Internal audits of Schools/research projects are undertaken to confirm that the area concerned is adhering to the University's Procedures and is compliant with HTA requirements and regulations. Audits are undertaken by the Human Tissue Act Compliance Team together with a PD from another School/Unit. Non-compliance issues will be brought to the attention of the person responsible, and will be recorded, documented and subject to timely corrective action to ensure full rectification.
The audit programme operates on a two-year cycle. In the first year there is a face to face physical audit; in the second year a paper based audit return is made. A copy of the audit checklist can be found at the top right of this page.
Face to Face Audit
The face to face audit schedule comprises a records audit, to ensure records are accurate, complete and legible; a process audit to ensure staff are adhering to SOPs; and a traceability audit to ensure that the establishment can trace specimens from donors consent, or point of receipt if supplied by a third party, to storage, use or disposal. Following the inspection, a report is produced highlighting any issues that need to be addressed to ensure compliance with the HTA Licence. Evidence that these have been addressed will be followed up within 3 months of the audit and during the paper based audit the following year.
Once a School/Unit has had a face to face audit, the second year in the audit process is a paper based audit return. If this identifies any areas of concern, an inspection visit will be made. Should particular needs be identified, the frequency of audit may be increased at the discretion of the Human Tissue Act Compliance Team.
For Further information see Cardiff University HTA Standard Operating Procedure for Internal Audit.