looking into the communication flow between you and the coroner

  16. Governance and quality systems • SOPS and RAs for licensable activities • records to demonstrate traceability • examples of forms used • training records • internal audits • document control • meetings

  17. Premises, facilities and equipment • Range of licensed premises – ensure that: • premises and facilities are fit for purpose • SOPs are in place for the management of equipment and materials • risk assessments have been undertaken • maintenance and cleaning records exist

  18. Disposal • policy in line with HTA codes of practice • records of disposal in place

  19. Personnel • DI must ensure that: • personnel are suitably qualified • there are sufficient staffing levels • staff receive training and CPD • appropriate staff facilities are in place, including protective clothing and equipment

  20. Summary DIs have a statutory role to fulfil The DI has a critical role in inspections: • Before: providing needed information • During: ensuring staff are present ensuring all documentation is present • After: reviewing the report communicating the information in the report ensuring compliance with additional conditions

  21. Fact or fiction

  22. Number 1 The DI must be a doctor Fact: The HT Act does not stipulate any specific academic qualifications for the DI

  23. Number 2 All establishments must have at least one, but no more than three, PDs on a licence Fact: The HTA is not prescriptive about the number of Persons Designate on a licence.

  24. Number 3 Not all changes to a licence need to be reported to the HTA Fact: The DI has a responsibility to ensure that HTA is kept informed of all changes to a licence in a timely manner

  25. Any questions?

  26. www.hta.gov.ukSubscribe to our e-newsletter on our website

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