Clinical chemistry and laboratory medicine最新文献

{"title":"EN ISO 15189 revision: EFLM Committee Accreditation and ISO/CEN standards (C: A/ISO) analysis and general remarks on the changes.","authors":"Solveig Linko, Guilaine Boursier, Francisco A Bernabeu-Andreu, Nana Dzneladze, Florent Vanstapel, Pika Meško Brguljan, Katerina Tosheska-Trajkovska, Hélène Mehay, Mauro Panteghini, Duilio Brugnoni, Neda Milinkovic, Maria Lohmander, Luděk Šprongl, Hikmet Can Çubukçu, Marc Thelen","doi":"10.1515/cclm-2024-1451","DOIUrl":"https://doi.org/10.1515/cclm-2024-1451","url":null,"abstract":"<p><p>The EN ISO 15189:2022 standard, titled \"Medical laboratories - Requirements for quality and competence,\" is a significant update to the regulations for medical laboratories. The revised standard was published on December 6, 2022, replacing both EN ISO 15189:2012 and EN ISO 22870:2016. Key objectives of the revision include: 1. Alignment with ISO/IEC 17025:2017, 2. Removal of unintended prescription, 3. Focus on patient interest and safety, 4. Minimization of new requirements, and 5. Improved clarity of text. Dedicating to harmonizing accreditation processes across Europe the EFLM Committee on Accreditation and ISO/CEN standards (C: A/ISO) has produced this guidance document to assist the laboratory medicine community in understanding and implementing the criteria of the EN ISO 15189 revision. Two main objectives of the guidance in educating both laboratories and accreditation bodies with their assessors as well as other stakeholders in laboratory medicine were agreed on. Firstly, to clarify the relevant changes covering all paragraphs of the standard and secondly to make an impact analysis on previous C: A/ISO guidance documents.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142925955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Blood samples for ammonia analysis do not require transport to the laboratory on ice: a study of ammonia stability and cause of <i>in vitro</i> ammonia increase in samples from patients with hyperammonaemia.","authors":"Gavin W Mercer-Smith, Marie Appleton, Élodie A Hanon, Ann Bowron","doi":"10.1515/cclm-2024-1304","DOIUrl":"https://doi.org/10.1515/cclm-2024-1304","url":null,"abstract":"<p><strong>Objectives: </strong>Prompt recognition of hyperammonaemia can avoid severe consequences of delayed treatment. Strict sample transport requirements present barriers to requesting and, if not achieved, rejection by the laboratory. Evidence is sparse on <i>in vitro</i> ammonia stability from studies using modern techniques or based in clinical settings. Stability in hyperammonaemic samples is unknown. This study aimed to examine ammonia stability and its source in samples from hyperammonaemic patients and to determine a clinically significant change to establish acceptable sample requirements for ammonia analysis.</p><p><strong>Methods: </strong>Blood samples were taken from 19 hyperammonaemic patients and placed either on ice or kept at room temperature. Plasma ammonia was measured every 10 min for 2 h. Haemolysis index (HI), full blood count, liver enzymes and amino acids were analysed. Expert physicians were surveyed on a clinically significant ammonia change. Stability was assessed using the reference change value (RCV).</p><p><strong>Results: </strong>Ammonia increased with time [peak value 14.9 % (8.4-17.1), median (95 % confidence interval)], and was predominately of cellular origin. Ice did not improve stability and increased HI. Survey results found a significantly increased ammonia between 39 % (30-48) at 50 μmol/L and 21 % (15-28) at 1,000 μmol/L. Ammonia RCV was 40.8 %.</p><p><strong>Conclusions: </strong>Chilling samples did not improve blood ammonia stability. The increase in blood ammonia from patients with hyperammonaemia over 2 h was lower than that considered clinically significant and the calculated RCV. Transport of samples for ammonia analysis does not require ice and laboratories should accept samples if received within 2 h of venepuncture.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926814","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Refining within-subject biological variation estimation using routine laboratory data: practical applications of the refineR algorithm.","authors":"Eirik Åsen Røys, Kristin Viste, Christopher-John Farrell, Ralf Kellmann, Nora Alicia Guldhaug, Elvar Theodorsson, Graham Ross Dallas Jones, Kristin Moberg Aakre","doi":"10.1515/cclm-2024-1386","DOIUrl":"10.1515/cclm-2024-1386","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142902776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Verification of automated review, release and reporting of results with assessment of the risk of harm for patients: the procedure algorithm proposal for clinical laboratories.","authors":"Marijana Miler, Nora Nikolac Gabaj, Gordan Šimić, Adriana Unić, Lara Milevoj Kopčinović, Marija Božović, Anita Radman, Alen Vrtarić, Mario Štefanović, Ines Vukasović","doi":"10.1515/cclm-2024-1164","DOIUrl":"https://doi.org/10.1515/cclm-2024-1164","url":null,"abstract":"<p><strong>Objectives: </strong>Autoverification increases the efficiency of laboratories. Laboratories accredited according to ISO 15189:2022 need to validate their processes, including autoverification, and assess the associated risks to patient safety. The aim of this study was to propose a systematic verification algorithm for autoverification and to assess its potential risks.</p><p><strong>Methods: </strong>The study was conducted using retrospective data from the Laboratory Information System (LIS). Seven laboratory medicine specialists participated. Autoverification rules were defined for analytes in serum, stool, urine and whole blood determined on Alinity ci (Abbott), Atellica 1500 (Siemens) and ABL90 FLEX (Radiometer). Criteria included internal quality control results, instrument flags, hemolysis/icteria/lipemia indices, median patient values, critical values, measurement ranges, delta checks, and reference values. Verification was performed step by step. Risk analysis was performed using Failure Modes and Effects Analysis and the Risk Priority Number (RPN) was calculated.</p><p><strong>Results: </strong>During the study, 23,633 laboratory reports were generated, containing 246,579 test results for 167 biochemical tests. Of these, 198,879 (80.66 %) met the criteria for autoverification. For 2,057 results (0.83 %), the experts disagreed with the autoverification criteria (false negatives). Discrepancies were mainly associated to median and delta check values. Only 45 false positives (0.02 %) were identified, resulting in an RPN of 0 for all cases.</p><p><strong>Conclusions: </strong>The autoverified and non-autoverified results showed high agreement with the expert opinions, with minimal disagreement (0.02 % and 0.83 %, respectively). The risk analysis showed that autoverification did not pose a significant risk to patient safety. This study, the first of its kind, provides step-by-step recommendations for implementing autoverification in laboratories.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142902778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sigma Metrics misconceptions and limitations.","authors":"Xincen Duan, Elvar Theodorsson, Wei Guo, Tony Badrick","doi":"10.1515/cclm-2024-1380","DOIUrl":"https://doi.org/10.1515/cclm-2024-1380","url":null,"abstract":"<p><strong>Objectives: </strong>This paper further explores the Sigma Metric (SM) and its application in clinical chemistry. It discusses the SM, assay stability, and control failure relationship.</p><p><strong>Content: </strong>: SM is not a valid measure of assay stability or the likelihood of failure. When an out-of-control event occurs for an assay with a higher SM value, the same QC rule will have greater power to detect error than assays with a lower SM value. Thus, it is easier to prevent errors from happening for higher SM assays. This rationale encourages using more frequent QC events and more QC samples for a QC scheme of a low SM assay or simply more QC cost for low SM assays. A laboratory can have a high-precision instrument that frequently fails and a low-precision instrument that hardly ever fails. Parvin's patient risk model presumes the bracketed continuous mode (BCM) testing workflow. If overlooked when designing QC schemes, this leads to the common misconception of the SM that one can save the cost of QC since assays with high SM require less frequent QC to ensure patient risk. There is no evidence that an assay's precision is correlated with its failure rate. Schmidt et al., in a series of papers, showed that an assay with a higher P_f or shift in probability will have a higher expected number of unacceptable results. Incorporating P_f into the QC design process presents significant challenges despite the proactive quality control (PQC) methodology.</p><p><strong>Summary: </strong>Unfortunately, TEa Six Sigma, as widely practiced in Clinical Chemistry, is not based on classical Six Sigma mathematical statistics. Classical Six Sigma would facilitate comparing results across activities where the principles of Six Sigma are employed.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health literacy: a new challenge for laboratory medicine.","authors":"Federico Pennestrì, Giuseppe Banfi","doi":"10.1515/cclm-2024-1158","DOIUrl":"https://doi.org/10.1515/cclm-2024-1158","url":null,"abstract":"<p><p>Poor health literacy and inappropriate test prescribing hamper the value of laboratory medicine. The disintermediation between test producers and interpreters may happen both in Point of Care Tests, where doctor mediation is provided, but laboratory expert supervision is not, and in Direct to Consumer Testing, where no medical mediation is provided at all. In these cases, the respect for patient's autonomy must not preclude the principles of non-maleficence (as an individual concern) and justice (as a societal concern), as wrong test interpretation can generate confusion, anxiety, inappropriate social behavior, useless medical examinations and considerable cost increase. Considering how different is patient ability to understand test results (if any) and handle any physical and psychological consequence, promoting health literacy and professional laboratory mediation become crucial professional priorities. The aims of this review are 1) to describe the importance of health literacy on laboratory test interpretation, medical advice and therapeutic compliance; 2) to discuss doctor-level, patient-level and caregiver-level educational interventions in light of the four principles of the value-based framework (personal value, technical value, allocative value and societal value). Based on these premises, the authors support the need to enhance health literacy in patients, help doctors improve the communication of results and validate commercial tests under the scrutiny of scientific community.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142812292","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CD34+ progenitor cells meet metrology.","authors":"Bruno Brando, Arianna Gatti","doi":"10.1515/cclm-2024-1330","DOIUrl":"https://doi.org/10.1515/cclm-2024-1330","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142681001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Allowable total error in CD34 cell analysis by flow cytometry based on state of the art using Spanish EQAS data.","authors":"Sara Fernández-Luis, Alejandra Comins-Boo, Fernando Pérez-Pla, Juan Irure-Ventura, Andrés Insunza Gaminde, Marcos López-Hoyos, Lydia Blanco-Peris, M Carmen Martín Alonso, David San Segundo Arribas","doi":"10.1515/cclm-2024-0956","DOIUrl":"10.1515/cclm-2024-0956","url":null,"abstract":"<p><strong>Objectives: </strong>CD34+ hematopoietic stem cell (HSC) enumeration, crucial for HSC transplantation, is performed by flow cytometry to guide clinical decisions. Variability in enumeration arises from biological factors, assay components, and technology. External quality assurance schemes (EQAS) train participants to minimize inter-laboratory variations. The goal is to estimate total error (TE) values for CD34 cell enumeration using state-of-the-art (SOTA) methods with EQA data and to define quality specifications by comparing TE using different cutoffs.</p><p><strong>Methods: </strong>A total of 3,994 results from 40 laboratories were collected over 11 years (2011-2022) as part of the IC-2 Stem Cells Scheme of the GECLID Program that includes absolute numbers of CD34 cells. The data were analyzed in two periods: 2011-2016 and 2017-2022. The TE value achieved by at least 60 %, 70 %, 80 %, and 90  % of laboratories was calculated across the two different periods and at various levels of CD34 cell counts: above 25, 25 to 15, and under 15 cells/μL.</p><p><strong>Results: </strong>A decrease in the SOTA-based TE for CD34 cell enumeration was observed in the most recent period in 2017-2021 compared with 2012-2016. A significant increase of P75 TE values in the low CD34 range (<15 cells/μL) levels was found (p<0.001).</p><p><strong>Conclusions: </strong>Technical advancements contribute to the decrease TE over time. The TE of CD34 cell FC counts is measure-dependent, making it responsive to precision enhancement strategies. The TE measured by EQAS in this study may serve as a quality specification for implementing ISO 15189 standards in clinical laboratories for CD34 cell enumeration.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616107","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reviewer Acknowledgment.","authors":"","doi":"10.1515/cclm-2024-2001","DOIUrl":"https://doi.org/10.1515/cclm-2024-2001","url":null,"abstract":"","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616128","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clostebol and sport: about controversies involving contamination vs. doping offence.","authors":"Pascal Kintz, Laurie Gheddar, Simona Pichini, Mario Plebani, Alberto Salomone","doi":"10.1515/cclm-2024-1165","DOIUrl":"https://doi.org/10.1515/cclm-2024-1165","url":null,"abstract":"<p><p>Clostebol, the 4-chloro derivative of testosterone, available as Over The Counter product in pharmacies and drugstores in several countries, is mostly commercialized as a cream or spray in the form of acetate ester. As other anabolic steroids, clostebol is listed as a prohibited substance by the World Anti-Doping Agency (WADA). Controlled transdermal application of clostebol acetate has been reported to produce detectable amounts of its metabolites in urine, even after a single exposure. Indeed, a low urine concentration can be interpreted as the tail of a drug voluntarily used to enhance performance or a direct consequence of a contamination. The increased number of adverse analytical findings (AAFs) involving clostebol reported in the last years should lead to highlight the need for athletes to be warned against personal and /or accidental use/exposure of dermal preparation containing this doping agent. Further discussion on possible threshold limits and laboratory testing on different matrices (e.g. hair) to better clarify the origin of minimal amounts of clostebol in urines is advisable.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142459545","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}