Implementing structured pathology reporting protocol for non-melanocytic skin cancers: practical considerations.

Non-melanocytic skin cancers (NMSCs) account for five times the incidence of all other cancers combined and cost US $6 billion annually. These are the most frequent specimens encountered in community pathology practice in many Western countries. Lack of standardised structured pathology reporting protocols (SPRPs) can result in omission of critical information or miscommunication leading to suboptimal patient management.

Blood culture quality assurance: findings from a RCPAQAP Key Incident Monitoring and Management Systems (KIMMS) audit of blood culture performance.

Blood cultures (BC) are the gold standard investigation for bloodstream infection. Standards exist for BC quality assurance, but key quality indicators are seldom measured. The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) Key Incident Monitoring and Management Systems (KIMMS) invited laboratories for the first time to participate in an audit to determine adult BC positivity rates, contamination rates, sample fill volumes and the proportion received as a single set.

Investigating genomic medicine practice and perceptions amongst Australian non-genetics physicians to inform education and implementation.

Genomic medicine is being implemented on a global scale, requiring a genomic-competent health workforce. To inform education as part of implementation strategies to optimize adoption of genomics by non-genetics physicians, we investigated current practices, perceptions and preferences relating to genomic testing and education. Australian non-genetics physicians completed an online survey; we conducted univariate and multivariate analyses of determinants of confidence and engagement with genomic medicine.

Classification of "Near-patient" and "Point-of-Care" SARS-CoV-2 Nucleic Acid Amplification Test Systems and a first approach to evaluate their analytical independence of operator activities.

Background: European legislation defines as "near-patient testing" (NPT) what is popularly and in other legislations specified as "point-of-care testing" (POCT). Systems intended for NPT/POCT use must be characterized by independence from operator activities during the analytic procedure. However, tools for evaluating this are lacking.

Machine Learning in Laboratory Medicine: Recommendations of the IFCC Working Group.

Background: Machine learning (ML) has been applied to an increasing number of predictive problems in laboratory medicine, and published work to date suggests that it has tremendous potential for clinical applications. However, a number of groups have noted the potential pitfalls associated with this work, particularly if certain details of the development and validation pipelines are not carefully controlled.

Methods: To address these pitfalls and other specific challenges when applying machine learning in a laboratory medicine setting, a working group of the International Federation for Clinical Chemistry and Laboratory Medicine was convened to provide a guidance document for this domain.

Implementation of circulating tumour DNA multi-target mutation testing in plasma: a perspective from an external quality assessment providers' survey.

Demand for large-scale tumour profiling across cancer types has increased in recent years, driven by the emergence of targeted drug therapies. Analysing alternations in plasma circulating tumour DNA (ctDNA) for cancer detection can improve survival; ctDNA testing is recommended when tumour tissue is unavailable. An online survey of molecular pathology testing was circulated by six external quality assessment members of IQN Path to registered laboratories and all IQN Path collaborative corporate members.

Between and within calibration variation: implications for internal quality control rules.

The variability between calibrations can be larger than the within calibration variation for some measurement procedures, that is a large CV:CV ratio. In this study, we examined the false rejection rate and probability of bias detection of quality control (QC) rules at varying calibration CV:CV ratios. Historical QC data for six representative routine clinical chemistry serum measurement procedures (calcium, creatinine, aspartate aminotransferase, thyrotrophin, prostate specific antigen and gentamicin) were extracted to derive the CV:CV ratios using analysis of variance.

Dataset for the reporting of neoplasms of the heart, pericardium, and great vessels: recommendations from the International Collaboration on Cancer Reporting (ICCR).

The International Collaboration on Cancer Reporting (ICCR) was founded by major pathology organizations from around the world to produce internationally standardized and evidence-based datasets for pathologists' reporting of cancer. Its goal is to improve cancer patient outcomes worldwide and to advance international benchmarking in cancer management. The ICCR cancer dataset development schedule is aligned with revisions of the WHO Classification of Tumours ("Blue Book") series, and in 2015 ICCR developed an initial series of thoracic datasets including a dataset for neoplasms of the heart, pericardium, and great vessels.

The effect of the immunoassay curve fitting routine on bias in troponin.

Objectives: Unlike many dose-response curves used in clinical chemistry, the immunoassay curve used to quantitate measurands is often sigmoidal rather than linear. Consequently, a more complex curve fitting model is required. Various models are available, but they can introduce bias, and there can be little awareness of why this error can be introduced.

The next wave of innovation in laboratory automation: systems for auto-verification, quality control and specimen quality assurance.

Laboratory automation in clinical laboratories has made enormous differences in patient outcomes, with a wide range of tests now available that are accurate and have a rapid turnaround. Total laboratory automation (TLA) has mechanised tube handling, sample preparation and storage in general chemistry, immunoassay, haematology, and microbiology and removed most of the tedious tasks involved in those processes. However, there are still many tasks that must be performed by humans who monitor the automation lines.

Establishment of RCPA national guidelines for selective reporting of antimicrobials: processes, challenges and measuring the impact.

Objectives: In 2016, The Royal College of Pathologists of Australasia (RCPA) initiated the formation of a working group comprising medical microbiologists to establish guidelines to assist Australian laboratories to implement selective and cascade reporting of antimicrobials-the first guidelines of this type in the world.

Methods: A 2017 audit of antimicrobial reporting in Australian and New Zealand laboratories identified significant opportunities for improvement and standardization of selective reporting.

Results: The first draft of the RCPA Selective Reporting Guidelines was circulated to all RCPA Microbiology fellows for feedback in August 2018 and the first version was published in February 2019.

Validation of a commercial line blot for the detection of serum anti-Ro60 autoantibodies.

Serum anti-Ro60 is one the most frequently encountered autoantibodies in the diagnostic immunopathology laboratory and in clinical practice. A large variety of assays are available to detect this including the popular multiplex line immunoblot (IB) assay. We evaluated the analytical performance of the IB for anti-Ro60 detection, using the counterimmunoelectrophoresis (CIEP) method as the 'gold standard'.

Improving Youden plots by including analytical performance specifications.

Historically, Youden plots are made of a scatter plot of the results of two EQA samples with an elliptical confidence area around them. Because Youden plots compare individual laboratory results with respect to other laboratories, they intrinsically evaluate with state of the art. In the field of medical laboratory science, analytical performance specifications have been proposed and various EQA providers show these limits on Youden plots by horizontal and vertical lines near the limits of total error.

Rapid On-Site Evaluation Technical Exercise Using Digital Pathology: Peer Comparison in an External Quality Assurance Setting.

Background: The Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) is a world leader in the provision of external quality assurance (EQA) for pathology laboratories. The development and delivery of new programmes are designed to meet the evolving needs of our participants and pathology practice. A cytopathology technical programme was established in 2018 to provide proficiency testing in routine cytopreparatory techniques.

Attitudes of Australasian Clinicians and Laboratory Staff to Changing Fungal Nomenclature: Has Mycological Correctness Really Gone Mad?

Fungal nomenclature changes have been a regular occurrence in recent years, eliciting heated debate on whether such changes will confuse clinicians and harm patients. We conducted surveys of Australasian laboratory staff and clinicians to assess attitudes, practices, and concerns regarding nomenclatural change. The majority of respondents to both surveys were aware of fungal nomenclatural changes (93.

The preservation of synovial fluid using dimethyl sulfoxide.

Background: The Royal College of Pathologists of Australasia Quality Assurance Programs runs a Quality Assurance Program for the assessment of synovial fluid crystals. It provides aliquots of synovial fluid to various laboratories. The quality of specimens can deteriorate prior to being examined.

External quality assessment providers' services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions.

Objectives: Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the respective scopes of regulatory and economic framework conditions, differing levels of quality efforts to safeguard laboratory performance can be anticipated.

A framework for evaluating the frequency of external quality assessment challenges.

Background And Aims: No clear rules about the optimal frequency of organizing External Quality Assessment (EQA) rounds exist. More frequent challenges will facilitate faster responses and more reliable statistics. Adding extra samples leads to extra information, but the correlation between results from different samples reduces the extra information from additional samples.