Issued 17 August 2009
It is a requirement of the Human Tissue (Quality and Safety for Human Application) Regulations 2007 that autologous donor serum testing is performed when removed tissues or cells are stored*. The reason for this requirement is to reduce the risk of contamination and transmission of disease through mislabelling or misidentification of tissues or cells. The following mandatory laboratory tests must be performed: Human Immunodeficiency Virus (HIV) 1 & 2, Hepatitis B (core and surface antigen), Hepatitis C and Syphilis.
A number of Designated Individuals previously expressed concern about the nature of the serum tests and implications of a positive result in certain patient groups (children, elderly and unconscious patients). In July 2007 the HTA took the position not to penalise establishments that chose not to test low risk patients, provided the decision had been made following a robust risk assessment and appropriate quarantine arrangements were in place. However, the HTA became aware of inconsistencies between establishments when considering which patients were low risk and therefore excluded from testing. As a consequence, the HTA have carried out a policy review considering the requirement for laboratory testing of autologous donors in two specific scenarios, set out below.
When a patient is competent to consent to donor serum testing but the clinician deems it inappropriate to ask for consent
Clinicians must always ask competent patients to consent for all biological tests required for autologous living donors if tissues / cells are to be stored*. This applies to all patients, even those considered to be at low risk of infection. In the case of children, the clinician should gain consent from a person with parental responsibility for the child.
When a patient is not competent to consent to donor serum testing
If a patient is unable to consent for treatment that involves the removal and storage* of tissues / cells then treatment will be considered to be in the patient's best interests and will be carried out without consent. By the same principle, mandatory biological serum tests should also be carried out in the patient's best interests. This is a requirement in order to permit tissue storage* and to ensure that patients that are unable to consent are provided the same level of protection as competent patients.
This position statement replaces any previous position statement or communication issued by the HTA regarding the biological tests required for autologous donors of tissues and cells.
* "Storage" means maintaining tissues or cells, whether by preservation or in any other way, for more than 48 hours, and "store" is to be interpreted accordingly (The Human Tissue (Quality and Safety for Human Application) Regulations 2007, Regulation 5 (1))