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Quality and Regulatory Compliance

 

Quality and Regulatory Compliance


The Human Tissue Act 2004, the Human Tissue Regulations 2007 and associated Codes of Practice have all now transposed the European Union Tissue and Cells Directive (EUTCD) into UK law. The Anthony Nolan Cord Blood Programme holds a license from the Human Tissue Authority which you can download here. This proves we comply with all of the requirements of this regulatory body. A major feature of the Human Tissue Act is that it makes consent the fundamental principle for the lawful removal, storage and use of human tissue (umbilical cord blood is classed as a tissue by the HTA). The Human Tissue Authority have issued Codes of Practice which detail recommendations in these areas. We implicitly incorporate many Good Manufacturing Practices (GMP) to further enhance the quality and safety of our products.

The Anthony Nolan Cord Blood Programme is also working towards the internationally renowned NetCord-FACT accreditation. The mission of NetCord is to promote high quality cord blood banking and clinical use of umbilical cord blood for allogeneic stem cell transplantation. FACT was founded in 1996 by its two parent organisations, the American Society for Blood and Marrow Transplantation (ASBMT) and the International Society for Cellular Therapy (ISCT). FACT promotes quality medical and laboratory practice of cellular therapy through its peer-developed standards, and voluntary inspection and accreditation programme.

In terms of research cord distribution, we have obtained the necessary generic ethics approval to gain status as a recognised research tissue bank. We’ve done this through a UK Research Ethics Committee. It allows us to potentially provide processed umbilical cord bloods to external researchers without them needing to additionally apply to a REC for ethics approval for their project.

The Quality Policy of the Anthony Nolan Cord Blood Bank


The Anthony Nolan Cord Blood Bank (ANCBB) Programme is committed to providing a service of the highest quality and shall be aware and take into consideration the needs and requirements of its users.

In order to ensure that the needs and requirements of users are met, the ANCBB will:

  • Operate a quality management system to integrate the organisation, procedures, processes and resources.

  • Set quality objectives and plans in order to implement this quality policy.

  • Ensure that all personnel are familiar with this quality policy to ensure user satisfaction.

  • Commit to the health, safety and welfare, of all its staff, donors and recipients. Visitors to the facility will be treated with respect and due consideration will be given to their safety while on site.

  • Commit to comply with environmental legislation.

  • Uphold professional values and be committed to good professional practice and conduct.

The ANCBB will comply with the standards set by the HTA and work towards those set by NetCord-FACT. It is committed to:

  • Staff recruitment, training, development and retention at all levels to provide a full and effective service to its users.

  • The proper procurement and maintenance of such equipment and other resources as needed for the provision of the service.

  • Correct performance of all clinical products via the routs of procurement, production and distribution.

  • The use of production procedures that will ensure the highest achievable quality of all tests performed.

  • Reporting results of examinations in ways which are timely, confidential, accurate and clinically useful.

  • The assessment of user satisfaction, in addition to internal audit and external proficiency testing, in order to produce continual quality improvement.

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