| Unit name | Research and Laboratory Management (TTS-D2) |
|---|---|
| Unit code | PANMM0021 |
| Credit points | 10 |
| Level of study | M/7 |
| Teaching block(s) |
Teaching Block 2 (weeks 13 - 24) |
| Unit director | Dr. Nicola Anderson |
| Open unit status | Not open |
| Pre-requisites |
None |
| Co-requisites |
None |
| School/department | School of Cellular and Molecular Medicine |
| Faculty | Faculty of Life Sciences |
This Unit provides an understanding of the manager’s role in maintaining a quality system in a blood bank or blood establishment, how this is applied and its role in accreditation and licencing purposes.
Students will have an overview of how different regulatory frameworks, standards accreditations (such as JACIE and ISO15189) and external quality assessment schemes interact within an overarching concept of quality.
Core areas covered will include the role of the Medicines & Healthcare products
Regulatory Agency (MHRA) and the inspection process, key areas covered such as validation, deviations, recalls, maintenance of the cold chain and IT systems will be discussed in depth with students developing solutions to various scenarios. Major deficiencies reported by MHRA inspections will be discussed.
The inclusion of subjects such as validation allow exploration of implementation of change within a blood centre.
The unit will also cover clinical audit as this feeds into quality and any new UK developments in the structure and management of blood transfusion services.
The second part of the unit covers the process of research, writing a grant application, ethics, governance and the actual management of a project.
Upon completion of the Unit students should have;
Should be able to
5. Discuss the role of regulation and accreditation in maintaining quality.
6. Apply the principles of quality/change to novel situations
7. Explain the key areas of quality and deal with complex scenarios systematically and creatively.
8. Explain the process of clinical audit
9. Demonstrate an understanding of the key principles in setting up a research project
10.Show originality in the discussion and synthesis of information
11. Communicate clearly using appropriate writing styles
12.Demonstrate independent learning ability following lectures and tutorials
13.Demonstrate use of the library, internet and other educational tools
14.Demonstrate the use of standard computer “Office” tools.
The above are assessed as follows;
Assignment 1, 2, 3, 7, 10, 11, 12, 13, 14
Class activities 5, 6, 7, 8
Evidence of 4, 8 and 9 (where appropriate) is assessed in the research project Unit PANMM0005
Lectures and class activities
One written assignment related to change management in transfusion and transplantation services (100%)
www.gov.uk/blood-authorisations-and-safety-reporting (MHRA)
www.ukneqas.org.uk/
www.bcshguidelines.com/documents/Guidelines_for_validation_bcsh_13082010.pdf
http://www.transfusionguidelines.org.uk/red-book/chapter-2-quality-in-blood-and-tissue-establishments-and-hospital-blood-banks
Quality issues, John barker and Joan Jones chapter 12 in Transfusion & Transplantation Science ed R Knight, Oxford University Press.
