Anatomy Licensing Standards and Guidance

The purpose of this guidance is to assist licensed establishments to meet the HTA’s licensing standards. The documents contain additional information and examples of how to meet certain Standards

About the standards

In order to obtain an HTA licence, the applicant must demonstrate that:

  • the premises where the activity will take place are suitable
  • the proposed Designated Individual is a suitable person to supervise the activity

As part of the application process, the HTA will assess whether the establishment can meet a number of licensing Standards. These were developed in consultation with representatives from the Anatomy sector. These relate to the consent provisions of the Human Tissue Act 2004 (HT Act), governance and quality systems, traceability and premises.

The Standards reinforce the HT Act’s intention that:

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

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

The 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.

Consent Standards

Governance and quality system

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.

Governance and quality system standards

Traceability

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.

Traceability standards

Premises, facilities and equipment

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.

Premises, facilities and equipment standards

Classification of the level of shortfall

Where the HTA determines that a licensing standard is not met, the improvements required will be stated and the level of the shortfall will be classified as ‘Critical’, ‘Major’ or ‘Minor’. Where the HTA is not presented with evidence that an establishment meets the requirements of an expected standard, it works on the premise that a lack of evidence indicates a shortfall.

The action an establishment will be required to make following the identification of a shortfall is based on the HTA's assessment of risk of harm and/or a breach of the HT Act or associated Directions.

Shortfall levels

Anatomy Licensing Standards and Guidance

A printable PDF version of this guidance can be downloaded below.