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Cell lines that are European Union Tissue and Cells Directive (EUTCD) compliant should be stored separately from those that are not to avoid any potential contamination issues.
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:
The Designated Individual (DI) of the licensed establishment is responsible for assessment and documentation of the adverse incident occurring under the licence, and reporting of any serious adverse event or reaction to the HTA and any other affected establishments.
The DI should:
In most cases it is illegal to carry out DNA testing, including paternity testing, without consent. Members of the public should contact the police if they suspect the law has been broken.
The requirements and procedures for reporting adverse events and reactions that occur at third parties should be clearly documented.
If you are suffering from a disease or condition, you may be asked by the person treating you if you would like to donate tissue after your death. If you would like to donate and have not been approached, you could ask your treating physician.
The HTA has issued a Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatments as implemented by Directions (Directions 003/2010) setting the standards for third party agreements.
The HTA will assess whether an establishment can meet a number of licensing Standards. These were developed in consultation with representatives from the Public Display sector. These relate to the consent provisions of the Human Tissue Act 2004 (HT Act), governance and quality systems,...
An HTA licence for research is granted to an organisation if it shows it complies with standards set down by the HTA.