HTA Anatomical Examination Quality Manual, SOPs & Risk Assessments
Quality Manual
The purpose of the Quality Manual is to document the University’s Quality Management System (QMS) for the governance of the acquisition, storage, use and disposal of human samples for anatomical examination and for education or training relating to human health to ensure that all staff and students understand the necessary requirements and procedures covered by the Human Tissue Act, 2004, the Human Tissue Authority’s (HTA) Codes of Practice and the University’s HTA Licence for anatomical examination. It should be read in conjunction with the latest versions of the Standard Operating Procedures (SOPs) which can be found on this page.
See: Quality Manual
Standard Operating Procedures
As part of the Quality Management System (QMS) governing all anatomical examination by staff and students, a number of Standard Operating Procedures (SOPs) have been developed, detailing polices and instructions on all the processes that affect the quality and safety of human samples used in anatomical examination.
The SOPs provide a uniform approach to the performance of specific functions to ensure continuity and consistency across the University. They have been produced in line with the relevant HTA’s Codes of Practice and Standards and should be read in conjunction with them. They will be regularly reviewed and updated as required.
Please ensure that you are working to the latest version of each SOP and that out-of-date versions and copies are destroyed.
|
SOP/Risk Assessment |
No. |
Version |
Approved: |
|
SOP - Standard Operating Procedures |
HTA SOP 1 |
V 1 |
May 2024 |
|
SOP - Definitions |
HTA SOP 2 |
V 1 |
May 2024 |
|
SOP - Material Transfer Agreements |
HTA SOP 3 |
V 1 |
May 2024 |
|
SOP - Human Specimens Handling and Security |
HTA SOP 4 |
V 1-2 |
Nov 2024 |
|
SOP - Adverse Events |
HTA SOP 5 |
V 1 - 2 |
Oct 2024 |
|
SOP- Audit |
HTA SOP 6 |
V 1 - 2 |
Oct 2024 |
|
SOP - Training |
HTA SOP 7 |
V 1 - 2 |
Oct 2024 |
| SOP - Storage | HTA SOP 8 | V 1 - 2 | Oct 2024 |
|
SOP - Transport |
HTA SOP 9 |
V 1 |
May 2024 |
| SOP - Disposal | HTA SOP 10 | V1 | May 2024 |
| SOP - Facility Access | HTA SOP 11 | V 1 - 2 | Oct 2024 |
| SOP - Cleaning | HTA SOP 12 | V 1 - 2 | Oct 2024 |
| SOP - Beehive Major Incident PlanLink opens in a new window | HTA SOP 13 | V1 | Oct 2024 |
|
HTA RA3 |
V3 |
May 2024 |
|
|
Risk Assessment - Anatomical Examination ActivitiesLink opens in a new window |
HTA RA2 |
V2 |
May 2024 |
|
Risk Assessment - Anatomical Specimens and Anatomy CentreLink opens in a new window |
HTA RA1 |
V2 |
May 2024 |
Risk Assessments
Risk assessments have been carried out by the DI (Anatomy) and are regularly reviewed. Current risk assessments are shown in the table above and a sign-off form (see below) must be completed.
SOP and risk assessment sign-off
As a requirement for the registration of all staff and students undertaking research involving the use of human samples, individuals must update the training record to confirm that he/she has:
- read the SOPs and risk assessments relevant to their role;
- understood how to apply the SOPs and risk assessments to their work;
- know where to locate a copy of the current SOPs and risk assessments.