Inspections
As part of our regulatory function the HTA will carry out inspections of licensed establishments. This section provides more information about the inspection process.
Under the Human Tissue Act 2004 (HT Act) the HTA has a statutory responsibility to make judgements about the suitability of: the Designated Individual; Licence Applicant (Holder); premises and practices in relation to the licensed activities. These responsibilities are set out in Schedule 3 to the HT Act and are summarised below for ease of reference. This framework is the basis of the HTA’s approach to licensing and inspection.
The HTA must satisfy itself that the Designated Individual (DI) is a suitable person to supervise the activity to be authorised by the licence and that they will undertake the following duties.
- secure that other persons to whom the licence applies are suitable persons to participate in the licensed activities;
- secure that suitable practices are used in the course of carrying on the activity;
- secure that the conditions of the licence are complied with.
The HTA must satisfy itself that the applicant for the licence is a suitable person to be a holder of the licence.
The HTA must satisfy itself that the premises are suitable for the activity to be authorised by the licence.
To fulfil its statutory responsibilities the HTA must be able to assess whether an establishment is suitable to carry out one or more of the activities regulated by the HTA. Suitability will be assessed through a process of inspection.
The inspection process
The HTA has developed an inspection programme that falls into two phases. The first phase of the inspection programme will be an evaluation of the compliance report licence application. A Regulation Manager or Head of Regulation will make a licensing decision based upon the evaluation – whether to grant a licence, grant a licence with additional conditions, or on rare occasions refuse to grant a licence.
The second phase of the programme will be inspection site visits. In the majority of cases establishments will have due notice of an inspection site visit, however, occasionally the HTA will carry out unannounced inspection site visits. The powers of the HTA to inspect are set out in the Human Tissue Act (Schedule 5).
Phase two inspection site visits will be planned using the information gathered during phase one. A risk-based approach will be taken to planning phase two inspections. This means that establishments identified during phase one of falling below standard in one or more areas of the compliance report will generally be inspected before establishments that meet all the standards. An evidenced based report will be produced on the findings of the site visit. Following the site visit a licence may be varied to add additional conditions, or other regulatory action such as special directions, suspension or revocation of the licence may occur.
The HTA has a statutory duty to provide advice and guidance to those we regulate. Inspection site visits provide an excellent opportunity for gathering additional information, for example on developments within a sector. To make best use of this opportunity the HTA will apply a ‘theme’ to all inspections over a given period, so for instance in the first year of phase two inspections the theme might be consent. An analysis of findings from the inspection programme can then be fed back as advice and guidance to licensed establishments so that they can learn from others and develop methods to improve standards.