Fresh frozen material
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The Human Tissue Act (HT Act) makes consent the fundamental principle underpinning the lawful storage and use of human bodies, body parts and tissue from the living or the deceased, for the purposes specified in the HT Act. The consent provisions of the HT Act do not apply, however, if the material has been imported.
Nonetheless, the HTA considers it good practice to ensure mechanisms are in place in the source country for obtaining consent.
- Imported cadaveric material should be obtained, used, handled, stored, transported and disposed of in accordance with the consent which has been obtained. Importers should satisfy themselves that the seeking of consent for the relevant purposes was part of the process by which the material was obtained.
- Imported cadaveric material should be accompanied by a donor sheet, confirming the low-risk status of the donor and including testing results.
- Imported specimens should have been confirmed negative for HIV disease, Hepatitis B, Hepatitis C, Tuberculosis, a transmissible spongiform encephalopathy (such as Creutzfeldt-Jakobs Disease) and Meningitis by the supplier in the source country, and if positive should have been excluded from donation. Donor testing should have been carried out by a licensed or accredited laboratory and the donor information should have been reviewed and signed off before any specimen was considered available for release.
- The DI should assure themselves that all imported specimens were procured, wrapped and shipped in fashion to prevent accidental exposure and should conform to the international standards for the transport of hazardous clinical material. If any specific requests were made by the deceased regarding disposal when consent was obtained, such requests must be carried out. This may include, for example, the return of material to the country of origin.
Establishments should ensure the following:
- Make sure that your establishment is using appropriate procedures and conditions for freezing, thawing and storing frozen bodies and body parts. The processes for preparing and storing bodies and body parts should have been reviewed and ratified by your establishment.
- All staff working on the process should be trained, and familiar, with all aspects of the procedure. Refresher training and competency assessments should be carried out regularly.
- Given the practical and personal challenges of working with this type of material, establishments should ensure that staff have access to advice, guidance and support, both through the organisational structure and independent organisations.
- Ensure that donors who have tested positive for HIV disease, Hepatitis B, Hepatitis C, Tuberculosis, a transmissible spongiform encephalopathy (such as Creutzfeldt-Jakob Disease) and Meningitis have been excluded from donation by the supplier in the source country. Donor testing should have been carried out by a licensed or accredited laboratory and all donor information should have been reviewed and signed off before any specimen is considered available for release.
- Ensure that any material being loaned is covered by an agreement specifying, at a minimum:
- who is responsible for custodianship of the material at every stage
- how and where the material will be used at the receiving establishment,
- storage conditions and the fate of the material after it has been used at the receiving establishment (e.g. sensitive disposal or return to the loaning establishment).
- It is recommended that appropriate staff from the loaning establishment consider visiting the receiving establishment and undertaking a suitability assessment
For additional information, please see ‘Managing Infection Risks when Handling the Deceased’ issued by the HSE in July 2018 which provides further detail on infection risks associated with working with the deceased, and replaces the previous HSE guidance, Safe working and the prevention of infection in the mortuary and post-mortem room (2003) and Controlling the risks of infection at work from human remains (2005).
The person wishing to donate their body should be given all the information necessary to make an informed decision. Consent forms should cover consent for all possible uses of the body. Relatives should also be informed of the possible timeframe in which the body may be used before completion of the donation. They should also be made aware that the decision on what purpose the body will be used for is made at the time of death and the factors that may influence the use.
There is further guidance on improving transparency in the information used to support the seeking of consent for body donation can be found in the HTA Code of Practice C Anatomical Examination and the HTA website here.
If there is the potential for specimens to be used for commercial purposes or exported, the potential donor should be made fully aware of these possibilities and should provide their informed consent.
If there is a potential for specimens to be used for training and education, the establishment should check the qualifications and suitability of the course leaders before permitting a course to take place. They should also check to see if the course reflects the consent that the donor has given.
Risks assessments should include the risks relating to premises, individuals coming into contact with fresh frozen material, practices and procedures connected with licensed activities including:
- Disease transmission to staff or delegates, including those who may be at increased risk (e.g. due to a compromised immune system)
- Dignity of the donors and the cadaveric material
- Storage of cadaveric material and contingency arrangements
- Security of the premises
- Preparing the cadaveric material for courses
- Transportation risks
- Loaning of cadaveric material
- Likelihood of visitors and untrained staff (e.g. students, visitors, maintenance) coming into contact with infected specimens without appropriate supervision
Documented risk assessments should include an evaluation of the level of risk and, where appropriate, the mitigating actions identified and the level of residual risk remaining.
Establishments should make an assessment of the likelihood of disease transmission from fresh frozen bodies or body parts, and take appropriate steps to minimise the risks of disease transmission to individuals handling the material.
We recommend liaison with local Infection Control or Occupational Health services to ensure compliance with organisational policies and national guidelines.
The following are also possible ways to reduce risk:
- Screening living donors (e.g. tests or lifestyle questionnaires)
- Checking test results on material or associated donors, confirming low-risk infection status
- Confirming the serostatus of donations prior to acceptance
- Ensuring that testing was carried out by an accredited/licensed laboratory
- Ensuring appropriate ventilation in storage and training areas
- Checking the immunisation status of delegates before contact with bodies or body parts
- Training for individuals in SOPs relating to bodies/body parts
- Ensuring appropriate PPE is available
- Appropriate conditions for the transport of material
- Appropriate storage conditions, cleaning and decontamination
- Management and supervision of course delegates using material