Risk analysis of the preanalytical process based on quality indicators data.

Abstract:

BACKGROUND:Improving quality and patient safety in the medical biochemistry laboratory accredited according to the International Standard Organization (ISO 15189:2012) requires the patient-centered evaluation of errors based on the implementation of quality indicators (QIs) across the total testing process. Our main goal was to achieve quality improvement of the preanalytical process in an emergency laboratory which had the highest error rate using risk management principles. METHODS:Failure mode and effects analysis (FMEA) was applied to analyze predefined preanalytical QIs and score laboratory failures for the failure demerit value (FDV), probability of failure (PF) and probability of failure remedy (PFR). Based on obtained scores (on a 10-point scale) risk priority numbers (RPNs) were calculated. RESULTS:A total of five failure modes were identified in the preanalytic process. The calculated risks were "sample hemolysis" (RPN, 168),"misidentified samples" (RPN, 108),"samples clotted" (RPN, 90),"sample volume error" (RPN, 72) and "samples transported at inappropriate temperature" (RPN, 24). The activation of corrective risk-reducing measures for failure modes with RPN≥30 resulted in quality improvement with the significant decrease in reevaluated RPNs. CONCLUSIONS:The implementation of a preanalytical quality monitoring system based on observation of evidence-based QIs and patient-centered evaluation of errors through risk analysis with regular tailored education as well as implementing process improvements can effectively reduce preanalytical errors in the emergency laboratory and improve patient safety.

journal_name

Clin Chem Lab Med

authors

Flegar-Meštrić Z,Perkov S,Radeljak A,Kardum Paro MM,Prkačin I,Devčić-Jeras A

doi

10.1515/cclm-2016-0235

subject

Has Abstract

pub_date

2017-03-01 00:00:00

pages

368-377

issue

3

eissn

1434-6621

issn

1437-4331

pii

/j/cclm.ahead-of-print/cclm-2016-0235/cclm-2016-02

journal_volume

55

pub_type

杂志文章
  • Development and multicenter performance evaluation of fully automated SARS-CoV-2 IgM and IgG immunoassays.

    abstract:Objectives:The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly spread globally. The laboratory diagnosis of SARS-CoV-2 infection has relied on nucleic acid testing; however, it has some limitations, such as low throughput and high rates of false negatives. Tests of higher sensitivit...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,多中心研究

    doi:10.1515/cclm-2020-0548

    authors: Qian C,Zhou M,Cheng F,Lin X,Gong Y,Xie X,Li P,Li Z,Zhang P,Liu Z,Hu F,Wang Y,Li Q,Zhu Y,Duan G,Xing Y,Song H,Xu W,Liu BF,Xia F

    更新日期:2020-07-15 00:00:00

  • Investigation of the relationship between apolipoprotein E gene polymorphisms and hepatitis B virus infection in northern China.

    abstract:BACKGROUND:Certain genetic polymorphisms can lead to differences in immunity function, resulting in different clinical outcomes for hepatitis B virus (HBV) patients. The aim of this study was to investigate the association between apolipoprotein E (ApoE) gene polymorphisms and HBV infection status in northern Chinese i...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2010.354

    authors: Yin Z,Xiong C,Wang Y,Zhou X,Yan SK

    更新日期:2010-12-01 00:00:00

  • The D allele of angiotensin I-converting enzyme gene insertion/deletion polymorphism is associated with the severity of atherosclerosis.

    abstract:BACKGROUND:Angiotensin II is produced primarily by angiotensin I-converting enzyme (ACE) within atherosclerotic lesions and ACE level in plaques correlates with the severity of vessel wall damage. Therefore, we investigated the possible association of ACE gene insertion/deletion (I/D) polymorphism and the severity of a...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2008.101

    authors: Niemiec P,Zak I,Wita K

    更新日期:2008-01-01 00:00:00

  • Study of apo(a) length polymorphism and lipoprotein(a) concentrations in subjects with single or double apo(a) isoforms.

    abstract::Cardiovascular risk is associated with high lipoprotein(a) (Lp(a)) concentrations and low molecular weight apolipoprotein(a) (apo(a)) isoforms. We studied the relationship between these two biological parameters, particularly in subjects expressing two apo(a) isoforms. Plasma Lp(a) was measured by immunonephelometry i...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2003.096

    authors: Alaoui M,Merle C,Garnotel R,Jolly D,Durlach V,Gillery P

    更新日期:2003-05-01 00:00:00

  • Automated cell disruption is a reliable and effective method of isolating RNA from fresh snap-frozen normal and malignant oral mucosa samples.

    abstract:BACKGROUND:This study compared automated vs. manual tissue grinding in terms of RNA yield obtained from oral mucosa biopsies. METHODS:A total of 20 patients undergoing uvulectomy for sleep-related disorders and 10 patients undergoing biopsy for head and neck squamous cell carcinoma were enrolled in the study. Samples ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm.2009.070

    authors: Van der Vorst S,Dekairelle AF,Irenge L,Hamoir M,Robert A,Gala JL

    更新日期:2009-01-01 00:00:00

  • Determination of the fatty acid profile of neutral lipids, free fatty acids and phospholipids in human plasma.

    abstract:BACKGROUND:Knowledge of the fatty acid composition of lipid classes in human plasma is an important factor in the investigation of human metabolism. Therefore, a method for the analysis of neutral lipid (NL), phospholipid (PL) and free fatty acids (FFA) in human plasma has been developed and validated. METHODS:Separat...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2012-0203

    authors: Firl N,Kienberger H,Hauser T,Rychlik M

    更新日期:2013-04-01 00:00:00

  • Opinion paper on utility of point-of-care biomarkers in the emergency department pathways decision making.

    abstract::Overcrowding of the emergency department (ED) is rapidly becoming a global challenge and a major source of concern for emergency physicians. The evaluation of cardiac biomarkers is critical for confirming diagnoses and expediting treatment decisions to reduce overcrowding, however, physicians currently face the dilemm...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2014-0267

    authors: Di Somma S,Zampini G,Vetrone F,Soto-Ruiz KM,Magrini L,Cardelli P,Ronco C,Maisel A,Peacock FW

    更新日期:2014-10-01 00:00:00

  • Development of a new biochip array for APOE4 classification from plasma samples using immunoassay-based methods.

    abstract:BACKGROUND:Apolipoprotein E (APOE) is a key player in lipid transport and metabolism and exists in three common isoforms: APOE2, APOE3 and APOE4. The presence of the E4 allelic variant is recognized as a major genetic risk factor for dementia and other chronic (neuro)degenerative diseases. The availability of a validat...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2017-0618

    authors: Badrnya S,Doherty T,Richardson C,McConnell RI,Lamont JV,Veitinger M,FitzGerald SP,Zellner M,Umlauf E

    更新日期:2018-04-25 00:00:00

  • Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: I. Analyte definition and proposal of a candidate reference method.

    abstract::An alcohol-associated change in the serum transferrin glycoform pattern, carbohydrate-deficient transferrin (CDT), is used as a biomarker of chronic moderate to heavy alcohol consumption. A current limitation in CDT analysis is the lack of standardization, which hampers clinical and analytical comparison between studi...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2007.107

    authors: Jeppsson JO,Arndt T,Schellenberg F,Wielders JP,Anton RF,Whitfield JB,Helander A,International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Standardization of Carbohydrate-deficient Transferin (IFCC-WG-CDT).

    更新日期:2007-01-01 00:00:00

  • Evaluation of a novel extended automated particle-based multi-analyte assay for the detection of autoantibodies in the diagnosis of primary biliary cholangitis.

    abstract:Background:Anti-mitochondrial autoantibodies (AMA) detected by indirect immunofluorescence (IIF) on rodent tissues are the diagnostic marker of primary biliary cholangitis (PBC). However, up to 15% of patients with PBC are AMA-negative by IIF. In the effort to close the serological gap and improve the diagnostic sensit...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2020-0122

    authors: Villalta D,Seaman A,Tiongson M,Warren C,Bentow C,Bizzaro N,Alessio MG,Porcelli B,Norman GL,Mahler M

    更新日期:2020-04-10 00:00:00

  • Reference change values for lens culinaris agglutinin-reactive α-fetoprotein and des-γ-carboxy prothrombin in patients with chronic hepatitis C.

    abstract:BACKGROUND:Lens culinaris agglutinin-reactive α-fetoprotein (AFP-L3) and des-γ-carboxy prothrombin (DCP) have been routinely used as serological tumor markers of hepatocellular carcinoma (HCC) for surveillance. The aims of this study were: (i) to determine the biological variation of AFP-L3 and DCP in patients with chr...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2011-0912

    authors: Kanke F,Kumada T,Toyoda H,Satomura S

    更新日期:2012-03-06 00:00:00

  • Novel haptoglobin insertion/deletion polymorphism is associated with the lipid profile and C-reactive protein (CRP) concentration.

    abstract::We discovered a hitherto undescribed insertion/deletion (I/D) polymorphism of 7 base pairs in intron 4 of the HP1 allele and intron 4 and 6 of the HP2 allele. Genotyping was performed in 311 Belgian subjects. The association between serum haptoglobin (Hp) and lipid concentrations and the Hp I/D genotypes was investiga...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2002.081

    authors: Wuyts B,Hetet G,Grandchamp B,Delanghe JR

    更新日期:2002-05-01 00:00:00

  • Glycated albumin may be a possible alternative to hemoglobin A1c in diabetic patients with anemia.

    abstract:BACKGROUND:We assessed whether glycated albumin (GA) is a useful glycemic indicator in diabetic patients with anemia who did not undergo dialysis. METHODS:Hemoglobin A(1c) (HbA(1c)) and GA were simultaneously measured in 370 diabetic subjects who had not undergone dialysis. The relationship between GA and HbA(1c) was ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2011.646

    authors: Kim S,Min WK,Chun S,Lee W,Park HI

    更新日期:2011-10-01 00:00:00

  • Nobelitis: a common disease among Nobel laureates?

    abstract::Winning a Nobel Prize is a great personal achievement. Some Nobel laureates may consider that their award is a certificate of competence in any field. This may prompt them to undertake projects or accept positions which are beyond their capabilities. Since Nobels are awarded when the laureates have usually passed thei...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2013-0273

    authors: Diamandis EP

    更新日期:2013-08-01 00:00:00

  • Clinical relevance of circulating midkine in ulcerative colitis.

    abstract:BACKGROUND:Non-invasive biochemical markers are needed to support the diagnosis of ulcerative colitis (UC), an incurable disease of unknown pathology. Midkine is an angiogenic cytokine, chemotactic towards neutrophils and macrophages, and a T-regulatory cell suppressor. METHODS:Serum midkine was measured immunoenzymat...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2009.248

    authors: Krzystek-Korpacka M,Neubauer K,Matusiewicz M

    更新日期:2009-01-01 00:00:00

  • Biological variation and quantification of health: the emergence of the concept of normality.

    abstract::Historical research on the concept of normality, its roots and its development show that this concept has its sources in very different areas of scientific and medical thinking. Of great importance were: (i) a new theory of disease arising early in the 19th century supposing a continuous change from the healthy to the...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 历史文章,杂志文章

    doi:10.1515/CCLM.1998.013

    authors: Büttner J

    更新日期:1998-01-01 00:00:00

  • Nitration of human plasminogen by RAW 264.7 macrophages reduces streptokinase-induced plasmin activity.

    abstract::Despite many years of study, clinical trials of new drugs to prevent thrombosis have often been disappointing. Part of the problem lies in our incomplete understanding of the regulation of plasminogen activation and/or inhibition in vivo. We have previously shown that in vitro nitration of plasminogen in plasma by per...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2006.039

    authors: Hathuc C,Hermo R,Schulze J,Gugliucci A

    更新日期:2006-01-01 00:00:00

  • Influence of pancreatic status on circulating plasma sterols in patients with cystic fibrosis.

    abstract::Background Patients with cystic fibrosis (CF) have a reduced intestinal absorption of cholesterol and in a preliminary study we observed differences in plasma sterol profile between patients with pancreatic sufficiency (PS) and those with pancreatic insufficiency (PI). Therefore, we hypothesized that the sterol analys...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2019-1112

    authors: Gelzo M,Iacotucci P,Sica C,Liguori R,Comegna M,Carnovale V,Dello Russo A,Corso G,Castaldo G

    更新日期:2020-09-25 00:00:00

  • Laboratory medicine as the science that underpins medicine: the "high-sensitivity" troponin paradigm.

    abstract::The availability of so-called high-sensitivity troponin assays (hsTn) has scored a compelling goal for laboratory medicine, allowing the safe clinical application of international recommendations for the definition of acute myocardial infarction (AMI). However, the introduction of hsTn has not been welcomed by clinici...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章,评审

    doi:10.1515/cclm-2014-0812

    authors: Ferraro S,Panteghini M

    更新日期:2015-04-01 00:00:00

  • An automated assay of urinary alanine aminopeptidase activity.

    abstract:BACKGROUND:Urinary enzymes, including the brush border enzyme alanine aminopeptidase (AAP), are reliable biomarkers of nephrotoxicity and represent early indicators of tubular damage. The aim of the present study was to develop and validate an automated urinary AAP activity assay. METHODS AND RESULTS:For this purpose,...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2008.103

    authors: Holdt B,Peters E,Nagel HR,Steiner M

    更新日期:2008-01-01 00:00:00

  • Age- and gender-specific reference ranges for serum insulin-like growth factor I (IGF-I) and IGF-binding protein-3 concentrations on the Immulite 2500: results of the Study of Health in Pomerania (SHIP).

    abstract:BACKGROUND:The objective of the present study was to calculate age- and gender-specific reference ranges for serum insulin-like growth factor I (IGF-I) and insulin-like growth factor binding protein 3 (IGFBP-3) concentrations using quantile regression. METHODS:From the Study of Health in Pomerania (SHIP), 1798 men and...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2010.009

    authors: Friedrich N,Krebs A,Nauck M,Wallaschofski H

    更新日期:2010-01-01 00:00:00

  • Investigation on the ability of first trimester glycodelin and angiopoietin-2 to predict small-for-gestational age pregnancies at delivery.

    abstract:BACKGROUND:The aim was to investigate whether first trimester glycodelin and angiopoietin-2 can predict small-for-gestational age (SGA) at delivery, individually or in combination. METHODS:In this case-control study we measured glycodelin and angiopoietin-2 on serum from 170 singleton pregnant women delivering SGA neo...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2015-0989

    authors: Hansen YB,Myrhøj V,Jørgensen FS,Sørensen S

    更新日期:2016-09-01 00:00:00

  • Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: II. Performance of a laboratory network running the HPLC candidate reference measurement procedure and evaluation of a candidate reference material.

    abstract::Carbohydrate-deficient transferrin (CDT) is a descriptive term used for a temporary change in the transferrin glycosylation profile caused by alcohol, and used as a biomarker of chronic high alcohol consumption. The use of an array of methods for measurement of CDT in various absolute or relative amounts, and sometime...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2010.322

    authors: Helander A,Wielders JP,Jeppsson JO,Weykamp C,Siebelder C,Anton RF,Schellenberg F,Whitfield JB,IFCC Working Group on Standardization of Carbohydrate-Deficient Transferrin (WG-CDT).

    更新日期:2010-11-01 00:00:00

  • Haemoglobin A1c: analysis and standardisation.

    abstract::The measurement of glycated haemoglobin has become centrally important in the monitoring of glycaemic control in the patient with diabetes. A number of analytical techniques have been described to measure this important haemoglobin fraction, and the fraction measured depends on the technique used; this has resulted in...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 历史文章,杂志文章

    doi:10.1515/CCLM.2003.184

    authors: John WG

    更新日期:2003-09-01 00:00:00

  • Comparison of standard PCR and the LightCycler technique to determine the thrombophilic mutations: an efficiency and cost study.

    abstract::For several years it has been possible to routinely detect numerous mutations in the human genome by different methods. The most common technique is a standard PCR, but real time fluorescence PCR is increasingly being used. The purpose of this paper is to compare these two different techniques from the point of view o...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2003.072

    authors: Schroell-Metzger B,Dicato M,Bosseler M,Berchem G

    更新日期:2003-04-01 00:00:00

  • Androgen deprivation decreases prostate specific antigen in the absence of tumor: implications for interpretation of PSA results.

    abstract:BACKGROUND:Prostate-specific antigen (PSA) is used as an outcome measure for relapsed disease in prostate cancer. Nonetheless, there are considerable concerns about its indiscriminate use as a surrogate endpoint for cell growth or survival. We hypothesized that treatment with a luteinizing hormone releasing hormone (LH...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2013-0535

    authors: Wenisch JM,Mayr FB,Spiel AO,Radicioni M,Jilma B,Jilma-Stohlawetz P

    更新日期:2014-03-01 00:00:00

  • Anemia and iron biomarkers in patients with early breast cancer. Diagnostic value of hepcidin and soluble transferrin receptor quantification.

    abstract:BACKGROUND:Anemia, a frequent and deleterious condition in patients with cancer, is mainly caused by chemotherapy toxicity, iron deficiency, or inflammation. We evaluated the baseline iron metabolism biomarkers and their association with anemia occurrence during chemotherapy in patients with early breast cancer (EBC). ...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2013-0031

    authors: Durigova A,Lamy PJ,Thezenas S,Pouderoux S,Montels F,Romieu G,Gutowski M,Jacot W

    更新日期:2013-09-01 00:00:00

  • Assessment of the clinical utility of adding common single nucleotide polymorphism genetic scores to classical risk factor algorithms in coronary heart disease risk prediction in UK men.

    abstract:BACKGROUND:Risk prediction algorithms for coronary heart disease (CHD) are recommended for clinical use. However, their predictive ability remains modest and the inclusion of genetic risk may improve their performance. METHODS:QRISK2 was used to assess CHD risk using conventional risk factors (CRFs). The performance o...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/cclm-2016-0984

    authors: Beaney KE,Cooper JA,Drenos F,Humphries SE

    更新日期:2017-08-28 00:00:00

  • Characteristics of prolidase from the erythrocytes of normal humans and patients with prolidase deficiency and their mother.

    abstract::Prolidases I and II were highly purified from human erythrocytes. The effects of various amino acids, MnCl2 and mercaptoethanol, on these two enzymes were investigated. Normal prolidase II was very labile in the absence of MnCl2 or mercaptoethanol. The activity of prolidase II was maintained at about 76% by pre-incuba...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.2003.202

    authors: Nakayama K,Awata S,Zhang J,Kaba H,Manabe M,Kodama H

    更新日期:2003-10-01 00:00:00

  • Influence of time and temperature on coagulation analytes in stored plasma.

    abstract::There is no comprehensive study on the stability of coagulation analytes in plasma. We therefore determined the influence of storage time and temperature on prothrombin time, activated partial thromboplastin time, thrombin time, fibrinogen, factors V and VIII, antithrombin III, protein C and S in plasma from 20 health...

    journal_title:Clinical chemistry and laboratory medicine

    pub_type: 杂志文章

    doi:10.1515/CCLM.1998.077

    authors: Heil W,Grunewald R,Amend M,Heins M

    更新日期:1998-06-01 00:00:00