During this period, it is likely that Human Application establishments will have to adapt quickly to changing circumstances, whether as a result of staffing or supply chain issues.
Establishments should carefully review their contingency arrangements for staff, equipment and consumables that are critical to the conduct licensable activities.
We anticipate that many establishments will be affected by staff shortages. As a result, new staff or staff from other departments may be required to ensure that services can continue to be delivered. In these circumstances, it is important to ensure that all members of staff carrying out licensable activities are adequately trained and that their training is documented.
Incident recording and reporting
Establishments should maintain oversight of incidents, and ensure that all serious adverse events and reactions (SAEARs) continue to be reported to the HTA within 24 hours whenever possible. Establishments should consider who is best placed to report SAEARs to the HTA and review whether there is sufficient cover to report incidents in the event of staff absences.
Consideration should be given to registering more people on the HTA’s portal for SAEARs reporting.
Supplies of critical consumables and reagents
The pandemic may cause supply chain issues for materials and reagents that are used for licensable activities. Consumables can be replaced with equivalent products without the requirement to submit an updated Preparation Process Dossier (PPD) for assessment. The HTA defines equivalent products as ones with similar constituents or composition, the use of which is unlikely to impact significantly on the quality and safety of the tissues and cells.
Any such changes should be managed under a formal change control procedure which considers factors such as the need to amend standard operating procedures, the need for staff training and any impact the change may have on the processing environment.
Establishments are asked to notify the HTA if supply chain issues become apparent or if they need advice about the substitution of materials and reagents.
New processing procedures and changes to existing preparation processes
At this time, establishments may need to introduce new processing procedures at pace. Processes used to prepare tissues or cells for human application must be validated to ensure that they do not render the samples clinically ineffective or unsafe and this remains the case during this period.
If you need to introduce a new processing procedure, or if you need to make a significant change to an authorised process, please contact the HTA as soon as possible so that we can advise you on whether any information should be submitted to the HTA.
Establishments do not need to contact the HTA if only minor amendments to preparation processes are being made. Further information can be found in our PPD guidance.
Changes to licensable activities under a Human Application licence
Human Application sector establishments must ensure that they remain compliant with the licensing requirements of the Human Tissue (Quality and Safety for Human Application) Regulations 2007. Licensable activities carried out by third parties on behalf of an establishment must continue to follow the requirements set out in the HTA Guide to Quality and Safety Assurance of Human Tissues and Cells for Patient Treatment. Establishments must continue to seek approval from the HTA prior to conducting new licensable activities or commencing work with a new tissue type.
The HTA will take steps to expedite the approval process where there is an urgent clinical need for a licence variation. For more information, please see our Key information for DIs page.
HA licence fee invoices
We have taken the decision to defer presenting the Annual Licence Fees invoices that would normally have been issued in April to late September for Human Application sector establishments.
What this means is that invoices will be issued using the Purchase Order numbers we have received from you. On issuance of the invoice in September, the usual payment terms will apply. Please contact us at email@example.com if you have any questions or concerns.
Donor selection and exclusion
The Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC) is publishing regular updates to its donor selection guidelines in response to the COVID-19 pandemic. The HTA expects establishments to follow JPAC guidelines when making decisions about donor selection.
Both JPAC and the HTA’s Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment include provision for donors to be accepted on the basis of a documented risk assessment.
Under normal circumstances, the HTA would expect individual risk assessments to be approved by the DI. At present this may not be feasible. If establishments are unable to meet this requirement, they should have a documented procedure in place that sets out how risk assessments will be conducted, and by whom. The procedure should be approved by the DI and clearly set out who is authorised to approve individual risk assessments on their behalf.
The European Centre for Disease Control has issued further guidance on the supply of substances of human origin during the COVID-19 pandemic.