The Royal College of Pathologists recognises common current practice of using anonymised/pseudo-anonymised remnant serum or plasma specimens for the purposes of quality control assessment, reference range adjustment and method evaluation when changing analyser or method. These are essential and frequent uses across all laboratory services within the UK. They are usually carried out without any consent procedures in place, other than those attributed to the original reason for the blood sample being taken.
The Human Tissue Acts of England, Wales and Northern Ireland (2004) and Scotland (2006) do not adequately deal with this use of remnant serum and plasma – both in terms of its explicit definition of what constitutes relevant material (containing even one cell) and how anonymised use for routine performance assessment and quality control should be interpreted under the law.
While the College would support the current use of remnant materials for such uses, given the uncertainty, it needs to be left to local authorities and providers to decide how such practice locally sits alongside the Human Tissue Act and associated ethical guidance. The College would agree that further refinement of the Acts is required to deal with and clarify this situation. Until then, the College would support current use of anonymised/pseudo-anonymised samples for the following purposes, given the need to support ongoing laboratory services. This is not a formal instruction or in any way overrides current and future local/national/legal interpretation:
- Where remnant samples will be used for evaluation or assessment of established diagnostic devices or in-vitro diagnostic kits then destroyed (performance assessment).
- Where remnant samples are used in a programme for systematic monitoring/evaluation of a project, service or facility to ensure that standards of quality are being met (quality assurance).
Author(s)
