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

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).

Standardization in laboratory medicine: Adoption of common reference intervals to the Croatian population.

Considering the fact that the results of laboratory tests provide useful information about the state of health of patients, determination of reference value is considered an intrinsic part in the development of laboratory medicine. There are still huge differences in the analytical methods used as well as in the associated reference intervals which could consequently significantly affect the proper assessment of patient health. In a constant effort to increase the quality of patients' care, there are numerous international initiatives for standardization and/or harmonization of laboratory diagnostics in order to achieve maximum comparability of laboratory test results and improve patient safety.

Heat shock protein 70 and antibodies to heat shock protein 60 are associated with cerebrovascular atherosclerosis.

Objectives: Heat shock proteins (Hsps) are produced by all cells, including vascular, to ensure stress protection. Damaged cells release Hsps in their local environment and systemic circulation. The aim of this study was to investigate the involvement and prognostic utility of serum Hsp60 and Hsp70, and the respective antibodies anti-Hsp60 and anti-Hsp70 in subjects with advanced atherosclerosis resulting in high degree of cerebrovascular stenosis.

Comparison of approaches and measurement of continuing professional development for specialists in laboratory medicine within four European countries.

Background: This study investigated approaches to continuing professional development (CPD) for specialists in laboratory medicine within four European countries: Croatia, the Czech Republic, Malta and the UK.

Methods: The research questions focussed on ascertaining if continued registration/licence was linked to CPD and if so, were there requirements for certain amounts and types of CPD and for CPD activities to meet specified accreditation criteria. The Professional Associations Research Network (PARN) model of CPD measurement was applied to each country's registration/licencing body's CPD requirements.

Paraoxonase 1 activity and phenotype distribution in premenopausal and postmenopausal women.

Introduction: Postmenopausal women have higher risk of cardiovascular disease. One of the contributing factors could be reduced activity of anti-atherogenic enzyme paraoxonase 1 (PON1). The aim of this study was to examine differences in the lipid status, paraoxonase and arylesterase PON1 activities and PON1 phenotype in women with regular menstrual cycle and in postmenopausal women.

Importance of urinary NGAL, serum creatinine standardization and estimated glomerular filtration rate in resistant hypertension.

In patients with resistant hypertension (RH) we investigated the importance of urinary neutrophil gelatinase-associated lipocalin (uNGAL- a chemiluminescent microparticle immunoassay (CMIA) method became using (Abbott Diagnostics) for the measurement of NGAL in urine samples) and incidence of chronic kidney disease using the Modification of Diet in Renal Disease Study (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations in estimating glomerular filtration rate (eGFR) based on standardised serum creatinine method traceable to isotope dilution mass spectrometry (IDMS) method. It would have been difficult to predict that levels of these biomarker would perform better organ damage than traditional measurements of kidney function such as standardised serum creatinine, MDRD, or CKD-EPI equations in special population such as RH. Serum creatinine concentrations were measured in 50 patients (24M:26F from RH Registar in Clinical Hospital Merkur) by the kinetic Jaffe method.

Differences in routine laboratory parameters related to cachexia between patients with hematological diseases and patients with solid tumors or heart failure - is there only one cachexia?

Background: Cachexia is a state of involuntary weight loss common to many chronic diseases. Experimental data, showing that cachexia is related to the enhancement of acute phase response reaction, led to the new definition of cachexia that included, aside from the principal criterion of weight loss, other "minor criteria", Amongst them are levels of C-reactive protein (CRP), albumin and hemoglobin. However, there is paucity of data regarding possible differences of these laboratory parameters in patients with various diseases known to be related to cachexia.

Trace elements and oxidative stress in hypertensive disorders of pregnancy.

Purpose: Due to increased metabolic requests, pregnancy can be considered as metabolic stress, especially if associated with oxidative stress triggered by disbalance of pro/antioxidants. The aim of the study was to determine serum concentrations of the trace elements iron (Fe), zinc (Zn) and copper (Cu) important in growth regulation and pro/anti-oxidant homeostasis, in relation to the total serum oxidant capacity (TOC) and total serum antioxidant capacity (TAC) in pregnant women with preeclampsia (n = 30) or with gestational hypertension (n = 30) and in healthy pregnant women (n = 37) and non-pregnant women (n = 30) as control groups expecting common differences between all pregnant women and controls and between preeclampsia and the other pregnancies indicating specific disbalance of the oxidative stress and analyzed trace elements.

Methods: Serum Fe was determined by spectrophotometric method, Cu and Zn were determined by atomic absorption spectrometry, TOC was determined by Enzymatic ANTIOX-CAP assay and TAC by Peroxide-activity assay.

Proteomics of inflammatory and oxidative stress response in cows with subclinical and clinical mastitis.

Cow serum proteome was evaluated by three different complementary approaches in the control group, subclinical and clinical mastitis in order to possibly find differential protein expression useful for a better understanding of the pathophysiology of mastitis as well as for an early diagnosis of the disease. The systemic inflammatory and oxidative stress response in cows with subclinical and clinical mastitis were observed. The collected evidence shows a differential protein expression of serpin A3-1, vitronectin-like protein and complement factor H in subclinical mastitis in comparison with the control.

Validation of a laboratory and hospital information system in a medical laboratory accredited according to ISO 15189.

Introduction: The aim of the study was to present a protocol for laboratory information system (LIS) and hospital information system (HIS) validation at the Institute of Clinical Chemistry and Laboratory Medicine of the Merkur University Hospital, Zagreb, Croatia.

Materials And Methods: Validity of data traceability was checked by entering all test requests for virtual patient into HIS/LIS and printing corresponding barcoded labels that provided laboratory analyzers with the information on requested tests. The original printouts of the test results from laboratory analyzer(s) were compared with the data obtained from LIS and entered into the provided template.

[Significance of participation in programs of external quality assessment in molecular diagnostic--our experience].

Harmonization of molecular diagnostic tests in laboratories in the Republic of Croatia has only just started. According to laboratory accreditation standard ISO 15189 participation in external quality assessment (EQA) schemes or programs is a prerequisite and support tool for clinical laboratory accreditation process. As there are no national quality assurance schemes yet, an European external quality assessment (EQA) scheme or program should be found.

[Flow cytometry and acute renal rejection confirmed by histopathologic analysis].

Transplantation of solid organs, tissues or hematopoietic cells is now standard in the treatment of patients with terminal stage disease in order to cure and improve the recipients' quality of life. The study included 54 patients having undergone single or multiple organ transplantation. All patients received a combination of immunosuppressant therapy consisting of corticosteroids, calcineurin inhibitor (cyclosporine; tacrolimus), anti-CD25 (daclizumab) and mycophenolate-mofetil.

[Standardization in laboratory hematology by participating in external quality assurance programs].

Since 1985, Department of Clinical Chemistry and Laboratory Medicine, Merkur University Hospital, Zagreb, has been participating in the International External Quality Assessment Scheme for Hematology (IEQAS-H) organized by the World Health Organization (WHO). Owing to very good results, in 1987 the Department received a certificate of participation in this control scheme. Department has been cooperating in the external quality assessment program in laboratory hematology which has been continuously performed in Croatia since 1986 by the Committee for External Quality Assessment Schemes under the auspices of the Croatian Society of Medical Biochemists and School of Pharmacy and Biochemistry, University of Zagreb.

[The purpose of clinical laboratory accreditation in transplantation medicine].

Although transplantation of solid organs has become a more standardized method of treatment, liver transplantation represents an exceptional multidisciplinary clinical procedure requiring understanding of specific pathophysiological changes that occur in the end stage of liver disease. Liver transplantation has been performed at Merkur University Hospital since 1998, with 360 transplantations performed to date. The most common indications are alcohol liver disease, cirrhosis caused by hepatitis B and C virus, hepatocellular carcinoma and cryptogenetic liver cirrhosis.

Polymorphisms of pon1 and pon2 genes in hemodialyzed patients.

Objectives: Q192R, L55M and -108C>T polymorphisms of pon1 gene affect PON1 paraoxonase activity while S311C polymorphism of pon2 gene might be associated with coronary heart disease. The aims of this study were to determine the frequencies of Q192R, L55M, -108C>T and S311C polymorphisms in hemodialyzed patients and to examine the relationship between pon1 gene polymorphisms and PON1 paraoxonase activity in those patients.

Design And Methods: The study included 238 control subjects and 263 hemodialyzed patients.

Serum platelet-activating factor acetylhydrolase and paraoxonase-1 activity in horses infected with Leptospira spp.

The aim of the study was to investigate the effect of infection with Leptospira spp. in horses on activities of platelet-activating factor acetylhydrolase (PAF-AH) and paraoxonase-1 (PON1) considering the anti-inflammatory/anti-oxidative properties of both enzymes. A total of 63 sport and leisure horses' sera were chosen among those routinely serologically examined on leptospirosis during the year 2009 in Croatia.

Effect of non-genetic factors on paraoxonase 1 activity in patients undergoing hemodialysis.

Objectives: Hemodialyzed patients have lower paraoxonase 1 (PON1) activity. Higher mortality risk from cardiovascular disease observed in these patients could be due to the low antiathetrogenic activity of PON1. Understanding the mechanism that causes lower PON1 activity could provide the possibility for modulation of enzyme activity in purpose of preventing and/or decreasing development of atherosclerosis.

Flow cytometry immunophenotyping (FCI) of fine needle aspirates (FNAs) of lymph nodes.

Flow cytometry immunophenotyping (FCI) has an important role in the clinic work-up of fine needle aspirates (FNAs) of lymph nodes. Its standardization has been defined by proposed analytical protocols and procedures used to assure proper analytical results also in those non-routine samples. In Institute of Clinical Chemistry, "Merkur" University Hospital, FCI is accredited method according to laboratory accreditation standard ISO 15189.

Accreditation of medical laboratories in Croatia--experiences of the Institute of Clinical Chemistry, University Hospital "Merkur", Zagreb.

Since 2003 when the international norm for implementation of quality management in medical laboratories (EN ISO 15189, Medical laboratories--Particular requirements for quality and competence) was established and accepted, accreditation has become practical, generally accepted method of quality management and confirmation of technical competence of medical laboratories in the whole world. This norm has been translated into Croatian and accepted by the Croatian Institute for Norms as Croatian norm. Accreditation is carried out on voluntary basis by the Croatian Accreditation Agency that has up to now accredited two clinical medical biochemical laboratories in the Republic of Croatia.

External quality assessment in clinical cell analysis by flow cytometry. Why is it so important?

Participation in external quality assessment is an integral part of laboratory work and mandatory when the results have a clinical application, which is one of the requirements of standard 15189 for accreditation of medical laboratories. Institute of Clinical Chemistry, the first laboratory accredited for clinical cell analysis by flow cytometry in Croatia, participated in UKNEQAS for Leukocyte Immunophenotyping in 3 schemes: "Immune Monitoring", "CD34 Stem Cell Enumeration" and "Leukaemia Immunophenotyping". For sample processing on EPICS XL flow cytometer, lyse/no wash preparation technique with ammonium chloride (NH4Cl) or ImmunoPrep lysing reagent was employed.

Applicability of common reference intervals for serum creatinine concentrations to the Croatian population.

Background: In accordance with an ongoing activity for worldwide harmonization based on traceability in laboratory methods, the goal of this study was to validate the applicability of recommended "common" reference intervals for serum creatinine concentrations using a specific enzymatic method to the Croatian population.

Methods: The reference group consisted of 240 healthy subjects (120 males and 120 females), between 18 and 74 years of age (median 57 years), who were selected in accordance with the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommendations. Creatinine in serum was measured using the creatinine enzymatic assay (Olympus OSR61204) that was standardized to the isotopic dilution mass spectrometry (IDMS) method and National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 967.

Effect of splenectomy and autologous spleen transplantation on the serum platelet-activating factor acetylhydrolase (PAF-AH) activity and acute phase response (APR) in a porcine model.

The aim of this study was to evaluate the inflammatory response after total splenectomy and spleen autotransplantation in a porcine model by measuring serum platelet-activating factor acetylhydrolase activity, C-reactive protein and albumin concentrations. Nineteen piglets were used in the experiment. After induction of anesthesia, animals were randomly divided into three groups: sham-operation with spleens intact (n = 6), total splenectomy (n = 6), and splenic autotransplantation (n = 7) with small fragments of the spleen autotransplanted into the greater omentum.

Stenotic occlusive lesions of internal carotid artery in diabetic patients.

Diabetes deteriorates atherosclerotic changes in the arteries. The aim of the study was to assess the prevalence and localization of stenotic atherosclerotic lesions of the internal carotid artery (ICA) in patients with diabetes. A prospective analysis of angiography findings was carried out in 150 diabetic and 150 non-diabetic patients with symptoms of cerebral ischemia using double-blind angiogram readings by two independent investigators.

Atherosclerotic lesions of supra-aortic arteries in diabetic patients.

The aim of this prospective study was to determine the prevalence and localization of stenotic atherosclerotic lesions of supra-aortic arteries in diabetic patients according to age and sex. Angiograms obtained by digital subtraction angiography were analyzed in 150 diabetic patients (study group) and 150 non-diabetic patients (control group) with symptoms of cerebral ischemia. Diabetic patients were found to have a significantly higher prevalence of stenotic atherosclerotic lesions of the internal carotid artery.

Bovine platelet-activating factor acetylhydrolase (PAF-AH) activity related to fertility.

Plasma platelet-activating factor acetylhydrolase (PAF-AH), the enzyme characterized by the association with plasma lipoproteins, degrades platelet-activating factor (PAF) as well as PAF-like oxidatively fragmented phospholipids produced during oxidative stress. Apart from pro-inflammatory properties, PAF is also related to reproductive processes and successful fertility. In order to get a better insight into the involvement of PAF-AH in the fertility of cows, the aim of the study was to determine the PAF-AH activity as well as the C-reactive protein, cholesterol and high density lipoprotein-cholesterol (HDL-C) in the serum of dairy cows throughout the pregnancy and lactation, as well as in infertile cows.