Royal College Of Pathologists Of Australasia Research Articles

Beyond the basics: Sigma scores in laboratory medicine with variable total allowable errors (TEa)

BackgroundTo diagnose diseases, track the effectiveness of treatments and make well-informed clinical decisions, doctors rely on results from laboratories. Accurate and precise results minimize the necessity for additional testing, saving time and money while enhancing patient satisfaction.. Internal quality control and an external quality assurance scheme(EQAS) are metrics used to evaluate a clinical laboratory’s performance. One of the numerous quality indicators that can be used to gauge the amount of errors is sigma metrics. To calculate the sigma scores bias%, CV%, and Total Error Allowable (TEa) are needed. Total Error allowable(TEa) is a crucial benchmark that establishes allowed limits on the degree of deviation from the target value for a certain analyte. Nevertheless, a proper consensus for establishing a TEa goal has not been reached and the impact of this limiting factor in standard laboratory practice and sigma calculation has not been sufficiently established. Choosing the right Total Error allowable(TEa) goal is one of the greatest challenges when employing sigma metrics as depending on the source, several measurands of TEa values may exhibit alteration. Material and methodsOur study aims to determine the sigma scores of 20 routine chemistry parameters using six different TEa sources: Clinical Laboratory Improvement Amendment (CLIA 88′), CLIA(Clinical Laboratory Improvement Amendment) 24, BDV (Biological Variation Desirable), RCPA(Royal College of Pathologists of Australasia), RiliBak(Guideline of the German Medical Association for Quality Assurance of Laboratory Medical Examinations), and EMC/Spain(Measurement and Control Scheme) over a 12-month period using the bias percent from the External Quality Assessment Scheme (EQAS) and coefficient of variation (CV) from the Internal Quality Control (IQC). Detection system was automated, multi-channel, selective analyzer, the Beckman Coulter AU680 which works on the principle of spectrophotometry. To compute the Sigma metrics, formula used was Sigma = (TEa – Bias%) / CV%. By comparing the sigma values from the different TEa sources, TEa variance on the evaluation of the sigma metric was ascertained after which an internal quality control plan and QGI(Quality Goal Index) for underperforming parameters were devised. ResultsThe study discovered that the sigma values of common chemical parameters varied significantly based on the TEa sources used. Maximum parameters in the above three-sigma zone were TBil, HDL, CK, ALP, amylase and uric acid in CLIA’88 while RCPA and Biological variation were determined to be the most severe, with the highest performing parameters falling below three sigma zones. Rilibaek was the most liberal, with only sodium in the lower three sigma zones along with CLIA’88. The findings indicate that there is the substantial influence of various Total Error Allowable (TEa) sources on the sigma metric evaluation. A quality control plan was devised depending on different sigma scores of the analytes using biorad unity 2.0 software(westgard sigma multirules). The origins of errors that resulted in low sigma ratings liked enhanced cleaning of electrodes, electrode replacement, ageing of reagents, instrument maintainence were pinpointed and addressed. ConclusionThe study highlights the necessity of harmonizing and standardizing sigma metrics, stressing the significance of choosing suitable total error allowable goals (TEa). The creation of worldwide standards and recommendations for total error allowable (TEa) can lead to its harmonization. Establishing a consensus on the acceptable levels of error for various laboratory tests would necessitate the cooperation of specialists from many nations and organizations in order to set such guidelines and standards.

Pathology requesting in a regional Australian Emergency Department; an observational study comparing current practice with college guidelines.

In 2018, the Australasian College for Emergency Medicine (ACEM) and the Royal College of Pathologists of Australasia (RCPA) produced a guideline to encourage appropriate pathology requesting in the Emergency Department (ED). To assess adherence to the ACEM/RCPA pathology testing guideline in a regional ED. This was a retrospective observational study conducted at a regional Australian ED over 7 days. Adults with a presenting complaint encompassed by the guideline were included. All blood tests were audited against the guideline recommendations and classified as indicated or non-indicated. Chi-squared analyses were performed to explore the association between presenting complaint and non-indicated testing. The primary outcome was the number of non-indicated blood tests. Forty percent of tests ordered were not clinically indicated, with non-indicated testing occurring during 87% of encounters. The C-reactive protein (CRP) was the test most frequently ordered outside of guidelines (94% non-indicated). Patients presenting with lower abdominal pain accounted for nearly one-quarter of all non-indicated tests. Blood tests were commonly requested outside of the guideline recommendations and interventions to improve pathology stewardship are required.

B-120 Atellica® Ci 1900 Assay Sigma Metrics Evaluation

Abstract Background The Atellica® CI 1900 Analyzer is a stand-alone, integrated clinical chemistry and immunoassay analyzer. Offering the same assay portfolio as the Atellica® Solution, the Atellica® CI 1900 analyzer is designed to complement the Atellica® Solution in hub-and-spoke settings, enabling labs of every size to offer state-of-the-art patient testing. Six Sigma is synonymous with process performance, and Sigma metrics have become the analytical quality benchmark for the medical device industry. In this study, Sigma metrics were calculated for a total of 71 Atellica® assays to provide a simple, translatable value to evaluate a given assay’s performance on the Atellica® CI 1900 Analyzer. Methods Allowable total error (ATE) for each assay was defined from the Clinical Laboratory Improvement Amendment (CLIA) table. When an analyte was not present in the CLIA table, alternative sources were consulted, including the RiliBÄK table, Royal College of Pathologists of Australasia (RCPA) table, and Ricos Biological Variability. Precision studies were conducted in accordance with Clinical and Laboratory Standards Institute (CLSI) document EP05-A3 over 20 days (n = 80 replicates) using the Atellica® CI 1900 Analyzer. Method comparison studies conducted on the Atellica® CI and Atellica® CH/IM Analyzers, with at least 100 patient samples spanning the assay’s measuring interval in accordance with CLSI document EP09-A3, were used to establish bias at the selected target precision concentration. Sigma metrics were determined for each assay using the equation Sigma metric = (ATE – %bias)/(Within-lab %coefficient of variation [CV]). Results Sigma metrics were determined for a total of 71 Atellica® assays, resulting in 93% of assays performing above Five or Six Sigma and 0 assays performing below 4 Sigma. Of these, 44 of 52 clinical chemistry and 15 of 19 immunoassays performed above the 6 Sigma level. Conclusions Sigma metrics that provide a benchmark for laboratory quality classify over 90% of assays on the Atellica® CI 1900 Analyzer with scores of 5 or 6, corresponding to the classification of excellent or world-class performance. Therefore, laboratories can expect high quality assay performance with strong comparability between the Atellica® CI 1900 Analyzer and the Atellica® Solution. **Not available for sale in the US. Product availability varies by country.

B-133 Beckman Coulter’s DxC 500 AU Clinical Chemistry Analyzer, Assessed by Six Sigma Metrics, Meets and Exceeds the Demands of CLIA 2024 Performance Specifications

Abstract Background The analytical Sigma-metric is a quality assessment tool, derived from the well-known Six Sigma management approach, and has been employed in Clinical Chemistry Assay performance assessments for over two decades. The analytical Sigma-metric, for an analyte or test in the clinical laboratory, is calculated using three variables that are routinely available; imprecision (CV), inaccuracy (bias) and total allowable error (TEa), all expressed as percentages or all in units. A range of assays were assessed for Sigma-metric performance including ISE chemistries for urine and serum, IgG serum and CSF, CRP serum and Glucose serum, urine and CSF, on the Beckman Coulter DxC 500 AU. The Beckman Coulter DxC 500 AU clinical chemistry analyzer* is the latest system from Beckman Coulter. It is a fully automated, random-access analyzer, designed for low to medium volume laboratories, with a throughput of 800 tests/h including ISEs. Methods To assess the 6-sigma performance of the assays on the DxC 500 AU, the standard analytical equation was used; Sigma metric = (TEa-|Bias|)/CV. Precision data was generated following the CLSI EP05 guideline, utilizing the 20-day protocol with test samples at various levels tested twice a day with a minimum of 2 h between runs. Relative bias was determined through a method comparison study tested, following the CLSI EP09-A3 guideline, between the DxC 500 AU and the DxC 700 AU, and evaluated a minimum of 100 samples completed over a minimum of 3 days. Bias was calculated at various levels across the dynamic range utilizing both Passing-Bablok and Deming regression models. The 6-sigma performance was assessed against total error (TE) goals from various sources including the new CLIA 2024 performance criteria for serum, Royal College of Pathologists of Austral-Asia (RCPA) ALP for urine assays, and in one case, the Wisconsin State Lab of Hygiene (WSLH) goal for a CSF analyte. Results Urine applications for ISEs and Glucose all demonstrated >6-sigma performance. The glucose CSF demonstrated >5-sigma performance while the IgG CSF assay demonstrated >3-sigma performance. For the serum applications, all assays demonstrated >4-sigma performance, with CRP, glucose and chloride demonstrating >6-Sigma, IgG >4-sigma and potassium and sodium >5-sigma. Through the use of Westgard Sigma Rules, this indicates that most assays do not require extensive multi-rule monitoring, but instead can rely on fewer rules with wider control limits. Conclusion Excellent performance has been demonstrated for the assays evaluated, with all urine applications performing at >6-sigma and serum assay at >4-sigma, and CSF assays performing at >3-sigma. Sigma-metric analysis confirms the instrument will meet or exceed adherence to the coming, tighter CLIA 2024 performance specifications. Further, QC for these assays can be optimized to reduce the number of rules, levels, and runs implemented for routine monitoring. The resulting optimized process enables the laboratory to produce quality results efficiently with increased confidence for proper test interpretation. *Product In development. Pending clearance by the United States Food and Drug Administration and achievement of CE compliance. Not currently available for in vitro diagnostic use.

Slice by slice: An Australian state-by-state analysis of Mohs micrographic surgery over 5 years.

In November 2018, Mohs micrographic surgery (MMS) was restricted to fellows registered with the Australasian College of Dermatologists. Three new item numbers for the provision of MMS were also introduced. We examine the national and state usage of MMS item numbers based on Medicare claim statistics and Mohs surgeons' self-reported data, noting the impact of the pandemic and the usage of individual item numbers. Medicare item number data were obtained from the Medicare Benefits Schedule website for January 2017-December 2021. Self-reported data were collected on an annual basis by the Royal College of Pathologists of Australasia (RCPA) as part of the Quality Assurance Program (QAP) from 2019 onwards. Data were analysed with the Holt-Winters smoothing method for forecasting. An increasing number of MMS claims were processed each year, with a total of 89,183 for the study period. Since November 2018, 97.7% of procedures have been conducted on the head, neck, genitalia, hand, digits, leg (below the knee) or foot. The provision of services across the country was maintained during the pandemic years of 2020-2021, with an increase in services in Queensland. There were discrepancies between the states for procedures performed in greater than six sections; these constituted more than 35% of claims in Queensland and Western Australia compared to less than 15% in other states. The pandemic impacted certain states more than others, with Victoria and the Northern Territory having significantly fewer presentations than predicted (p < 0.05). Overall, the use of MMS in Australia is in keeping with peer-developed guidelines, despite discrepancies between states. Although certain states were more severely affected by the pandemic, MMS is increasingly used in Australia.

Missing parameters in malignant polyp histology reports: can appropriate decisions be made?

The treatment of colorectal malignant polyps is dependent upon quality reporting of the histopathological features known to predict the risk of residual disease or lymph node metastasis. The Royal College of Pathologists of Australasia (RCPA) has produced protocols covering mandatory and recommended pathological parameters to be included in the pathology reporting of malignant polyps. This paper aimed to assess the quality of the pathological reporting in a population-wide analysis from 2011-2019 in Queensland, Australia. A retrospective population-wide cohort study was performed using the Queensland Oncology Repository as a data source. The number of missing pathological parameters (assessed against the RCPA protocol standards and guidelines) for each patient was then summed. Demographic and other patient details were collated. The number of patients whose recommended treatment could theoretically be altered by the full reporting of missing parameters was calculated. A total of 1,646 histopathological reports of malignant polyps were reviewed. From this, 30.8% of all reports had a sufficient number of missing parameters that may have seen an alternate management strategy chosen. The most commonly under-reported parameter from the standards was either a Haggitt or Kikuchi level with 48.6% missing. Synoptic reporting significantly reduced the mean number of missing pathological parameters (p<0.001) There was a significant improvement in the number of missing pathological details over time (p<0.001). Accurate and complete pathology reports are essential to formulate appropriate surgical recommendations after the resection of malignant polyps. In this population-based study, pathology reports remain incomplete for the established parameters despite the introduction of an RCPA structured reporting protocol. Fortunately, the quality of pathological reporting has improved since the introduction of the first RCPA protocol covering reporting of malignant polyps.

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

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. A 2017 audit of antimicrobial reporting in Australian and New Zealand laboratories identified significant opportunities for improvement and standardization of selective reporting. 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. Subsequently, version two of the guidelines has recently been published in Australia, and New Zealand adapted these guidelines for formulation of their own national guidelines to accommodate local needs. Here we describe the processes, acceptance and challenges associated with the establishment of these guidelines and measurement of their impact.

Evaluating Performance of Contemporary and Historical von Willebrand Factor (VWF) Assays in the Laboratory Identification of von Willebrand Disease (VWD): The Australasian Experience.

von Willebrand disease (VWD) is a common bleeding disorder that arises from deficiency and/or defects of von Willebrand factor (VWF). Appropriate diagnosis of VWD, including differential identification of qualitative (types 2A, 2B, 2M, 2N VWD) versus quantitative (types 1 and 3 VWD) defects remains problematic but has important management implications, given differential therapy. Complete assessment for VWD in a patient with a bleeding history requires comprehensive test panels, including VWF activity and antigen. We describe the Australasian experience, using data from the Royal College of Pathologists of Australasia (RCPA) Quality Assurance Program (QAP) related to VWF testing in their VWD test module. The RCPAQAP has been providing samples for VWF testing since 1998, representing 25 years of proficiency testing related to VWD diagnosis. A total of 109 samples have been dispatched to participants over these years, with current assessment involving dispatches of two samples (=4 samples) per year. Samples have represented all types of VWD, as well as normal or other samples, including acquired von Willebrand syndrome and plasma VWF concentrates as used in VWD therapy. Different VWF assays and activity/antigen ratios show different utility in VWD and type identification. In the past 9 years of data capture, a total of 166 errors were identified from a total of 1,839 interpretations, representing a base error rate of 9.0%. Identification errors were highest for type 2 VWD samples (15.3%), intermediate for type 1 VWD samples (7.5%), and lowest for normal samples (2.4%). Errors can be linked to assay limitations, including assay variability and low-level VWF detection limits, as well as laboratory issues (including test result misinterpretation, which accounts for approximately 40% of all errors for type 2 VWD). For test-associated errors, VWF:RCo and VWF:GPIbM were associated with the highest variability and error rate, which was up to 10x higher than that using VWF:CB. As a test group, chemiluminescence-based procedures were associated with lowest inter-laboratory variability, best low-level VWF detection (down to <1 U/dL), and least errors overall. These findings inform on reasons behind high rates of errors associated with VWD diagnosis, with some assays and methodologies performing substantially better than others.

Mainstreaming proteomics into rare disease diagnostics

Mitochondrial diseases are a group of highly heterogeneous disorders caused by mutations in over 350 known genes. Reported genomic diagnostic yields for mitochondrial disorders are in the range of 40–60%. A factor contributing to a lack of molecular diagnosis is the availability of functional tests to demonstrate variant pathogenicity in a timely and cost-effective manner. The gold-standard and National Association of Testing Authorities (NATA)/Royal College of Pathologists of Australasia (RCPA) accredited functional test measures the enzyme activities of mitochondrial respiratory chain complexes I–IV, however this test is not specific as defects in hundreds of genes can lead to an abnormal result.

Strengthening laboratory capacity for HIV vaccine clinical trials and epidemiological studies in Eastern and Southern Africa

Background: Conducting successful HIV vaccine clinical trials in resource-limited settings is hampered by lack of adequate laboratory capacity at trial sites, poor infrastructure, lack of well-trained technical personnel, and inadequate laboratory quality management Systems. We describe our approach to establishing sustainable laboratory capacity for clinical trials in Africa. Methods: IAVI identified 9 CRCs where a capacity building program that supports immunology and clinical testing was established. Information from the 9 CRCs was collected retrospectively and compiled in Microsoft excel for descriptive statistics. Mapping was done in Quantum Geographic information system. Results: Newly built and refurbished laboratories have been equipped with the required testing laboratory equipment. All CRC laboratories (n=10, 100%) received Good Clinical Laboratory Practice (GCLP) accreditation between 2004 and 2016, and accreditation maintained annually. A total of 89 audits were done between 2005-2019. KAVI and KEMRI had the highest number of audits (n=11, 12.4%). IAVI successfully trained a total of 1811 individual, of which (n=1130, 62.7%) trained on GCLP, (n=330, 18.3%) Quality Management Systems, (n=311, 17,2%) laboratory techniques and (n=32,1.8%) between 2004 and 2021. All the 13 Assays were registered in either College of American pathologist (CAP) or Royal college of pathologists of Australasia (RCPA) for Proficiency testing. Conclusion: The establishment of GCLP accredited laboratories and well-trained personnel has created centers of excellence and it has enabled them to attract independent competitive research funding. The GCLP accreditation and standardized testing procedures ensured reliable and accurate data, especially important for multi-country and multi-center studies.

Audit of bone marrow biopsy reports submitted to a myelodysplastic syndrome registry

Background: Reviewing a diagnosis of myelodysplastic syndrome (MDS) is challenging due to variability in morphological description and report content. Improved concordance in diagnosis may be achieved by adhering to morphological requirements based upon WHO classification criteria,1 and by following structured reporting guidelines. Aim: We reviewed bone marrow biopsy reports submitted to a pilot Myelodysplastic Syndromes Registry (MDSLink) to confirm accuracy of diagnoses based on morphological description, according to WHO 2016 criteria.1 We also audited report content according to the RCPA Bone Marrow Specimen Structured Reporting Protocol.2 Results: Out of 59 bone marrow biopsy reports reviewed, four (∼7%) cases did not describe morphological features consistent with the stated diagnoses based on WHO diagnostic criteria. Quantitative assessment of reported dysplasia (>/<10%) was infrequently provided, with qualitative terms more commonly used. Fifty-three reports complied with RCPA structured reporting guidelines, but six (∼11%) omitted details regarding trephine length, iron stores or presence and proportion of ring sideroblasts. WHO disease subtype was provided in all cases, but ICD-O code was rarely included (∼8%). Discussion: Reporting of morphological features in MDS according to WHO criteria in a structured format based on published guidelines allows objective confirmation and standardisation of MDS diagnoses, and identifies areas for improvement. 1.Swerdlow SH, Campo E, Harris NL, et al., editors. WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues. Revised 4th ed, 2016. Lyon: IARC, 2017.2.Royal College of Pathologists of Australasia (RCPA). Bone Marrow Specimen (Aspirate and Trephine Biopsy) Structured Reporting Protocol (1st Edition 2014). Sydney: RCPA, 2014. https://www.rcpa.edu.au/Library/Practising-Pathology/Structured-Pathology-Reporting-of-Cancer/Cancer-Protocols

Review of full blood count reference interval using a large cohort of first-time plasmapheresis blood donors

Full blood counts (FBC) are routinely performed on blood donors donating by apheresis. Australian Red Cross Lifeblood (Lifeblood) historically set FBC reference intervals (RIs) in alignment with standards of the Royal College of Pathologists of Australasia (RCPA). Recommendations now advise that RIs be developed locally to represent the population. This study analysed new blood donors' FBC results to inform a review of the current Lifeblood RIs. Retrospective analysis of routine laboratory data for first-time direct to plasmapheresis donations from 1 July 2018 to 30 June 2019 was conducted (n=15,710). FBC were performed using DxH 800 Haematology analysers. The 2.5% and 97.5% percentiles were compared with the current RIs and clinically significant variation informed adjustment. White blood cell and platelet parameters remained in alignment with RCPA reference intervals. The haemoglobin (Hb) RI for female donors reduced from 115-165 g/L to 113-147 g/L. For male donors, the upper limit for Hb required reduction from 185 g/L to 165 g/L. Red blood cell (RBC) counts and haematocrit (HCT) levels were lowered in this derivation from blood donors. Appropriate RIs allow for both the early detection of disease and avoid unnecessary investigation of otherwise healthy people. FBC analysis from current blood donors indicated changes were required to the RIs. The adjusted lower RBC and HCT values reduces the proportion of donors considered to have abnormal findings. The lower Hb limits will remain at 115 g/L in females and 125 g/L in males to align with regulatory requirements for blood donation.

The Royal College of Pathologists of Australasia (RCPA) position statement on COVID-19.

For the detection of early COVID-19 disease, RCPA supports the use of molecular tests for SARS-CoV-2 and strongly opposes the introduction of COVID-19 IgG/IgM rapid tests for this purpose.

Review of HER2 immunohistochemistry and in situ hybridisation concordance in breast cancer

As per current Royal College of Pathologists of Australasia (RCPA) recommendations for practice from the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2018 HER2 testing for breast cancer guidelines, routine HER2 in situ hybridisation (ISH) testing of immunohistochemistry (IHC) 0 or 1+ cases is not recommended. In light of the updated guidelines, we performed an audit of up to 4,000 cases from 2011–2019 at our institution with the aim of identifying discordance between IHC and ISH (single probe silver ISH, SISH; or dual probe fluorescence ISH, FISH). Of the 1,701 HER2 IHC 0 test results retrieved, 99.2% were HER2 SISH negative, 0.8% equivocal, and no SISH positive cases were identified. Of the IHC 0 and SISH equivocal cases, all were subsequently shown to be HER2 negative by further FISH testing. Of the 881 IHC 1+ test results, 96.7% were SISH negative, 3.0% equivocal, and 0.3% were positive. The majority of IHC 1+ cases with equivocal or positive SISH were ultimately shown to be HER2 negative by FISH. The IHC 1+ cases that were subsequently shown to be HER2 amplified by FISH were reviewed and some exhibited either tumour heterogeneity or were in the neoadjuvant setting. Our review supports the current recommendation against reflexive ISH testing of IHC 0 and 1+ cases, and referral for further testing in cases of tumour heterogeneity.

Post-mortem sexual assault examinations – What works, what doesn’t and our recommendations

Prior to 2013, doctors from the Sexual Assault Resource Centre (SARC) Perth were rarely asked to attend post-mortem examinations and then only when sexual assault/homicide was strongly suspected. Since the formation of the Faculty of Clinical Forensic Medicine (FCFM) within the Royal College of Pathologists of Australasia (RCPA) a much more collaborative approach between Forensic Pathology and SARC has been adopted. Forensic pathologists (and homicide detectives) are requesting SARC attendance at post-mortem examinations with increasing frequency. From 2013 onwards, SARC has performed 33 post-mortem examinations with ten being in 2019 to date. Led by a senior SARC doctor (FCFM Fellow) and applying Clinical Forensic Medicine principles, SARC doctors are gaining valuable experience in this specialised area. SARC examinations with forensic specimen collection have assisted in both the identification of genital injury and detection of spermatozoa respectively. SARC doctors have also advised on normal anatomical variants thus excluding suspicious injury. In this presentation the SARC model of service delivery will be discussed, highlighting what has been successful (and what has not) to the forensic pathologist, the police and to SARC.

Development, validation and application of an inductively coupled plasma – mass spectrometry method to determine cobalt in metal-on-metal prosthesis patients using volumetric absorptive microsampling

Metal-on-metal (MoM) prostheses, in which the bearing surfaces are made of a metal alloy, may release metal ions upon wear and corrosion, potentially inducing both local and systemic toxicity. As the systemic cobalt concentration increases with the degree of implant wear, this concentration needs to be monitored as a means of assessing implant function and the risk of adverse effects. Here, we report on the development, validation and application of a method to quantitatively assess these Co concentrations in whole blood, based on the combination of volumetric absorptive microsampling (VAMS) and inductively coupled plasma - mass spectrometry (ICP-MS). This method could allow patients to collect the required samples at home, as VAMS samples are easy to collect and can be transported to the laboratory via regular mail. The extraction procedure utilized an alkaline extraction mixture with yttrium as internal standard and proved to be independent of the hematocrit and age of the VAMS samples. The Co concentrations in the VAMS extracts were measured using quadrupole-based ICP-MS. The analytical method covers a range of 2–300 μg/L and displays excellent accuracy (bias ≤4%) and imprecision (relative standard deviation ≤ 5% and ≤15% at the lower limit of quantitation (LLOQ)). The method was applied to venous VAMS samples of MoM prosthesis patients (n = 78), yielding promising results. The comparison of these results with those obtained on the corresponding liquid whole blood samples, showed a correlation coefficient of 0.99 and 87% of the data fulfilled the criteria proposed by the Royal College of Pathologists of Australasia (RCPA).

An evidence- and risk-based approach to a harmonized laboratory alert list in Australia and New Zealand

Individual laboratories are required to compose an alert list for identifying critical and significant risk results. The high-risk result working party of the Royal College of Pathologists of Australasia (RCPA) and the Australasian Association of Clinical Biochemists (AACB) has developed a risk-based approach for a harmonized alert list for laboratories throughout Australia and New Zealand. The six-step process for alert threshold identification and assessment involves reviewing the literature, rating the available evidence, performing a risk analysis, assessing method transferability, considering workload implications and seeking endorsement from stakeholders. To demonstrate this approach, a worked example for deciding the upper alert threshold for potassium is described. The findings of the worked example are for infants aged 0-6 months, a recommended upper potassium alert threshold of >7.0 mmol/L in serum and >6.5 mmol/L in plasma, and for individuals older than 6 months, a threshold of >6.2 mmol/L in both serum and plasma. Limitations in defining alert thresholds include the lack of well-designed studies that measure the relationship between high-risk results and patient outcomes or the benefits of treatment to prevent harm, and the existence of a wide range of clinical practice guidelines with conflicting decision points at which treatment is required. The risk-based approach described presents a transparent, evidence- and consensus-based methodology that can be used by any laboratory when designing an alert list for local use. The RCPA-AACB harmonized alert list serves as a starter set for further local adaptation or adoption after consultation with clinical users.

The RCPA Quality Assurance Program in Dermatopathology: A Retrospective Review.

To review the Royal College of Pathologists of Australasia (RCPA) Quality Assurance Program Dermatopathology module from 2005 to 2016 to assess diagnostic performance, changes over time, and areas of diagnostic difficulty. The computerized records of the RCPA Dermatopathology subspecialist module were reviewed. Cases were categorized into groups including nonneoplastic disorders, neoplasms, and cases with multiple diagnoses. The performance of participants over time in each of these categories and in more specific areas (including melanocytic and adnexal neoplasms) was assessed. Cases which showed high rates of discordant responses were specifically reviewed. One hundred sixteen cases circulated over 10 years were evaluated. The overall concordance rate was 77%, with a major discordance rate of 7%. There was a slightly higher concordance rate for neoplasms compared with nonneoplastic lesions (80% vs. 74%). Specific areas associated with lower concordance rates included classification of adnexal tumors and identification of multiple pathologies. A spindle cell nevus of Reed yielded a 40% discordance rate, with most misclassifications indicating melanoma. The RCPA quality assurance program module has circulated a wide range of common and uncommon cases to participants over the 12 years studied, highlighting a low but important rate of major discordant responses. Melanocytic lesions, hematolymphoid infiltrates, adnexal tumors, and identification of multiple pathologies are identified as areas worthy of particular attention in quality improvement activities.

Driving structured reporting

The Royal College of Pathologists of Australasia (RCPA) has been running a structured pathology reporting program for cancer for almost a decade now and this represents an opportune time to assess the progress to date and the future directions for structured reporting. The key driving forces behind the move to structured (synoptic) reporting remain largely the same: published studies have demonstrated that structured reports provide more complete and accurate datasets for cancer management, research, clinical trials and cancer registries than traditional narrative pathology reports. However, the production of comprehensive structured reporting protocols for a wide range of cancers requires significant resourcing, including items such as pathologists' time, the employment of associated support staff and funding for face-to-face meetings and teleconferences. To address this, in 2011 the RCPA joined with the Royal College of Pathologists (UK), College of American Pathologists and the Canadian Association of Pathologists, to found the International Collaboration on Cancer Reporting (ICCR) with the aim of streamlining and harmonising the creation of pathology cancer datasets internationally. Development of RCPA protocols is now aligned with the publication of the ICCR datasets. This presentation will highlight upcoming cancer protocols as well as discuss the potential advantages inherent in electronic implementation.

Tuberculosis diagnostics in 2018

The National Tuberculosis Advisory Committee (NTAC) is publishing revised guidelines for Australian laboratories performing mycobacteriology testing. This revision has been through an extensive consultative peer-review process involving the Mycobacterium Reference Laboratory (MRL) network, the Mycobacterium Special Interest Group (SIG) of the Australian Society for Microbiology (ASM), the Royal College of Pathologists of Australasia (RCPA) and other relevant national bodies.