This guidance helps licensed establishments to meet the HTA’s post-mortem licensing standards.
The guidance covers guidance on consent, governance, premises, including security and traceability.
It also contains additional information and examples of how to meet certain standard
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 post-mortem 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.
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.
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.
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. The governance and quality systems standards govern the practices taking place on licensed premises, and ensure that they preserve the dignity of the deceased and that the deceased are treated with respect.
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. The governance and quality systems standards govern the practices taking place on licensed premises, and ensure that they preserve the dignity of the deceased and that the deceased are treated with respect.
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 the HTA expects 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.
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 the HTA expects 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.
Establishments meeting these standards will be able to demonstrate that their premises and facilities are appropriate for the licensed activities taking place, that they are safe, secure and clean and that there are effective contingency arrangements in place. In addition, establishments will have systems for ongoing 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 or a risk to bodies.
Establishments meeting these standards will be able to demonstrate that their premises and facilities are appropriate for the licensed activities taking place, that they are safe, secure and clean and that there are effective contingency arrangements in place. In addition, establishments will have systems for ongoing 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 or a risk to bodies.
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.
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.
A printable PDF version of this guidance can be downloaded below.