Recent Activities - 2021
Training on Quality Requirements for Pathology Laboratories Performing Infectious Diseases Testing
On Friday 30 July 2021, NRL conducted a one-day training on the quality requirements for Australian pathology laboratories performing infectious diseases testing, for nine Royal College of Pathologists, Australasia microbiology registrars based at hospitals across Victoria. The purpose of the training was to introduce and review pertinent topics relating quality requirements for medical microbiology laboratory testing that would inform clinical decision-making and diagnoses, and support good patient outcomes.
The training started with an overview on the Australian quality requirements in pathology, covering relevant Medicare legislation, ISO 15189 standard, National Pathology Accreditation Advisory Council (NPAAC) guidelines, National Association of Testing Authorities (NATA) Field Application Documents and national testing policies. Mechanisms for the surveillance and monitoring against the standards was reviewed.
This was followed by an introduction to in-vitro diagnostics (IVDs), the Australia and international regulatory system that supports IVDs, the selection and evaluation and validation of test kits, testing algorithms, standardisation of infectious disease tests, and the difference between clinical chemistry and serology.
The monitoring of test performance using External Quality Assessment Schemes (EQAS) was then discussed in the context of what can go wrong in laboratory testing, EQAS aims and requirements for laboratories, how laboratories can choose a quality EQAS provider, and the use of EQAS data to identify and troubleshoot testing errors. The topic also included an interactive session using real data sets.
Monitoring test results using Quality Control (QC) was next discussed. The use of QC in industry and traditional testing laboratories was reviewed, along with the statistics used in the assessment of data. The use of QC in the Infectious Diseases testing was discussed and included alternative approaches to setting acceptance criteria through the use of QConnect Limits. An explanation to why statistics need to differ for serology was also discussed. Several examples and case studies were reviewed.
NRL would like to thank Marcel Leroi, Director of Microbiology at Austin Health, and the Royal College of Pathologists of Australasia (RCPA), for their support with this training.