To fulfil its statutory responsibilities, the HTA must be able to assess whether an organisation is suitable to carry out the activities for which they are licenced. For companies in the human application sector, including Future Health Biobank, the HTA conducts a site inspection every two years to check the regulatory standards are being met. These standards are mandatory for all licenced organisations and cover four broad themes; consent, governance and quality systems, premises, facilities and equipment and disposal.
The focus during a site inspection is to review operational policies and procedures, inspect premises and interview a range of staff. This allows the HTA to identify any shortfalls in relation to the standards and confirm that the HTA is satisfied with the suitability of a company to carry out these activities, in our case we have over 118 standards to meet. Where a standard is not met, the HTA will identify the shortfall and report the level of significance as a critical, major or minor. The organisation is required to produce a corrective and preventative action plan which details how and when they will address the finding, with the urgency relating to the severity of the finding. Given the medical nature of the work undertaken by stem cell banks, it is typical during inspection of every cord blood bank within the UK that some major and minor shortfalls will be found though a critical finding would be of great concern. This is due to the stringent procedures required to ensure that samples are safe to use. If the HTA considers that a shortfall poses a direct risk of causing harm to a patient or there are a number of ‘major’ shortfalls which cumulatively represent a systemic failure, this could result in the organisation losing their HTA licence. In our 18-year history, Future Health has never received a critical finding during any of our inspections.
Future Health Biobank are the only private cord blood bank to perform quality control testing of every sample received in order to ensure that all of our client’s samples contain viable cells at the point of use. The improvement actions to our auditing and client reporting procedures in response to these inspection findings will further strengthen our current ethical and transparent practices by ensuring that our clients are advised of all information relating to their sample which already exceeds the standards expected by the HTA and will ensure consideration of all aspects of processing are correctly documented and routinely reviewed to confirm that written procedures reflect the justification and scientific evidence of all processes performed by Future Health Biobank.
We support the publication of inspection reports on the HTA website which aligns with our ethos of openness and honesty for our clients. Once all findings are addressed, the HTA will update our report accordingly. In addition to our HTA inspections, we are regulated by the Human Fertility and Embryology Authority (HFEA), Medicines and Healthcare products Regulatory Agency (MHRA) and voluntarily certified by the AABB and British Standards Institute (BSI) which means that all aspects of our services are inspected on average, every 4 months to ensure that we continue to improve and expand the quality of the services offered to our clients.2
Summary of HTA inspection September 2019
The HTA findings from our latest inspection are detailed below, along with the effect on our client’s samples and the corrective actions we are making to address each one. The majority of the findings are focused on documentation of procedures and issues rather than our physical actions, the HTA require updates to our quality management system so that our written protocols reflect accurately the procedures we already have in place.
Licensed activities: • Distribution • Export • Import • Processing • Procurement • Storage • Storage of Relevant Material • Testing
Standards reviewed by the HTA
118 Standards assessed