LQN201 Lab Management, Compliance and Quality Control


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Unit Outline: Semester 1 2024, Online

Unit code:LQN201
Credit points:12
Coordinator:Robert Smith | r157.smith@qut.edu.au
Disclaimer - Offer of some units is subject to viability, and information in these Unit Outlines is subject to change prior to commencement of the teaching period.

Overview

Genomic scientists, whether based in a clinical or research laboratory, need to understand all aspects of laboratory management from compliance, accreditation and regulation through to safety and quality control.

Learning Outcomes

On successful completion of this unit you will be able to:

  1. Describe the regulation of clinical and research laboratories and the national and international standards which inform these.
  2. Evaluate the accreditation and certification processes for a diagnostic laboratory in Australasia.
  3. Apply widely used quality assurance programs and laboratory regulatory guidelines to Australasian laboratories.
  4. Generate novel standard operating procedure.

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. 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 resources including pre-recorded lectures, research papers, media articles and videos. You will also be able to access online meetings, interactive exercises and 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.

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 case study 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 presentation 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 written exam which will consist of a mixture of multiple choice, short answer and extended answer questions. This exam will take place over a one-hour period and will be administered online via Canvas.

Unit Grading Scheme

7- point scale

Assessment Tasks

Assessment: Project

This authentic assessment will present you with the title of a laboratory test and ask you to write a standard operating procedure (SOP) as required for NATA accreditation of a laboratory. You will be required to review NATA accreditation guidelines and present a SOP for a specific laboratory technique.

This is an assignment for the purposes of an extension.

Relates to learning outcomes
4.

Weight: 35
Individual/Group: Individual
Due (indicative): Mid-semester
Related Unit learning outcomes: 4

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 present your proposed program, citing the policies and regulations on which it was based. The presentation 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 is an assignment for the purposes of an extension.

Relates to learning outcomes
3.

Weight: 35
Individual/Group: Individual
Due (indicative): End-semester
Related Unit learning outcomes: 3

Assessment: Examination

This written examination 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.

 

Relates to learning outcomes
1 and 2.

Weight: 30
Individual/Group: Individual
Due (indicative): Central exam period
Related Unit learning outcomes: 1, 2

Academic Integrity

Students are expected to engage in learning and assessment at QUT with honesty, transparency and fairness. Maintaining academic integrity means upholding these principles and demonstrating valuable professional capabilities based on ethical foundations.

Failure to maintain academic integrity can take many forms. It includes cheating in examinations, plagiarism, self-plagiarism, collusion, and submitting an assessment item completed by another person (e.g. contract cheating). It can also include providing your assessment to another entity, such as to a person or website.

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.

Further details of QUT’s approach to academic integrity are outlined in the Academic integrity policy and the Student Code of Conduct. Breaching QUT’s Academic integrity policy is regarded as student misconduct and can lead to the imposition of penalties 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.