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Decoding the role of the DI. 21 October 2009 Kate Rolfvondenbaumen. 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
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Decoding the role of the DI 21 October 2009 Kate Rolfvondenbaumen
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
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
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
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
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
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
DIs and HTA Inspections
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
HTA inspections • desk-based (all establishments) • site-visit (based on risk) • routine, non-routine and unannounced
Risk-based approach • use a risk matrix to inform scheduling of site- visit inspections • also consider DI response time, DI training and whistleblowers
Consent • review the consent process • looking into the communication flow between you and the coroner
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
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
Disposal • policy in line with HTA codes of practice • records of disposal in place
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
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
Number 1 The DI must be a doctor Fact: The HT Act does not stipulate any specific academic qualifications for the DI
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.
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