The challenge of producing an EQA for the COVID-19 pandemic.

The COVID-19 pandemic has changed the clinical medicine landscape. The importance of pathology testing has come to the forefront. Patients or potential patients are dealing directly with laboratories as they line up in carparks or testing staff come to the front doors to obtain samples.

Laboratory biosafety measures involving SARS-CoV-2 and the classification as a Risk Group 3 biological agent.

The current public health emergency surrounding the COVID-19 pandemic, that is the illness caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in thousands of cases in Australia since 25 January 2020 when the first case was diagnosed. This emerging virus presents particular hazards to researchers and laboratory staff in a clinical setting, highlighted by rapid and widespread global transmission. Based on the epidemiological and clinical data that have become available in mid-2020, we propose the interim classification of SARS-CoV-2 as a Risk Group 3 organism is reasonable, and discuss establishing Biosafety Level 3 (BSL-3) regulations accordingly.

Results From 16 Years of Quality Surveillance of Urine Albumin to Creatinine Ratio Testing for a National Indigenous Point-of-Care Testing Program.

Context.—: The burden of chronic kidney disease in Indigenous Australians is 7.3 times higher than that of non-Indigenous Australians.

Influence of isotopically labeled internal standards on quantification of serum/plasma 17α-hydroxyprogesterone (17OHP) by liquid chromatography mass spectrometry.

Objectives Our recent survey of 44 mass spectrometry laboratories across 17 countries identified variation in internal standard (IS) choice for the measurement of serum/plasma 17α-hydroxyprogesterone (17OHP) by liquid chromatography-tandem mass spectrometry (LC-MS/MS). The choice of IS may contribute to inter-method variations. This study evaluated the effect of two common isotopically labeled IS on the quantification of 17OHP by LC-MS/MS.

Performance measures for Australian laboratories reporting cervical cytology 2009-2017: the impact of the national HPV vaccination program.

The significant decrease in the incidence of cervical cancer in Australian women since the implementation of an organised approach to cervical screening through the National Cervical Screening Program (NSCP) can be largely attributed to high-quality cervical cytology reporting by Australian laboratories. Performance measures for Australian laboratories reporting cervical cytology are a well-established and an integral part of monitoring and maintaining this high standard by facilitating interlaboratory comparison of performance. This study summarises the aggregate data collected annually by Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) over the decade from 2009 until 30 November 2017, when the NCSP was revised and the cervical screening test replaced the Pap test as the primary mode of screening women for preinvasive disease.

Harmonising EQA schemes the next frontier: challenging the status quo.

There is a focus on standardisation and harmonisation of laboratory results to reduce the risk of misinterpretation of patient results assayed in different laboratories. External quality assessment (EQA) is critical to assess the need for harmonisation and to monitor the success of procedures to achieve harmonisation. However, EQA providers are being stretched to meet the needs of their participants with proven commutable material with reference method targets, a range of clinically significant levels of the materials, detailed and customised data analysis, and educational support.

Changes in error rates in the Australian key incident monitoring and management system program.

Introduction: The Key incident monitoring and management system program (KIMMS) program collects data for 19 quality indicators (QIs) from Australian medical laboratories. This paper aims to review the data submitted to see whether the number of errors with a higher risk priority number (RPN) have been reduced in preference to those with a lower RPN, and to calculate the cost of these errors.

Materials And Methods: Data for QIs from 60 laboratories collected through the KIMMS program from 2015 until 2018 were retrospectively reviewed.

Anticoagulant Initiation During Hospital Admissions for Atrial Fibrillation in South-East Queensland, Australia.

Background: Anticoagulation reduces stroke risk in patients with atrial fibrillation (AF) but under-prescribing in eligible patients has been commonly reported. Introduction of the direct acting oral anticoagulants (DOACs) was considered to potentially improve prescribing due to increased anticoagulant options. At the time of release to the Australian market, there were limited studies investigating anticoagulant usage during hospitalisations for AF.

From Somatic Variants Toward Precision Oncology: An Investigation of Reporting Practice for Next-Generation Sequencing-Based Circulating Tumor DNA Analysis.

Background: With the accelerated development of next-generation sequencing (NGS), identified variants, and targeted therapies, clinicians who confront the complicated and multifarious genetic information may not effectively incorporate NGS-based circulating tumor DNA (ctDNA) analysis into routine patient care. Consequently, standardized ctDNA testing reports are of vital importance. In an effort to guarantee high-quality reporting performance, we conducted an investigation of the current detection and reporting practices for NGS-based ctDNA analysis.

Laboratory testing for activated protein C resistance: rivaroxaban induced interference and a comparative evaluation of andexanet alfa and DOAC Stop to neutralise interference.

Background Investigation of hemostasis is problematic when patients are on anticoagulant therapy. Rivaroxaban especially causes substantial interference, extending many clot-based tests, thereby leading to false positive or negative events. In particular, rivaroxaban affects some assays for activated protein C resistance (APCR).

Highlighted issues from the second edition RCPA Endometrial Cancer Structured Reporting Protocol.

Endometrial cancer is the most common malignancy of the female genital tract in the Western world. The second edition Endometrial Cancer Structured Reporting Protocol was published to the Royal College of Pathologists of Australasia (RCPA) website in December 2019, and relates to the reporting of endometrial cancer in hysterectomy specimens. This editorial discusses selected key issues from the second edition of the RCPA protocol, and addresses future challenges in pathology reporting of endometrial cancer.

The SAMe-TTR score as an indicator of warfarin control for patients with deep vein thrombosis in Queensland, Australia.

Oral anticoagulation options for patients with venous thromboembolism (VTE) include vitamin K antagonists like warfarin. Good warfarin control is linked to outcomes of therapy, and the SAMe-TTR model has been reported to predict control in atrial fibrillation patients with scores ≥ 2 linked to poor control. There has been limited and conflicting data in VTE populations, therefore this study aimed at determining the predictive ability of this model in Australian patients with deep vein thrombosis.

Reducing the effect of DOAC interference in laboratory testing for factor VIII and factor IX: A comparative study using DOAC Stop and andexanet alfa to neutralize rivaroxaban effects.

Introduction: Investigation of factors (F) VIII and IX is common, with testing important for diagnosis or exclusion of haemophilia A or B, associated acquired conditions and factor inhibitors. Rivaroxaban, a common direct anti-Xa agent, causes significant interference in clotting assays, including substantial false reduction of factor levels.

Aim: To assess whether rivaroxaban-induced interference of FVIII and FIX testing could be neutralized.

Detecting reagent lot shifts using proficiency testing data.

Clinically significant systematic analytical shifts can evade detection despite between-lot reagent verification, quality control and proficiency testing systems practiced by most laboratories. Through numerical simulations, we present two methods to determine whether there has been a shift in the proficiency testing peer group of interest, peer group i, using the measurements from peer group i and J other peer groups. In method 1 ('group mean'), the distance of peer group i from the mean of the other J peer groups is used to determine whether a shift occurs.

An external quality assurance trial to assess mass spectrometry protein testing facilities for identifying multiple human peptides.

The application of proteomic liquid chromatography mass spectrometry (LC-MS) for identifying proteins and peptides associated with human disease is rapidly growing in clinical diagnostics. However, the ability to accurately and consistently detect disease-associated peptides remains clinically uncertain. Variability in diagnostic testing occurs in part due to the absence of appropriate reference testing materials and standardised clinical guidelines for proteomic testing.

Dataset for the reporting of renal biopsy for tumour: recommendations from the International Collaboration on Cancer Reporting (ICCR).

The International Collaboration on Cancer Reporting (ICCR) has developed a suite of detailed datasets for international implementation. These datasets are based on the reporting protocols developed by the Royal College of Pathologists (UK), The Royal College of Pathologists of Australasia and the College of American Pathologists, with modifications undertaken by international expert groups appointed according to ICCR protocols. The dataset for the reporting of renal biopsy for tumour is designed to provide a structured reporting template containing minimum data recording key elements suitable for international use.