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Unit information: Research and Laboratory Management (TTS-D2) in 2017/18

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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

Description

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.

Intended learning outcomes

Upon completion of the Unit students should have;

  1. A broad and in depth understanding of quality and regulatory compliance with blood banks and blood establishments.
  2. A critical awareness of the main framework of a regulatory inspection.
  3. An understanding of change implementation in a large organisation
  4. Knowledge of the processes of setting up and managing a research project

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

Teaching details

Lectures and class activities

Assessment Details

One written assignment related to change management in transfusion and transplantation services (100%)

Reading and References

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.

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