Guidance for those responsible for the dignity and care of the deceased
Context
- The HTA’s primary purpose is to regulate organisations that remove, store and use human tissue for purposes including post-mortem examination, education and training, and medical treatment. We operate on a principles-based approach to ensure the safe and trusted use of human tissue, which includes the safety and dignity of the deceased, as derived from the Human Tissue Act (2004).
- One of our guiding principles is that dignity should be paramount in the treatment of human tissue and bodies. This is especially the case in those settings where human bodies are stored. Organisations licensed by the HTA are subject to our requirements and oversight.
- This approach is reinforced by our regulatory framework and these principles can helpfully inform the actions of anyone involved in using materials originating from people.
- For organisations beyond the HTA’s regulatory remit, a similar principles-based approach may be appropriate in their settings when caring for deceased people. Below, the HTA has set out generic best practice principles which may be helpful for those who are responsible for the dignity and care of the deceased.
Leadership
5 Appoint a senior individual with clear responsibility for ensuring suitable and compliant practices are in place. This will include:
a. Suitable policies and procedures to safeguard the security and dignity of deceased people.
b. Appropriate and effective access controls over activities involving human tissue
c. A clear line of accountability within the organisation, for example to the governing body or Board.
Access restrictions and control monitoring
6 Ensure premises are secure to prevent unauthorised access to areas where human tissue is stored or used:
a. Establish and maintain mechanisms to monitor access and control, including who can access areas where deceased people are managed to ensure authorised access for legitimate purposes only; security considerations may include locks, alarms and CCTV.
b. Ensure mechanisms are underpinned by clearly documented policies and procedures to protect against unauthorised access and inappropriate behaviour.
Suitability of premises
7 Ensure premises and facilities protect deceased people — providing safe, secure and clean locations — with systems in place for ongoing monitoring to make sure specifications are maintained:
a. Premises are fit for purpose for the activities being carried out.
b. Facilities are secure with safety measures in place to protect staff and ensure the integrity of tissue and samples.
c. Equipment is appropriate, functions correctly and is maintained as recommended.
Environmental controls
8 Ensure storage areas and facilities are clean, secure, temperature-controlled where necessary, and designed to preserve dignity at all times:
a. Premises are clean and well-maintained to prevent contamination or degradation of human tissue; regular cleaning schedules and audits are in place.
b. The environment is appropriate to undertake activities, as documented, safely; for example, there is proper ventilation and temperature control if required.
c. Facilities are secure, with controlled access to areas where human tissue is stored or used.
d. Appropriate monitoring systems are in place; for example, temperature logs, humidity control and alarms for equipment failure.
Staff and Training
9 Ensure staff appointed to roles, which can include care for deceased people and their tissue, are properly assessed prior to appointment and found suitable against pre-determined criteria.
10 Ensure staff are trained and equipped to communicate clearly, honestly and sensitively, with knowledge on correct procedures, potential risks and the ability to accommodate a range of cultural and religious needs.
11 There should be staff training and induction packages on all policies and procedures relevant to their work.
12 There should be suitable continuing professional development plans to maintain competence and ensure staff are keeping abreast of best practice.
13 There should be clear reporting pathways for staff to raise concerns regarding any behaviours within the facility which could compromise the dignity of the deceased.
Governance arrangements
14 Ensure governance arrangements are strong and are supported by clear and controlled documentation, including:
a. Effective audits to evidence all processes and procedures meet system requirements, identify gaps and support improvement; audits should include security measures and facility access records.
b. Maintained documentation to ensure all processes are reflective of up-to-date policies and procedures via standardised forms.
c. An effective system of risk management with protocols in place to deal with adverse events, for example an incident reporting system to support the management of incidents with clear channels for raising and escalating serious concerns.
Oversight mechanisms
15 Ensure that the care and management of deceased people and their tissue complies with legal, ethical and professional expectations. Oversight mechanisms include:
a. Scheduled internal audits covering security arrangements and procedures relating to dignity.
b. Regular governance meetings where deceased care matters are discussed.
c. Clear escalation routes to senior management and governing bodies.
d. Remaining informed of recommended practices through relevant organisations, such as regulators and professional bodies. This includes providing access to shared learning about the safe and dignified care of deceased people, supporting better practices and processes overall.
16 The HTA Codes of Practice and Standards provide further guidance. Whilst these are specific to activities undertaken within the scope of our remit, other organisations operating within similar settings may find them of use: