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Quality issues in stem cell and immunotherapy laboratories.

L Smith1, M W Lowdell

  • 1Department of Haematology, Royal Free & University College Medical School, London, UK.

Transfusion Medicine (Oxford, England)
|December 5, 2003
PubMed
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New quality system requirements are mandated for laboratories processing therapeutic cellular tissues, impacting transplant product preparation. This review details the Code of Practice guidelines and accreditation preparation for tissue banks.

Area of Science:

  • Cellular therapy
  • Tissue banking
  • Transplant medicine

Background:

  • The Code of Practice for Tissue Banks mandates quality systems for therapeutic cellular tissue processing.
  • Quality systems encompass process validation, quality assurance, facility standards, and staff training.
  • This is a novel concept for many hospital laboratories preparing transplant products like hematopoietic stem cells.

Purpose of the Study:

  • To provide an historical context for current tissue banking guidelines.
  • To explain the central tenets and requirements of the Code of Practice.
  • To outline a process for facilitating accreditation preparation.

Main Methods:

  • Historical review of guidelines.
  • Explanation of Code of Practice requirements.

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  • Process outlining for accreditation.

    • Main Results:

    • Establishment of quality systems is now a requirement for therapeutic cellular tissue processing.
    • Comprehensive quality management is essential, covering all aspects from validation to training.
    • A structured approach to accreditation preparation is outlined.

    Conclusions:

    • Laboratories processing cellular tissues for therapeutic use must implement robust quality systems.
    • Understanding and adhering to the Code of Practice is crucial for compliance and patient safety.
    • The review facilitates preparation for accreditation, ensuring high standards in tissue banking.