Quality issues in stem cell and immunotherapy laboratories.
The advent of the Code of Practice for Tissue Banks has led to the requirement for quality systems to be established in all laboratories involved in the production or processing of all cellular tissues to be used therapeutically. The quality system is all-encompassing from process validations and quality assurance to the standard of facilities and staff training. This seems self-evident to those working within the transfusion field but is a relatively novel concept to many hospital laboratories preparing transplant products such as bone marrow or peripheral blood derived haematopoietic stem cells. This review places the current guidelines in an historical context and explains many of the central tenets and requirements of the Code of Practice while outlining a process to facilitate preparation for accreditation.
Smith
L
L
Department of Haematology, Royal Free & University College Medical School, London, UK.
Lowdell
M W
MW
D000068:Accreditation; D004780:Environment, Controlled; D004866:Equipment Contamination; D005568:Forms and Records Control; D019983:Guideline Adherence; D017408:Guidelines as Topic; D006801:Humans; D007167:Immunotherapy / Q000592:standards*; D017053:Infection Control / Q000592:standards; D007753:Laboratories / Q000592:standards*; D011785:Quality Assurance, Health Care; D011786:Quality Control; D012308:Risk Management; D033581:Stem Cell Transplantation / Q000592:standards*; D014015:Tissue Banks / Q000592:standards*; D006113:United Kingdom