Position statement on the biological tests required for autologous donors of tissues and cells

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.