Human Tissue Authority

The regulator for human tissue and organs

Inspections

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:

  1. secure that other persons to whom the licence applies are suitable persons to participate in the licensed activities;
  2. secure that suitable practices are used in the course of carrying on the activity;
  3. secure that the conditions of the licence are complied with.

The HTA must also be able to

  1. satisfy itself that the applicant for the licence is a suitable person to be a holder of the licence.
  2. satisfy itself that the premises are suitable for the activity to be authorised by the licence.
  3. 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

We use the term ‘inspection’ to describe when we visit an establishment to meet with staff, view premises and facilities, and review policies and procedures. We carry out inspections to assess if the Designated Individual (DI) is suitable to supervise the activity covered by the licence, as it is their responsibility to ensure that:

  1. other staff working under the licence are suitable;
  2. suitable practices are used when carrying out the activity; and
  3. the conditions of the licence are met.

We also need to be satisfied that the licence applicant or holder, the establishment’s premises, and the practices relating to licensed activities, are suitable.

To help us reach our decisions, we have developed standards under four headings: Consent; Governance and Quality; Traceability; and Premises, Facilities, and Equipment.

After every site visit inspection, we write a report documenting our findings. Where we find a particular standard is not met, we will describe the level of the shortfall as ‘Critical’, ‘Major’ or ‘Minor’. In most cases, it will be the responsibility of the DI to determine how the identified shortfalls will be met and to seek the HTA’s agreement on a timescale for completion of corrective and preventative actions. More information about the classification of shortfalls is appended to each report. Once the establishment has met all shortfalls identified during the inspection, a statement to that effect is added to the end of the inspection report.

The majority of our site-visit inspections are announced. If we have concerns about an establishment, we can also undertake an unannounced site visit inspection.

You can find reports for site visit inspections which have taken place since 1 November 2010 in our establishment register

The HTA defines inspection as a process encompassing desk based assessment, on-site assessment and analysis of information to evaluate compliance with the conditions of a licence and HTA licensing standards. The HTA’s authority to carry out site visit inspections is defined in Schedule 5 of the Human Tissue Act and Part 5 of the Q&S Regulations.
 
Desk based inspections

When an application for a licence is received, a desk based inspection will take place. This inspection involves a thorough analysis and evaluation of the licence application submitted by the Licence Applicant and the proposed DI. This information is often supplemented with additional verbal or written information requested by the HTA during telephone interviews and email exchanges with the proposed DI and / or Licence Applicant, as part of the process. The assessment determines if our licensing standards are met and whether the HTA is satisfied with the suitability of an establishment to carry out one or more of the activities regulated by the HTA. This leads to a licensing decision such as whether to grant a licence, grant a licence with additional licensing conditions, or refuse a licence.

During the licence lifetime: At certain times during the lifetime of a licence, the HTA may ask for further information about compliance with certain aspects of the legislation or licensing standards. This may be requested in general updates to the information we hold or be specific to a particular establishment based on an aspect of the individual establishment’s performance. Once this information is received, the HTA will conduct a desk based inspection of the information and determine if our licensing standards continue to be met and whether the HTA is satisfied with the suitability of an establishment to carry out one or more of the activities regulated by the HTA.

Site visit inspections

Site visit inspections are conducted based on the findings from a desk based assessment and any other relevant information. The focus during a site visit inspection is on reviewing operational policies and procedures, inspection of premises, scrutiny of practices which involves review of documentation, and in some cases interviews with a range of staff at the establishment. This allows the HTA to identify any shortfalls in relation to the standards and the conditions of a licence, assess whether the HTA is satisfied with the suitability of an establishment to carry out one or more of the activities regulated by the HTA, offer advice on improvements which are required to be made and identify areas of good practice.

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