LQN201 Lab Management, Compliance and Quality Control
To view more information for this unit, select Unit Outline from the list below. Please note the teaching period for which the Unit Outline is relevant.
| Unit code: | LQN201 |
|---|---|
| Credit points: | 12 |
| Timetable | Details in HiQ, if available |
| Availabilities |
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| Domestic tuition unit fee | $3,744 |
| International unit fee | $5,148 |
Unit Outline: Semester 1 2025, Online
| Unit code: | LQN201 |
|---|---|
| Credit points: | 12 |
| Coordinator: | Robert Smith | r157.smith@qut.edu.au |
Overview
All aspects of laboratory management are examined including, compliance, accreditation, regulation, safety and quality control. This unit covers governance practices required for genomic scientists and clinicians working in laboratory senior positions.
Learning Outcomes
On successful completion of this unit you will be able to:
- Critique the regulation of clinical and research laboratories and examine the national and international standards which inform these.
- Evaluate the accreditation and certification processes for a diagnostic laboratory in Australasia.
- Using appropriate digital platforms, access and assess the widely used quality assurance programs as applied to laboratory regulatory guidelines to Australasian laboratories.
- Critically review the NATA accreditation guidelines to plan and execute the design of a novel standard operating procedures.
Content
- Local and national regulatory requirements for storage and disposal of genetic test samples/data.
- Quality control and quality assurance.
- Certification and accreditation.
- The processes required for analytical or technical validation of a genetic test and production of a standard operating procedure (SOP). Clinical validity will be discussed.
- The types of quality assurance programs (QAP) utilised by genetic testing laboratories and the benefits of participating in such programs. Examples of the main QAP programs available in your region and those that your laboratory participates in.
- National and international standards for laboratory testing and how these standards differ from and interact with one another.
- The processes for laboratory accreditation in Australia and explain the interaction between NATA and local regulation.
- The main elements of International Standard ISO 15189 as they apply to a genetic testing laboratory.
- The roles and functions of the relevant regional authorities (e.g. NPAAC, NATA, IANZ, TGA), the processes they use, and the standards they employ to ensure compliance of a genetic testing laboratory.
- How currency of technical skills and competence is maintained and audited through staff meetings, training records, continuing education & professional development records.
- The main OH&S considerations for a diagnostic laboratory as they relate to chemicals/biological sample transport, handling, storage & disposal; hazard management; protective equipment; equipment maintenance; and emergency management.
- Level 1 versus Level 2 genetic testing and the informed consent documentation legally required by a testing laboratory for each.
- The role of the following stakeholders (or relevant regional equivalents) in defining legal, technical, clinical and ethical guidelines for genetic testing (National Health & Medical Research Council, NHMRC; the Royal College of Pathologists of Australasia, RCPA; Human Genetics Society of Australasia, HGSA).
- The research ethics framework in your region and contrast the process required for research consent for diagnostic testing.
Learning Approaches
This unit is designed to introduce you to the core concepts of lab management, compliance and quality control. The online delivery is through Canvas. The unit is developed around the principles of adult learning, theory and practice and open learning guidelines. As such, you will engage in self-directed learning as well as collaborative learning with your peers.
This predominantly, asynchronous learning environment allows you to go through lectures, materials and exercises at your own pace.
The Canvas site will provide you with timely learning resources including pre-recorded lectures, research papers, media articles and videos. Please ensure you take advantage of attending online meetings, completing interactive exercises, and interacting in online message boards. There will be at least one webinar or video-conferencing in which a concept is explained and students will be expected to solve a problem or discuss approaches to a case during the virtual class. These learning activities form part of your career development and aspects of employability.
The support for learning is embedded on Canvas will facilitate your ongoing conversations with other students and with academic staff. Guidance will be provided, through regular announcements in the Canvas site for you in terms of appropriate self-pacing of your study during the semester. You will be expected to engage in online discussions and complete formative assessment tasks to consolidate your learning.
You will be encouraged to read widely and to think critically about the nature and scope of how lab management, compliance and quality control relates to the field of diagnostic genomics.
Feedback on Learning and Assessment
The online webinars and discussion boards are the key places you can ask for and receive feedback on your understanding of course materials. Feedback on assessment 1 and assessment 2 will be given regarding your analytical skills, ability to identify resources, reasoning and ability to interpret and summarize your findings. Each assessment item will include individual feedback on your progress as stated above and feedback will be offered to the group through the Announcements page on the Canvas site.
Assessment
Overview
There are three formal assessment items in LQN201. Assessment 1 is a project which gives you the opportunity to synthesise the knowledge gained during this course to generate a standard operating procedure for a given laboratory technique. Assessment 2 is a written report which provides you the opportunity to analyse standard resources and study the literature in order for you to introduce a new quality assurance program. Assessment 3 is a viva voce which gives you the opportunity to review a standard operating procedure.
Unit Grading Scheme
7- point scale
Assessment Tasks
Assessment: Project
In this authentic assessment task you will take on the role of a laboratory scientist tasked with writing a standard operating procedure (SOP) for a laboratory test as part of NATA accreditation. You will be required to review NATA accreditation guidelines and present a SOP for a specific laboratory technique to your laboratory manager.
This assignment is eligible for the 48-hour late submission period and assignment extensions.
Assessment: Report
In this authentic assessment piece, you will be asked to introduce a new quality assurance program. You will write a document in which you report your proposed program, citing the policies and regulations on which it was based. The report will be geared towards the Director of Pathology of a hypothetical hospital who will need to assess the merit of the proposal along with the practical and fiscal implications of the proposed new system.
This assignment is eligible for the 48-hour late submission period and assignment extensions.
Assessment: Procedure review
In this authentic assessment piece, you are a senior scientist who is reviewing a Standard Operating Procedure (SOP) that has been produced by a laboratory technician. This viva voce is aimed to ensure that all students have a coherent knowledge of laboratory management, compliance and quality control which is required on a daily basis in a laboratory setting.
You will be given a Standard Operating Procedure (SOP) and will be asked to identify and correct errors such as unclear instructions, missing steps, and safety oversights. You will be given an hour to review the document and upload your answers in a video recording on the Canvas site. Clear instructions will be given on how to upload the video including a practice session during the semester. As part of Verified Identify Assessment, you will be required to show your student card in the video recording.
This assessment is eligible for the 48-hour late submission period and assignment extensions.
Academic Integrity
Academic integrity is a commitment to undertaking academic work and assessment in a manner that is ethical, fair, honest, respectful and accountable.
The Academic Integrity Policy sets out the range of conduct that can be a failure to maintain the standards of academic integrity. This includes, cheating in exams, plagiarism, self-plagiarism, collusion and contract cheating. It also includes providing fraudulent or altered documentation in support of an academic concession application, for example an assignment extension or a deferred exam.
You are encouraged to make use of QUT’s learning support services, resources and tools to assure the academic integrity of your assessment. This includes the use of text matching software that may be available to assist with self-assessing your academic integrity as part of the assessment submission process.
Breaching QUT’s Academic Integrity Policy or engaging in conduct that may defeat or compromise the purpose of assessment can lead to a finding of student misconduct (Code of Conduct – Student) and result in the imposition of penalties under the Management of Student Misconduct Policy, ranging from a grade reduction to exclusion from QUT.
Resources
In addition to online lecture notes, a selection of online textbooks, journal articles, and internet resources will be made available each week through QUT library.
Risk Assessment Statement
There are no out of the ordinary risks associated with this unit.
Course Learning Outcomes
This unit is designed to support your development of the following course/study area learning outcomes.LS72 Graduate Diploma in Diagnostic Genomics
- Apply scientific knowledge and skills, focused on current genomic trends in practice and research, utilising digital capabilities.
Relates to: ULO1, ULO4 - Critically evaluate scientific findings and locate solutions to solve complex genomics problems, employing high order cognitive skills, clinical reasoning, and reflective practice.
Relates to: ULO2, ULO3, ULO4 - Develop and apply professional oral and written communication skills that inform effective collaboration and digital interactions with colleagues and other stakeholders across the medical and scientific contexts.
Relates to: ULO3, ULO4 - Practise within a framework of personal accountability, collegiality and ethical judgment, while valuing cultural safety and sensitivity in professional practice, clinical decision-making and research.
Relates to: ULO3
LS81 Master of Diagnostic Genomics
- Apply scientific knowledge and skills, focused on current genomic trends in practice and research, utilising digital capabilities.
Relates to: ULO1, ULO4, Procedure review - Critically evaluate scientific findings and locate solutions to solve complex genomics problems, employing high order cognitive skills, clinical reasoning, and reflective practice.
Relates to: ULO2, ULO3, ULO4, Project, Report - Develop and apply professional oral and written communication skills that inform effective collaboration and digital interactions with colleagues and other stakeholders across the medical and scientific contexts.
Relates to: ULO3, ULO4, Project, Report - Practise within a framework of personal accountability, collegiality and ethical judgement, drawing upon Indigenous perspectives, cultural safety and sensitivity in professional practice, clinical decision-making and research.
Relates to: ULO3 - Plan and execute a substantial academic activity in the field of diagnostic genomics to address a specific research question.
Relates to: Report