Future Health Biobank - HTA Inspection Summary Report

Over our 18-year history, we have become the UK’s largest and most experienced cord blood bank, storing more stem cell samples than all other UK banks combined. We are passionate about protecting your family’s health, whilst staying at the forefront of present and future innovations. We are the most accredited cord blood bank in the UK and are licenced by the Human Tissue Authority (HTA) for the procurement, testing, processing, storage, distribution, import and export of a variety of sample types for human application. The following report provides an explanation of the findings of our HTA inspection performed in September 2019.

The HTA is an executive non-departmental public body of the Department of Health and Social Care in the United Kingdom. The HTA regulates the removal, storage, use and disposal of human bodies, organs and tissue for a number of scheduled purposes such as research, transplantation, education and training.

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.

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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

HTA Classification:

Customer Impact: None

FINDING – The documented procedures did not adequately detail processes required for the routine execution of licensable activities. Click HERE to read full finding

WHAT THIS MEANS – Documentation based finding. During the inspection, an operator’s protective suit was splashed with a small amount of blood from a waste portion of a sample being processed. The operator completed processing of this sample and was provided a clean suit as per our sterility and training procedure. However, this procedure was not specifically written into our operating procedure.

IMPLEMENTATION – Update to procedure to include practice of changing ‘contaminated’ garments within our operating procedures.

Completion Date: November 2019 – COMPLETED


HTA Classification:

Customer Impact: None

FINDING – While many processes undergo audit and assessment, the internal audit system does not cover all licensable activities. Click HERE to read full finding

WHAT THIS MEANS – Documentation based finding. All procedures are currently performed; however, improvements could be made to the written procedures to simplify the process currently covered by multiple documents

IMPLEMENTATION – Update file checking and release for storage procedures to ensure review of all licensed activities. Client file audit procedure to encompass samples which have completed the full ‘release for storage’ procedure will ensure that records resulting from all licensable activities are routinely evaluated without duplication.

Expected Completion Date: February 2020


HTA Classification:

Customer Impact: None

FINDING – While the establishment has plans to implement a six-monthly evaluation of cryopreserved tissue, these plans have not yet been finalised. Click HERE to read full finding

WHAT THIS MEANS – Our validation was completed in February 2019 which provided an evaluation of cryopreserved tissue. HTA standards state this this needs to be repeated routinely to ensure that the same processes continue to achieve the same results. FHT chose to implement 6 monthly testing but had not yet implemented this time frame. Routine re-evaluation will be performed in January 2020 and six-monthly thereafter.

IMPLEMENTATION – Implementation of biannual quality control testing of dental pulp and cord tissue samples.

Completion Date: January 2020 – COMPLETED


HTA Classification:

Customer Impact: None

FINDING – There was no evidence of risk assessments being carried out to decide the fate of any tissue and / or cells stored prior to the introduction of a new donor selection criteria or a new processing step, which enhances the quality and safety of tissue and / or cells. Click HERE to read full finding

WHAT THIS MEANS – Documentation based finding. Our current change request procedure already includes a risk-assessment section that determines any impact on the sample prior to any changes being made to our procedures, however the HTA felt this should be more extensive moving forward.

IMPLEMENTATION – Update to change request procedure to expand the current risk assessment section so that where risks are identified resulting from the change, a review of the entire process Quality Risk Assessments will be also be documented prior to the approval of the change.

Expected Completion Date: February 2020


HTA Classification:

Customer Impact: None

FINDING -The Medical Director reviews the mother’s medical history questionnaire and related tissue/cell documentation to ensure that the standards laid down by Directions 003/2010 have been met, and to authorise the final product as suitable for eventual release. A review of the product database identified significant numbers of samples from January 2018 onwards that had not been reviewed in line with establishment procedures.

WHAT THIS MEANS – Documentation based finding. A spreadsheet was created during the inspection of all medical comments added to client records. The Medical Director reviews all positive medical history questionnaires. However, additional comments are added by the Administration department to the client record if for example, there is travel to countries at risk of infectious diseases. Where the client has no symptoms of infection, the requirement for this testing does not impact storage or future use, as such these were not sent to the Medical Director for review and as such are considered by the HTA as being still pending review.

IMPLEMENTATION – Perform review and approval of all samples on the above medical comment spreadsheet. Update donor eligibility procedure for new samples received which clearly defines which responses require medical evaluation and which, such as travel, do not.

Expected Completion Date: March 2020


HTA Classification:

Customer Impact: None

FINDING -The establishment currently stores tissues/cells for a maximum 20 or 25 years before discussing their continued storage with the donor. However, these maximum storage periods, and the evidence supporting their use, are not adequately captured in the establishment’s governance documentation.

WHAT THIS MEANS – Documentation based finding. The storage time is clearly defined in our Parent Storage Agreement, this finding relates to internal documentation.

IMPLEMENTATION – Update Processing and Storage Policy to include justification of the maximum storage period which is based on published scientific data.

Completion Date: January 2020 – COMPLETED


HTA Classification:

Customer Impact: None

FINDING-FHT’s authorised Preparation Process Dossiers (PPDs) set out that tissues/cells will be transported within specified temperature ranges and time periods. A review of transit data from February 2019 onwards identified a significant number of records indicating that samples may not have been transported in line with these requirements. These potential non-conformances had not been identified by the establishment. Click HERE to read full finding.

WHAT THIS MEANS – Documentation based finding. All licensed facilities submit PPDs for approval by the HTA to demonstrate that the procedures utilised for the processing of cells and tissues do not render the samples useless or unsafe. As part of our PPD, we provided data from validation samples to define our accepted transport conditions which was approved by the HTA. However, in some cases samples fell outside of the transport requirements we had specified and were not documented adequately, of all of these cases only one sample did not meet the success criteria for storage though this could be due to many other more prominent factors which affect success. The HTA do not expect for an establishment to never have non-conformances, however they do require notification and documentation to be clear and timely, this is where improvements are required.

IMPLEMENTATION – FHT has committed to introduce a fully automated procedure for analysis of transport data to identify samples shipped outside of temperature immediately upon arrival. HTA reporting procedures will be updated to include instructions for notifying the HTA of samples transported outside of the validated temperature range which are deemed unsuitable for storage. Clients will also be informed if their sample is transported outside of validated time/temperature criteria.

Expected Completion Date: January 2020


HTA Classification:

Customer Impact: None

FINDING-FHT’s authorised PPDs set out that samples received outside of the validated ranges for time and temperature in transit would be subjected to additional quality control checks, including the ability of the cells to differentiate into certain lineages. Click HERE to read full finding

WHAT THIS MEANS – Documentation based finding. We perform quality control testing on every sample to ensure that all stored samples contain viable cells. As part of the PPD submitted to the HTA we intended to perform additional testing on samples received outside of this validated range. However, following our extensive validation work we had actually already demonstrated that if a sample contains viable cells, these cells are always capable of becoming the additional cell types useful in medical application for all samples rather than just those that did not meet the guidelines. As such, our quality control testing is sufficient to identify samples which do not contain viable cells and clients are already notified of this. However, this finding was raised as we did not notify the HTA of the change made to this process prior to the inspection.

IMPLEMENTATION – Our testing procedure is adequate, documentation must be updated to match this process and detail that if a sample is transported outside of validated range, clients will be notified of the transport conditions along with their sample results.

Expected Completion Date: January 2020


HTA Classification:

Customer Impact: None

FINDING – The establishment’s authorised PPD for dental pulp (DP) specified the use of a particular type of transport container (NanoCoolTM). At the time of the inspection, the establishment was not using this container. Click HERE to read full finding

WHAT THIS MEANS – NanoCoolTM was implemented for use in transporting cord blood and cord tissue, however the implementation of this kit worldwide was delayed for dental pulp samples and was therefore not in place in time for the 2019 inspection. However, we have since implemented the NanoCoolTM kit for our dental pulp samples in order to comply with the PPD submitted to the HTA.

IMPLEMENTATION – Implementation of specialist dental pulp kit containing activated cooling system. This was actioned immediately and all dental pulp kits sent out since September 2019 include the NanCoolTm system.

Completion Date: September 2019 – COMPLETED


To read the report in full please click here

If you have any questions about our services please contact our Customer Care team