This course is aimed at providing pathologists and scientists in Australia a good understanding of the following:

• Australian legislation and guidelines for pathology testing and their quality requirements, including the accreditation process and the requirements of ISO 15189 Medical laboratories – Requirements for quality & competence, the National Pathology Accreditation Advisory Council (NPAAC) guidelines, and the NATA accreditation guidelines and process including the use of the NATA Field Application Document (FAD). This will help pathologists and scientists who might not be involved in the day-to-day quality management system and regulatory activities of the laboratory to have a better grasp of the legislation, regulatory requirements, and quality management system. This will in turn assist the laboratories with their efficiency and process improvement activities.

• The systems and processes involved with the selection and introduction of IVDs into the laboratory, including the evaluation, validation and verification of IVDs, and the standardisation of tests. This knowledge will facilitate informed decision making as they select and introduce new diagnostic tests for existing and emerging health challenges.

• The principles of serology testing for blood screening, diagnosis, monitoring and surveillance, and the importance of clinical and diagnostic sensitivity, specificity and disease prevalence in developing testing strategies. This module will help develop testing strategies that benefit the patient both diagnostically (the patient will know what is wrong with them) and clinically (the clinicians can use the results to treat and manage the patient).

• The use of various NAT methods to diagnose, monitor and identify new viruses. The knowledge and skills gained are critical for Australia’s health security at a time where the spread of endemic and new viruses has led to global health emergencies and pandemics.

• How to assure and monitor the quality of test results through EQAS and QC, and the use of these data to identify and troubleshoot testing errors, illustrated by examples and case studies. This information will help ensure that high quality and accurate patient results are released at all times and improve their skills on how to troubleshoot testing errors using QC and EQAS data.

A series of five, two-hour interactive training sessions focusing on the quality requirements of, and quality assurance for, pathology laboratories that perform infectious diseases testing in Australia.

The topics covered for each session are:

• Session 1 (11 May 2023): Overview on quality requirements in pathology and laboratory accreditation (REGISTRATIONS ARE NOW CLOSED)
• Session 2 (25 May 2023): Introduction to in vitro diagnostics (IVDs)
• Session 3 (08 June 2023): Serology testing principles and an Overview of Nucleic Acid Testing (NAT) methods
• Session 4 (22 June 2023): Methods for monitoring test results: External Quality Assessment Schemes (EQAS)
• Session 5 (06 July 2023): Methods for monitoring test results: Quality Control (QC)

Please note that for these sessions, registrations close one week prior to the workshops

This course is applicable to all disciplines. Trainees can opt to attend only the sessions that are of specific interest to them, or all sessions.

AUD $80 excluding GST for each session, or $350 excluding GST for all 5 sessions.

The fee(s) will include PDF copies of presentation delivered during the session(s).

By completing this training, participants are eligible for APACE 2 CEU points on each training session. If participants register and complete all five training sessions, they will receive a certificate, as well as APACE 10 CEU points for the whole five events.

This course has been assessed by the RCPA Microbiology assessment committee, who have strongly recommended it to Pathology trainees.