We recently had an inspection from the Human Tissue Authority (HTA) to monitor our compliance with the tissue and cells directive. The HTA found Biovault to be working in accordance with the requirements of the legislation.
Since 5 July 2008, the HTA has regulated the collection, testing, processing, storage, distribution, import and export of cord blood. In the UK these are ‘licensable activities’ and can only lawfully take place under an HTA licence. Further information on HTA licensing can be found here.
Within their report they left some really positive feedback on a number of strengths and areas of good practice observed during their inspection;
- There is a high level of staff investment evident through promotion of staff and support for staff to attend external courses.
- Training of staff in-house is good with a system of initial training and reassessment of competence at regular intervals. An online survey is used to check staff understanding of new or revised SOPs.
- Biovault has a good quality management system in place. Companies that supply goods from outside the EU are audited regularly using comprehensive questionnaires that require the provision of sample copies of primary records to Biovault.
- The establishment has also sought and received accreditation from a number of external bodies, such as Joint Accreditation Committee-ISCT (Europe) & EBMT (JACIE), and also holds ISO 9001 and ISO 13485 accreditation for its quality management systems.
- The establishment also participates in the UK National External Quality Assessment Service (NEQAS) scheme to help ensure that the results of laboratory tests carried out in-house continue to be reliable.
If you would like to read the full HTA report click here.
To see how we rank against our competitors click here.