Module Details

Module Code: BIOM8010
Title: QMS for Medical Scientists
Long Title: Quality Management Systems
NFQ Level: Advanced
Valid From: Semester 1 - 2021/22 ( September 2021 )
Duration: 1 Semester
Credits: 5
Field of Study: 7200 - Health Care
Module Delivered in: 1 programme(s)
Module Description: This module introdues the learner to the concept of quality management for the medical laboratory including accreditation to ISO15189. It subsequently translates those concepts into the practical tools of a quality management system.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Relate the principles of quality management applied using ISO15189 to laboratory activities such as sample acceptance and rejection criteria; validation of reagents, equipment & QC materials; sample management and risk assessment.
LO2 Appraise how a QMS, clinical governance and relevant legislation apply to the medical laboratory and the interactions with service users.
LO3 Relate the significance of confidentiality, data protection and freedom of information in dealings with all service users in professional practice.
LO4 Evaluate current quality management tools and their applications in service delivery.
LO5 Defend the impact of personal values and life experience on professional practice and the need to manage this impact appropriately.
Dependencies
Module Recommendations

This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
No incompatible modules listed
Co-requisite Modules
No Co-requisite modules listed
Requirements

This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
No requirements listed
 
Indicative Content
Quality Management System
How quality assurance and quality management aim to optimise quality in the medical laboratory.
Document preparation and control
How standard operating procedures and other documents are derived and controlled.
Operational matters in the laboratory
How to control medical laboratory testing. How to maintain laboratory equipment effectively. How to manage quality and technical records. Determination of effective sampling when conducting quality control of consumables and products.
Internal and External Quality Control. Internal audits
The need for external assessment and accreditation. Continuous improvement: the role of internal audits. How to deal with non conformances.
Service users
Understanding the patient journey. How to communicate effectively with the service user. Understanding the need for different levels of access to reports by service users. How to report results. How to deal with complaints.
Personnel
Employee structures in the medical laboratory. How the chain of command operates effectively. Personnel management to maximise quality in the laboratory. Continuous professional development. Conflict management.
Problem Solving Techniques
Description of the main problem-solving techniques used currently. Use of quality management games and exercises to develop problem solving skills and effective communication.
Suppliers
How to rate the supplier. Understanding the factors that determine the effective procurement of equipment and consumables.
Lean Management
The adoption of lean principles in laboratory management in a continuous improvement cycle.
Module Content & Assessment
Assessment Breakdown%
Coursework40.00%
End of Module Formal Examination60.00%

Assessments

Coursework
Assessment Type Short Answer Questions % of Total Mark 20
Timing Week 7 Learning Outcomes 1,2,3
Assessment Description
Theory examination
Assessment Type Essay % of Total Mark 20
Timing Week 9 Learning Outcomes 2,3,5
Assessment Description
The role of quality in laboratory medicine
End of Module Formal Examination
Assessment Type Formal Exam % of Total Mark 60
Timing End-of-Semester Learning Outcomes 1,2,3,4,5
Assessment Description
End-of-Semester Final Examination
Reassessment Requirement
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.

The University reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Quality Management Systems Every Week 3.00 3
Independent & Directed Learning (Non-contact) Non Contact Self-study Every Week 4.00 4
Total Hours 7.00
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
This module has no Part Time workload.
 
Module Resources
Recommended Book Resources
  • D. Burnett. (2013), A Practical Guide to ISO15189 in Laboratory Medicine, ACB Ventures Publication [ISBN:0902429396], Kent, UK, p.380, [ISBN: 9780902429499].
Supplementary Book Resources
  • Stratton, Laposata. (2011), Clinical Microbiology, Quality in Laboratory Diagnosis, E book, Demos Medical Publishing, [ISBN: 9781617050480].
  • K. Shridhara Bhat. (2010), Total Quality Management, E Book, Himilaya Publishing House, [ISBN: 9788178662527].
This module does not have any article/paper resources
This module does not have any other resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_SBISC_8 Bachelor of Science (Honours) in Biomedical Science 7 Mandatory