Code E: HTA licensing standards

131.    In order to obtain a HTA licence, the applicant must demonstrate that they and the relevant premises are suitable. The HTA will assess whether they can meet a number of core Standards, which were developed in consultation with representatives from the regulated sectors. These relate to the consent provisions of the HT Act and the regulatory requirements for governance and quality systems, traceability and premises. They reinforce the HT Act’s intention that:

a)    consent is paramount in relation to activities involving the removal, storage and use of human tissue
b)    bodies of the deceased and organs and tissue removed from bodies are treated with respect
c)    the dignity of the person, whether living or deceased, is maintained.

132.    The HTA works with establishments through its inspection process to help them comply with these Standards.

133.    Each licensed establishment is required to appoint a Designated Individual (DI) for their licence, who has a statutory responsibility under the HT Act to supervise activities taking place under a licence. The DI has a duty to ensure that suitable practices are carried out by those working under the licence, that the premises are suitable and that the conditions of the licence are complied with. By ensuring that the establishment is meeting the HTA’s licensing Standards, the DI will be meeting their statutory responsibility.

134.    When HTA staff undertake inspections of HTA-licensed establishments, they make judgements about the suitability of the Licence Holder (LH), the DI, the practices taking place and the premises on which they take place. They do this by assessing the establishment’s compliance with the HTA’s licensing Standards, which reflect the guiding principles set out in Code A and provide the operational detail of how establishments should meet the requirements of the HT Act and the Codes of Practice.

135.    The HTA’s licensing Standards are grouped under four headings: Consent (C); Governance and quality systems (GQ); Traceability (T); and Premises, facilities and equipment (PFE). Under each of these headings, there are overarching statements, from which the standards flow.
 

136.    Establishments meeting the consent Standards will be able to demonstrate that their processes for seeking and gaining consent comply with the HT Act and the HTA’s Codes of Practice. The standards also cover the documentation and information used to support the establishment’s consent procedures, and ensure that staff involved in seeking consent are suitably trained and equipped for the task.

137.    Establishments meeting these standards will be able to demonstrate that they have a suitable governance framework, underpinned by clear and controlled documentation, effective audit, staff training and organised record-keeping. In addition, they will have an effective system of risk management and suitable systems to deal with adverse events.

138.    Establishments meeting these Standards will be able to demonstrate full traceability for the human material for which they are responsible, from receipt to final disposal/disposition. HTA inspectors will test this through traceability audits carried out on site and we expect establishments to take a pro-active approach to assuring themselves of effective traceability throughout the lifetime of their licence. In addition, as the final traceability step, they will have established disposal arrangements which are in accordance with the HTA’s Codes of Practice

139.    Establishments meeting these Standards will be able to demonstrate that their premises and facilities are appropriate for their licensed activities and are safe, secure and clean. In addition, establishments will have systems for on-going monitoring to ensure all key quality specifications are maintained. These Standards also cover equipment, ensuring that it is appropriate, and suitably maintained, and that it does not present an impediment to the staff using it.

140.   The HTA licensing Standards which will be applicable to the Research sector from April 2017 are included at Annex D and on the HTA website. The Standards are supported by comprehensive guidance notes.