1,721,081 research outputs found
Biological variation: Understanding why it is so important?
No full textThis Review will describe the increasing importance of the concepts of biological variation to clinical chemists. The idea of comparison to ‘reference’ is fundamental in measurement. For the biological measurands, that reference is the relevant patient population, a clinical decision point based on a trial or an individual patient's previous results. The idea of using biological variation to set quality goals was then realised for setting Quality Control (QC) and External Quality Assurance (EQA) limits. The current phase of BV integration into practice is using Patient-Based Real-Time Quality Control (PBRTQC) and Patient Based Quality Assurance (PBQA) to detect a change in assay performance. The challenge of personalised medicine is to determine an individual reference interval. The Athletes Biological Passport may provide the solution.Full Tex
Methods for determining clinical utility
No full textMeasuring the clinical utility of a diagnostic test involves evaluating its impact on patient outcomes, clinical decision-making, and healthcare resource utilization. Determining clinical utility requires accessing patient medical history and outcomes data. These studies involve enrolling patients undergoing diagnostic tests and tracking their clinical outcomes. Researchers can determine the test's clinical utility by comparing the outcomes of patients who receive the diagnostic test to those who do not. These outcomes include benefits and harm. The highest level of evidence to support clinical utility determinations may be obtained from clinical trials. However, clinical laboratories are often not involved in clinical trials, and laboratory specialists may not be experienced in conducting such trials. Many established laboratory tests have never had clinical utility determined. Prospective studies assessing a diagnostic test's impact on clinical outcomes may require long-term patient monitoring, which is problematic. This paper presents methods that may be used to assess clinical utility.No Full Tex
The carbon footprint of pathology testing (Letter)
No full textTo the Editor: The recently published article by McAlister and colleagues1 highlights the importance of health care organisations becoming aware of their environmental impact. However, there are several misconceptions inherent in the analysis.No Full Tex
Down under EQA
No full textThe Royal College of Pathologists of Australasia Quality Assurance Programs (QAP) is the leading supplier of EQA programs in Australasia as well as providing EQA to over 80 countries. The QAP provides programs in Chemical Pathology, Hematology, Microbiology, Anatomical Pathology, Cytopathology, Molecular Genetics, Serology, Immunology, Point of Care, and Biosecurity. There is an emphasis on education and a large number of workshops are conducted by the QAP to provide support for participants in EQA interpretation and quality improvement. The organization is accredited to ISO 9001, ISO 17043, ISO 45001, and ISO 14001. The QAP has been offering programs for over thirty years and has developed a range of unique programs in each discipline.No Full Tex
Harmonising EQA schemes the next frontier: Challenging the status quo
No full textThere 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. The path ahead for harmonisation of EQA schemes will require leadership from an organisation that has the support and confidence of EQA providers, like the European Organisation for External Qualily Assurance Providers in Laboratory Medicine.No Full Tex
Integrating patient-based quality control and patient-based quality assurance
No full textLaboratory medicine produces objective data that healthcare workers interpret to aid clinical decision-making. Reliable laboratory results are required to avoid erroneous clinical decision-making. Internal quality control (IQC) and external quality assurance (EQA) are the primary tools used in clinical laboratories to reduce patient risk. An ideal quality monitoring tool should provide laboratory practitioners feedback regarding an error onset before the laboratory results can affect patient care. However, this is often challenging with the episodic nature of IQC and EQA testing.No Full Tex
Real time patient QC - Middleware requirements and model validation
No full textPatient Based Real Time Quality Control (PBRTQC) techniques are becoming practical alternatives for many clinical chemistry assays because of commutability, greater sensitivity at detecting bias changes, application to pre-analytical error detection, and cost-effectiveness. For PBRTQC to be effective and assay performance to be continuously monitored, laboratory data needs to be extracted and analyzed in real-time by the algorithm within the middleware of LIS. There should be an ability to reset the algorithm and exclusion of specific patients after a workup of the alarm. Many analytical platforms will likely have onboard PBRTQC applications, but there will still be a need for laboratories to optimize and validate this middleware. There are several measures of performance for PBRTQC, including power function analysis, total error allowable (TEa) detection probability, average or median number of patient result affected before error detection (ANPed or MNPed), sensitivity/specificity of error detection, bias detection curves and the number of patient results required to detect error with a given probability. The performance verification of PBRTQC can be undertaken by in silico analysis. This can be performed without incurring a high cost beyond the human resources and computational power required. To perform simulations, a set of representative patient data should be collected. It is often easier to use computer-based simulation where the actual patient population is used, adding varying levels of additional bias and block sizes to gauge the ability of the algorithm to detect the error while releasing as few erroneous patient results as possible.No Full Tex
Progressing the certification of the medical science workforce
No full textThe Australian Commonwealth Government has funded a project to investigate options for a sustainable certification scheme for medical laboratory scientists (MLSs). This has been a sought-after goal for the profession in Australia for many years. Certification is not registration as certification may not be mandatory and does not have the legal teeth of the more formal process. Models of overseas registration schemes are discussed and the key features exposed. The definition of an MLS is needed as certification will provide protection of the title. What are the basic requirements for certification and recertification, what could the process be, the likely cost and period of validity? An essential component of the certification process would be some form of continuing professional development, but it is suggested that there should be a broader requirement for competence assessment for recertification. How this process could occur and be linked to the competency-based standards endorsed by the Pathology Associations Council is canvassed. The connection between certification and course accreditation should also be considered if courses are to provide work-ready MLSs in sufficient numbers to ensure the workforce can provide the necessary skills for the protection of the public.Full Tex
The carbon footprint of pathology testing (Letter)
No full textTo the Editor: The Royal College of Pathologists of Australasia (RCPA) is concerned with some of the conclusions drawn in the article by McAlister and colleagues.1 We support the suggestion that there are opportunities for reducing waste and carbon dioxide emissions in pathology laboratories and, with the RCPA Quality Assurance Programs, we encourage laboratories to reduce their environmental impact whenever possible. There are laboratories already active in this space.2, 3 Furthermore, we unequivocally support and encourage clinicians to exercise due consideration in choosing appropriate pathology tests. However, the reduction of pathology testing purely to reduce carbon footprint brings significant public health and economic consequences to the community.No Full Tex
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