The Australian Society for Microbiology (ASM) and the National Serology Reference Laboratory (NRL) have developed guidelines on the use of quality controls to support the interpretation of serology and nucleic acid tests used in infectious disease.
The information below, produced by the ASM – is of relevance to NATA Members accredited to ISO 15189.
The use of a quality control sample is a requirement for laboratories accredited to ISO 15189 and NPAAC Requirements. However, the standards are written as general principles and are not specific on how the requirements can be achieved.
NATA’s ISO 15189 Standard Application Document (SAD) includes specific information for Human Pathology laboratory disciplines, including Cartridge-based instruments Chemical pathology, Cytopathology, Haematology, Histopathology, Microbiology and immunopathology.
A notable exception is infectious disease testing which includes serology and nucleic acid testing. Laboratory scientists and managers know that a ‘one-size-fits-all’ approach to QC principles does not work for all laboratory disciplines.
Yet some laboratories use out of date processes, lack appropriate controls or use processes that are not scientifically robust. Laboratories often interpret the standard to suggest that the use of a kit control is adequate to fulfil the requirement, a practice that is common in clinical chemistry but not always appropriate for other disciplines.
Because of this, the ASM, in collaboration with the NRL, have developed a set of guidelines to address this shortfall. A full review of the new requirements can be found in https://doi.org/10.1071/MA24013.
In summary, the Guidelines state:
- Controls provided by the manufacturer (kit controls) must be used if the manufacturer’s instructions for use (IFU) state that their use is required.
- If the use of kit controls is not required by the manufacturer’s IFU, then a laboratory must use at least one of a kit control or a third-party external quality control (EQC) to validate the test each day the test is used.
- Use of both kit controls and EQC is recommended. Where suitable EQC specimens are available, their use in maintaining QC is recommended.
- If the laboratory uses the kit controls to validate the test, they must use the validation rules specified by the manufacturer.
- If the laboratory uses EQCs to validate the test, the EQC must be validated by the laboratory for use on that test.
- The laboratory must have a documented method for establishing acceptance criteria for an EQC based on scientific evidence that is validated using infectious disease data.
- The laboratory must have documented procedures for interpreting results when the controls are outside the established acceptance criteria.
The additions will provide more certainty to Human Pathology laboratories when implementing and reviewing quality control processes for infectious disease testing and aligns with other standards and regulatory requirements including those from TGA.
If you have any queries, please contact:
Professor Mark Schembri
President, Australian Society for Microbiology; Fellow, ASM & AAM
Belinda McEwan
ASM representative on the National Association of Testing Authorities (NATA) – Human Pathology Accreditation Advisory Committee