Quality Assurance Scheme Research Articles

Evaluation of analytical performance & quality specification of urine biochemical analytes

Urinary biochemical analytes are very important tools for clinical decision making. Total allowable error (TEa) by integrating internal (IQC) and external (EQC) quality control performances are used to evaluate the performance of urinary biochemical analytes along with quality specifications strategy. : Alternate 6 months Coefficient of Variation (CV%) and External Quality Assurance Scheme (EQAS) bias% data for urinary biochemistry analytes were collected for the year 2022. TEa calculated for each analyte was calculated based on average CV% and bias%. Total TEa calculated values are compared with optimal, minimal and desirable TEa of each analyte. : TEa values of urinary biochemistry analytes were performing good and fulfilled minimal, desirable and optimal quality requirements except urine creatinine which did not fulfill the minimal standards.: TEa is an excellent quality management tool and quantitatively evaluates analytical performance. The accurate results generated are useful for clinicians for decision-making.

Appeal from the European tuberculosis reference laboratory network (ERLTB-Net) for improving the diagnosis of infections due to nontuberculous mycobacteria

The European Reference Laboratory Network for tuberculosis (TB) (ERLTB-Net), comprising TB reference laboratories from 30 European Union/European Economic Area (EU/EEA) countries, was created in 2010 to support ECDC and countries in TB diagnostic services, alerts, and response to outbreaks. One of the core activities is to build capacity on standardised methods for mycobacterial diagnosis and antimicrobial susceptibility testing (AST) (https://www.ecdc.europa.eu/en/about-us/partnerships-and-networks/disease-and-laboratory-networks/erltb-net). ERLTB-Net recently identified weaknesses in capacity building of diagnosis and AST for non-tuberculous mycobacteria (NTM) [ [1] Nikolayevskyy V. Maurer F.P. Holicka Y. Taylor L. Liddy H. Kranzer K. Novel external quality assurance scheme for drug susceptibility testing of non-tuberculous mycobacteria: a multicentre pilot study. J Antimicrob Chemother. 2019; 74: 1288-1294 Crossref PubMed Scopus (6) Google Scholar ] and decided to draft guidance on best practices as well as to seek for research areas.

Recommended reference intervals for copper and zinc in serum using the US National Health and Nutrition Examination surveys (NHANES) data

Background and AimsIn view of the wide variations in reference intervals (RIs) for copper and zinc concentrations in serum, this study was designed to derive appropriate RIs that could be routinely adopted in other laboratories, so allowing better interpretation of results. A secondary aim was to assess the effects of several variables on serum concentrations of copper and zinc. Materials and MethodsData from over 21,000 individuals were downloaded from four National Health and Nutrition Examination Surveys conducted by the US Centers for Disease Control and Prevention. After controlling for the effects of several variables, age and gender-related RIs were calculated. ResultsA comprehensive list of reference intervals of copper and zinc in serum is provided.Serum copper concentrations were affected by age, gender, ethnicity, pregnancy, use of oral contraceptive pill, health status and smoking (in males). Serum zinc concentrations were affected by gender, age, fasting, ethnicity, serum albumin concentration, health status (in males), time of venipuncture and pregnancy. ConclusionReliable RIs for copper and zinc in serum were derived. As analytical accuracy and precision were assured and optimal sample collection protocols were followed, these RIs can be transferred for routine use in other clinical biochemistry laboratories with good analytical performance in external quality assurance schemes.

EQA: There's not a glitch in the matrix. Investigation of CRP bias on the Roche Cobas c701.

The Roche Cobas c Tina-quant C-Reactive Protein (CRP) IV method has shown persistent, significant negative bias compared to other methodologies in the UK NEQAS external quality assurance (EQA) scheme. The aim of this study was to compare CRP concentrations determined by this restandardized 4th generation assay with another commercially available method to assess the extent of any bias and impact on clinical cut-offs. CRP concentrations in 38 anonymized patient serum samples were determined by a particle-enhanced immunoturbidimetric assay on the Roche Cobas c701 module and a latex assay on the Beckman Coulter AU5800 analyser over a concentration range of 1-308mg/L. 97.4% samples analysed by the Roche Tina-quant CRP IV method demonstrated a negative bias compared to the Beckman AU latex method. The mean absolute bias was -4.12mg/L (range: -19.13-10.93mg/L; 95% CI: -17.25-9.01mg/L). The mean relative difference was -15.5% (range: -40-4%; 95% CI: -33.03-1.94%). This bias was seen across the range of samples assayed, including at clinically significant cut-offs of 5mg/L (-24% bias), 20mg/L (-5%) and 100mg/L (-13%). The negative bias of the Roche method demonstrated in the EQA scheme appears to reflect genuine differences in patient results, rather than an EQA matrix effect, despite re-standardization of the CRP assay. This report indicates that clinical cut-offs and reference ranges may be method-dependent, which should be reflected in published guidance and interpretation provided by laboratories.

External Quality Assurance Schemes (EQUASs) and Inter-laboratory Comparison Investigations (ICIs) for human biomonitoring of polycyclic aromatic hydrocarbon (PAH) biomarkers in urine as part of the quality assurance programme under HBM4EU

Polycyclic aromatic hydrocarbons (PAHs) were included as priority substances for human biomonitoring (HBM) in the European Human Biomonitoring Initiative (HBM4EU), which intended to harmonise and advance HBM across Europe. For this project, a specific Quality Assurance and Quality Control (QA/QC) programme applying Inter-laboratory Comparison Investigations (ICIs) and External Quality Assurance Schemes (EQUASs) was developed to ensure the comparability and accuracy of participating analytical laboratories. This paper presents the results of four ICI/EQUAS rounds for the determination of 13 PAH metabolites in urine, i.e. 1-naphthol, 2-naphthol, 1,2-dihydroxynaphthalene, 2-, 3- and 9-hydroxyfluorene, 1-, 2-, 3-, 4- and 9-hydroxyphenanthrene, 1-hydroxypyrene and 3-hydroxybenzo(a)pyrene. However, 4 PAH metabolites could not be evaluated as the analytical capacity of participating laboratories was too low. Across all rounds and biomarkers, 86% of the participants achieved satisfactory results, although low limits of quantification were required to quantify the urinary metabolites at exposure levels of the general population. Using high-performance liquid or gas chromatography coupled with mass spectrometry (HPLC-MS; GC-MS) and isotope dilution for calibration as well as performing an enzymatic deconjugation step proved to be favourable for the accurate determination of PAHs in urine. Finally, the HBM4EU QA/QC programme identified an international network of laboratories providing comparable results in the analysis of urinary PAH biomarkers, although covering all parameters initially selected was still too challenging.

Guideline on the investigation and management of acute transfusion reactions.

Guideline on the investigation and management of acute transfusion reactions.

Consumers' willingness to pay for an animal welfare food label

Consumers increasingly rate the ethical dimensions of food production, including animal welfare, as important to them but how these concerns influence their food choices remains unclear. To address this, a Discrete Choice Experiment assesses consumers' willingness to pay for chicken meat. The study aims to understand the effects of food labels (RSPCA Assured and Red Tractor), cause-related marketing campaigns, and price on consumers' willingness to pay. Drawing on a representative sample of 401 British consumers, we estimate a mixed logit model using the hierarchical Bayesian estimation method. The results for the full sample reveal a substantial price premium associated with the animal welfare label (RSPCA Assured); however, this is less pronounced than one of the cause-related marketing campaigns. A latent class analysis identifies two distinct market segments, price sensitive and concerned consumers, which differ on socio-economic and behavioural characteristics. Amongst price sensitive consumers, willingness to pay extra for an animal welfare label is negligible. Complementary, qualitative interviews reveal consumers' difficulties in comparing the varying standards that underpin quality assurance schemes.

Quality Measurement for Soft Tissue Sarcomas in Germany: First Results of the Certified Sarcoma Centres

Introduction: Soft tissue sarcomas (STSs) are rare diseases. A high level of standardization and centralization was lacking in Germany until 2018. Methods: By developing an evidence-based guideline and a certification system for sarcoma centres, foundations for structured, guideline-based, and centralized sarcoma care were defined. First results of the certified sarcoma centres are presented. Results: The first 3 years of data collection show good results for case volume, presentation rates in pretherapeutic and postoperative tumour boards, psycho-oncological counselling, and study rates. However, other indicators (e.g., preoperative or postoperative radiotherapy for operated high-risk STS without GIST, counselling rates social services) still have potential for improvement. Based on these results, the set of indicators could be further improved. Conclusions: A sarcoma-specific quality assurance scheme that includes guideline-derived quality indicators was developed. In future, a broader database will allow further insights into sarcoma care in Germany.

No time for improvement? The chronopolitics of quality assurance

Time is an omnipresent key dimension in everyone’s life, yet academic time has only recently found scholarly attention. The temporal aspects of quality assurance, in particular, are basically unchartered territory. Taking a chronopolitical perspective, this article aims to close the gap, by critically examining how temporalities are firmly embedded in many quality assurance schemes and routines. Using various examples from internal and external quality assurance, the author demonstrates and discusses how such mechanisms are not only binding time but regulating and governing it, imposing temporal norms regarding tempo, rhythm, time-spans, time-scales and time ownership on higher education institutions and the people working and learning there. Concludingly, the article advocates a more reflective approach towards the notion of time in quality assurance, as latent temporalities appear to be far more consequential for the effectiveness of quality assurance than methodological micro-differences.

Performance of parasite QAP in Australia and New Zealand

In many laboratories, microscopy still remains the cornerstone of parasitological diagnostics and provides an epidemiological assessment of parasite burden. High-quality diagnostic service includes participation in an external quality assurance (EQA) scheme to help measure the quality of the service.

Survey of liver pathologists to assess attitudes towards digital pathology and artificial intelligence

AimsA survey of members of the UK Liver Pathology Group (UKLPG) was conducted, comprising consultant histopathologists from across the UK who report liver specimens and participate in the UK National...

Using three external quality assurance schemes to achieve equivalent international normalized ratio results in primary and secondary healthcare

Accurate prothrombin time international normalized ratio (INR) results are essential for safe anticoagulation treatment. Patients are treated both in primary and secondary healthcare, therefore equivalence of INR results from point-of-care (POC) and hospital measurement procedures (MPs) are important. It is not possible to evaluate this equivalence in traditional external quality assessment (EQA). The aim of this paper is to describe a special quality assurance system consisting of three different EQA schemes to monitor the harmonization of INR results in Norway. The EQA scheme for hospital laboratories uses commutable control materials and evaluates participant performance and the equivalence of hospital MPs. The EQA scheme for primary healthcare laboratories uses non-commutable control materials and evaluates participant performance. A third EQA scheme for selected primary healthcare laboratories uses native patient split samples and evaluates the equivalence between POC and hospital MPs. The relationship between the three EQA schemes ispresented. The split sample EQA scheme provides a link between the hospital scheme and the scheme for primary healthcare. Results from 2017 to 2022 are presented for all three schemes. When aberrant EQA results occur Noklus takes actions to be able to have a sustainable equivalence between INR results. All three EQA schemes are important for monitoring the harmonization of INR results in Norway. This quality assurance system, including help and guidance of the participants, will reduce the risk of harm to patients due to non-equivalence of results from different MPs.

Establishing an External Quality Assessment (EQA) Program for Urinalysis in Medical Laboratories of Thailand.

Thailand Association of Clinical Biochemists (TACB) introduced External Quality Assurance schemes (EQAs) for urinalysis (UA) using urine strips in medical laboratories of Thailand. The few available External Quality Assessment (EQA) programs on urinary microalbumin rarely include an evaluation of clinical cases. The aim of the present study was to assess a descriptive analysis of biochemical urinalysis including urine microalbumin in the Thailand laboratory practice. From January 2021 to December 2021, four surveys were organized. EQA urine samples were distributed to the participants by mail. The participants measured the UA of 2 samples quarterly and returned the results together with the information about their instruments and suggestion for the performance of the laboratory report quarterly. Moreover, summary of the situation of each laboratory performance was feedbacked by online system. Fifty-eight laboratories participated in the survey. The EQA panels included positive and negative samples. The analytical results for passed parameters of urine chemical test range from 79.3-100%. All special tests; microalbumin, creatinine, and beta-HCG showed correct result from 85.1-96.1%. The overall accuracy, specificity, and sensitivity were 92.6, 85.7, and 75,4%, respectively. The major issues were observed: the low sensitivity for the detection of low-concentration samples and the incapacity of several methods to detect the positive sample. The assessment is needed to continuously evaluate the improvement proficiency of laboratories in Thailand.

SDN-based band-adaptive quality assurance scheme in support of heterogenous B5G services over sliceable multi-band optical networks

The rise of traffic intensive services and applications is pushing the limits of conventional single band Wavelength Division Multiplexing (WDM) optical networks. As an answer to this challenge, new data plane technologies are being investigated. Multi-band optical networks have raised as a very interesting candidate due to the potential increased capacity they offer thanks to the exploitation of multiple bands of the optical spectrum. Considering the whole telecom ecosystem, multi-band optical networks will coexist with other technological segments (e.g., Radio Access Network (RAN)) with the aim of provisioning services across the end-to-end infrastructure. With the advent of 5G and beyond 5G (B5G) architectures, novel provisioning paradigms are taking preponderance, such as the case of network slicing, which represents a radical paradigm change with respect to legacy business and provisioning models. As such, proper solutions for supporting network slice provisioning and runtime maintenance at the data plane are required. With this in mind, in this paper we present a control and orchestration architecture for the configuration and maintenance of network slices in multi-band optical networks, in support of B5G end-to-end services. Indeed, quality assurance and maintenance at all levels is seen as a cornerstone in B5G architectures. Thus, proper mechanisms adapted to the nature of the underlying sliceable multi-band data plane are required to ensure the quality of deployed slices. In this regard, we also present a novel band-adaptive protection scheme which takes advantage of the properties of the multi-band data plane so as to enhance the robustness of slices against quality degradations. We showcase the provisioning and maintenance of multi-band optical network slices by means of an experimental demonstration in a real testbed deployed at our premises. In addition, we evaluate the performance of the proposed band-adaptive protection scheme for slice quality assurance in front of other strategies by means of extensive simulation analysis in larger network scenarios.

Recommendations for laboratory testing of UK patients with acute myeloid leukaemia.

Recommendations for laboratory testing of UK patients with acute myeloid leukaemia.

Frontiers in Breast Pathology.

Frontiers in Breast Pathology.

Access and quality of biomarker testing for precision oncology in Europe

BackgroundPredictive biomarkers are essential for selecting the best therapeutic strategy in patients with cancer. The International Quality Network for Pathology, the European Cancer Patient Coalition and the European Federation of Pharmaceuticals Industries and Associations evaluated the access to and quality of biomarker testing across Europe. MethodsData sources included surveys of 141 laboratory managers and 1.665 patients, and 58 in-depth interviews with laboratory managers, physicians and payers. Four access metrics (laboratory access, test availability, test reimbursement, test order rate) and three quality metrics (quality scheme participation, laboratory accreditation, test turnaround time) were applied to rank the results. ResultsThe access to precision medicines is higher in countries with public national reimbursement processes in place. Lack of diagnostic laboratory infrastructure, inefficient organization and/or insufficient public reimbursement narrow the access to single biomarker tests in many European countries. In countries with limited public reimbursement, pharma and patients’ out of pocket were the primary funding sources for testing. Uptake of multi-biomarker next generation sequencing (NGS) is highly varied, ranging from 0% to >50%. Financial constraints, a lack of NGS testing capabilities and the failure to include NGS testing in the guidelines represent the main barriers to NGS implementation. The quality of biomarker testing is highest in Western and Northern Europe, with more than 90% of laboratories participating in quality assurance schemes. ConclusionsOur data clearly indicate the need for a call to action to ensure the clinical implementation of precision medicine in Europe.

Laboratory policies and practices for thyroid function tests in Croatia: survey on behalf of Working Group for Laboratory Endocrinology of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

IntroductionLaboratory plays important part in screening, diagnosis, and management of thyroid disorders. The aim of this study was to estimate current laboratory preanalytical, analytical and postanalytical practices and policies in Croatia.Materials and methodsWorking Group for Laboratory Endocrinology of the Croatian Society of Medical Biochemistry and Laboratory Medicine designed a questionnaire with 27 questions and statements regarding practices and protocols in measuring thyroid function tests. The survey was sent to 111 medical biochemistry laboratories participating in external quality assurance scheme for thyroid hormones organized by Croatian Centre for Quality Assessment in Laboratory Medicine. Data is presented as absolute numbers and proportions.ResultsFifty-three participants returned the questionnaire. Response rate varied depending on question, yielding a total survey response rate of 46-48%. All respondents perform thyroid stimulating hormone (TSH). From all other thyroid tests, most performed is free thyroxine (37/53) and least TSH-stimulating immunoglobulin (1/53). Laboratories are using nine different immunoassay methods. One tenth of laboratories is verifying manufacturer’s declared limit of quantification for TSH and one third is verifying implemented reference intervals for all performed tests. Most of laboratories (91%) adopt the manufacturer’s reference interval for adult population. Reference intervals for TSH are reported with different percentiles (90, 95 or 99 percentiles).ConclusionThis survey showed current practices and policies in Croatian laboratories regarding thyroid testing. The results identified some critical spots and will serve as a foundation in creating national guidelines in order to harmonize laboratory procedures in thyroid testing in Croatia.

Quality assurance programs to support tuberculosis diagnostic capacity amongst laboratories within Meru county, Kenya

Background: According to the Kenya Ministry of Health, Meru County had reported a tuberculosis (TB) notification rate of 158/100,000 population in 2015. Aforementioned reports indicates that the prevalence of TB that warrants early detection and diagnosis, hence the need to determine quality assurance programs to Support tuberculosis diagnostic capacity of Tuberculosis amongst laboratories within Meru County. Objective: To determine quality assurance programs to support tuberculosis diagnostic capacity amongst laboratories within Meru County, Kenya. Materials and Methods: This was a descriptive study survey which utilized quantitative techniques to establish the potential and capacity of laboratory personnel in TB diagnostic laboratories in selected medical centres. Data entry was done through use of Statistical Package for Social Sciences (SPSS). Frequency and percentages were calculated. Findings were presented in form of frequency distribution tables and bar graphs and analyzed using Chi square. Results: Majority of laboratory personnel had indicated that their laboratories were public laboratories (69.2%) followed by private owned laboratories (30.8%). There were significant differences in the diagnostic capacity of TB between public and private owned laboratories in relation to availability of the following resources: Safety cabinet [χ2 (1 df, N= 26) = 18.49, p=0.000<0.05], Centrifuge [χ2 (1 df, N= 26) = 10.64, p=0.000<0.05], Gene Xpert resources [χ2 (1 df, N= 26) = 18.49, p=0.000<0.05], Freezer/refrigerator [χ2 (1 df, N= 26) = 14.28, p=0.000<0.05], Incubator [χ2 (1 df, N= 26) = 18.49, p=0.000<0.05] and TB florescence microscopy [χ2 (1 df, N= 26) = 18.49, p=0.000<0.05]. Majority of the respondents had been using Centre of Disease Control and Prevention (CDC) as their quality assurance schemes (61.5%) followed by Central TB reference laboratories, Ministry of Health (26.9%) and (others please specify) who never participated in any quality assurance scheme (11.5%). majority of respondents had been sending their specimens for TB culture and sensitivity to research institution (KEMRI Centre for Respiratory Diseases) (69.2%), followed by those who indicated ‘Any other’ thus not sending any specimen for TB culture and sensitivity (26.9%) and to private or commercial laboratories (3.8%). None of the respondents had indicated sending their specimens for TB culture and sensitivity to either Central TB Reference laboratories Q/A (ministry of health) or a university (0.0%).

Practical application of European biological variation combined with Westgard Sigma Rules in internal quality control.

Westgard Sigma Rules is a statistical tool available for quality control. Biological variation (BV) can be used to set analytical performance specifications (APS). The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) regularly updates BV data. However, few studies have used robust BV data to determine quality goals and design a quality control strategy for tumor markers. The aim of this study was to derive APS for tumor markers from EFLM BV data and apply Westgard Sigma Rules to establish internal quality control (IQC) rules. Precision was calculated from IQC data, and bias was obtained from the relative deviation of the External quality assurance scheme (EQAS) group mean values and laboratory-measured values. Total allowable error (TEa) was derived using EFLM BV data. After calculating sigma metrics, the IQC strategy for each tumor marker was determined according to Westgard Sigma Rules. Sigma metrics achieved for each analyte varied with the level of TEa. Most of these tumor markers except neuron-specific enolase reached 3σ or better based on TEamin. With TEades and TEaopt set as the quality goals, almost all analytes had sigma values below 3. Set TEamin as quality goal, each analyte matched IQC muti rules and numbers of control measurements according to sigma values. Quality goals from the EFLM BV database and Westgard Sigma Rules can be used to develop IQC strategy for tumor markers.