The role of the Person Designated Pravat Bhattacharyya HTA - - PowerPoint PPT Presentation

The role of the Person Designated

Pravat Bhattacharyya HTA Regulation Manager

March 2015

Overview of presentation

The HTA licensing framework How PDs can support a DI Where PDs can be based Communication between DIs and PDs

HTA licensing framework

 Licence Holder

 Normally a corporate entity  Named Corporate Licence Holder contact (CLHc)  CLHc typically more senior to DI

 Designated Individual (DI)

 Statutory role in Human Tissue Act 2004

 Persons Designated (PDs)

 Responsibilities not defined, as for DIs, in HT Act

 ‘Guide to Licensing for Designated

Individuals and Licence Holders’

Suitability of the DI (s18 of HT Act)

“It shall be the duty of the individual designated in a licence as the person under whose supervision the licensed activity is authorised to be carried on to secure (a) that the other persons to whom the licence applies are suitable persons to participate in the carrying-on of the licensed activity, (b) that suitable practices are used in the course

• f carrying on that activity, and

(c) that the conditions of the licence are complied with”

The importance of PDs

PDs can support a DI by providing local oversight

• f licensed activities

PDs can support a DI by providing local oversight of licensed activities A DI can nominate PDs to report a potential HTARI to HTA PDs can update a DI on activities in their areas, bringing to their attention any concerns

How PDs can support a DI

 Contribute to quality management

 Carry out audits  Write and review SOPs and risk assessments  Train non-mortuary staff

 Cascade information to colleagues locally  Report an HTARI within five working days if

nominated to do so

 A DI should nominate as many PDs as they feel

necessary for them to fulfil their statutory responsibilities under s18 of the HT Act

 Depending on scope of activities and size of organisation

Where do we expect to find PDs?

Mortuary

Histopath lab

Satellites

Where can PDs also be useful?



Storage areas for relevant material for use for scheduled purposes

 Research collections  Education and training  Existing holdings



Accident and Emergency

 Removal of tissue samples from deceased infants



Bereavement Services

 Seeking consent for PM examination



Maternity

 Temporary storage of neonates en route to mortuary  Consent for perinatal PM examination



Operating theatres (where DI has responsibility for this)

 Removal of tissue samples from deceased persons for use for

scheduled purposes

Communication

Virtual meetings Email circulation PDs can attend, for example Conferences HTA training events Receive e-newsletters Regular governance meetings involving DI and PDs Cascade of information, including news from HTA Issues arising, including incidents and near misses How inspection findings are being addressed

At an HTA site visit inspection

 Confirm PDs are in place where licensable

activities are being carried out

 Assure ourselves the risk of non-compliance is

mitigated by the presence of a PD

 Check PDs awareness of

 HT Act, Codes  HTARIs

 How DI and PDs communicate

 Formally / informally  In case of an HTARI / near miss

Summary

 DI retains overall responsibility  PDs can be a DI’s ‘eyes and ears’ in areas

where licensable activities take place

 PDs can help a DI to ensure licensing

standards are being met

 Inform us of changes to PDs on your licence

 New PDs / PDs leaving  Email notification (licensing.enquiries@hta.gov.uk)  Provide contact details and job title  No charge!

 E-newsletter mailing