Abstract:
AIM:Medical laboratories are the key partners in patient safety. Laboratory results influence 70% of medical diagnoses. Quality of laboratory service is the major factor which directly affects the quality of health care. The clinical laboratory as a whole has to provide the best patient care promoting excellence. METHODS:International Standard ISO 15189, based upon ISO 17025 and ISO 9001 standards, provides requirements for competence and quality of medical laboratories. Accredited medical laboratories enhance credibility and competency of their testing services. Our group of laboratories, one of the leading institutions in the area, had previous experience with ISO 9001 and ISO 17025 Accreditation at non-medical sections. We started to prepared for ISO 15189 Accreditation at the beginning of 2006 and were certified in March, 2007. We spent more than a year to prepare for accreditation. RESULTS:Accreditation scopes of our laboratory were as follows: clinical chemistry, hematology, immunology, allergology, microbiology, parasitology, molecular biology of infection serology and transfusion medicine. The total number of accredited tests is 531. We participate in five different PT programs. Inter Laboratory Comparison (ILC) protocols are performed with reputable laboratories. 82 different PT Program modules, 277 cycles per year for 451 tests and 72 ILC program organizations for remaining tests have been performed. Our laboratory also organizes a PT program for flow cytometry. 22 laboratories participate in this program, 2 cycles per year. Our laboratory has had its own custom made WEB based LIS system since 2001. We serve more than 500 customers on a real time basis. Our quality management system is also documented and processed electronically, Document Management System (DMS), via our intranet. CONCLUSION:Preparatory phase for accreditation, data management, external quality control programs, personnel related issues before, during and after accreditation process are presented. Every laboratory has to concentrate on patient safety issues related to laboratory testing and should perform quality improvement projects.
journal_name
Clin Biochemjournal_title
Clinical biochemistryauthors
Guzel O,Guner EIdoi
10.1016/j.clinbiochem.2008.09.011subject
Has Abstractpub_date
2009-03-01 00:00:00pages
274-8issue
4-5eissn
0009-9120issn
1873-2933pii
S0009-9120(08)00399-8journal_volume
42pub_type
杂志文章abstract:OBJECTIVES:To verify the role of IL-12 in the pathogenesis of psoriasis and determine its relation to IFNgamma. DESIGN AND METHODS:Skin biopsies from lesional and non-lesional skin of 30 patients and 10 healthy controls were obtained for quantitative PCR examination of IL-12 (P40) and IFNgamma mRNA as well as in situ ...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2005.11.008
更新日期:2006-02-01 00:00:00
abstract:OBJECTIVE:To externally validate a clinical decision rule incorporating heart fatty acid binding protein (h-FABP), high-sensitivity troponin (hs-cTn) and electrocardiogram (ECG) for the detection of acute myocardial infarction (AMI) on presentation to the Emergency Department. We also investigated whether this clinical...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2017.10.001
更新日期:2018-02-01 00:00:00
abstract:OBJECTIVES:End-stage renal disease (ESRD) is characterized by profound dyslipidemia and enhanced oxidative stress. The patients also show evidence of exhausted and/or deficient anti-oxidative defense enzymes, one of them being glutathione-S-transferase (GST). This study investigates relationship between GST gene polymo...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2013.11.011
更新日期:2014-04-01 00:00:00
abstract:OBJECTIVES:To assess the medical applicability of CpG methylation as molecular markers for cancer diagnosis, we established a new system to determine DNA methylation based on TaqMan PCR combined with a methyl-binding-domain polypeptide 2. DESIGN AND METHODS:We evaluated the diagnostic applicability of this approach by...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2009.03.017
更新日期:2009-07-01 00:00:00
abstract::Our studies lead us to suggest that in order for an organic chemical to cause porphyrin accumulation in chick embryo hepatocyte culture, it must be: 1. lipophilic; 2. resistant to biotransformation by phase I or phase II reactions to compounds which are devoid of biological activity; and 3. capable of interacting with...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(89)80073-6
更新日期:1989-06-01 00:00:00
abstract::Three commercially available assays (an enzyme-linked immunosorbent assay ELISA, an immunoradiometric assay, IRMA, and a nephelometric assay) for the determination of lipoprotein(a) [Lp(a)] were compared with respect to the dependency of these assays on the various apolipoprotein(a) [apo(a)] isoforms. Although there w...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/0009-9120(94)00052-w
更新日期:1994-12-01 00:00:00
abstract:OBJECTIVES:We determined the frequencies of apolipoprotein E (apo E) gene alleles and examined the association between apo E polymorphism and lipid parameters in a sample of the Tunisian population. DESIGN AND METHODS:Apo E polymorphism was investigated using PCR, and plasma lipid parameters were measured in 122 men a...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2006.04.018
更新日期:2006-08-01 00:00:00
abstract::A procedure for the assay of glucose-6-phosphate dehydrogenase (EC 1.1.1.49) in erythrocytes on the GEMSAEC centrifugal analyzer using a modification of Beutler's procedure is described. Glucose-6-phosphate dehydrogenase activity is corrected for the contributing activity of 6-phosphogluconate dehydrogenase (EC 1.1.1....
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(79)80085-5
更新日期:1979-10-01 00:00:00
abstract:BACKGROUND:Niemann-Pick type C (NP-C) is a rare progressive neurodegenerative lipid storage disorder with heterogeneous clinical presentation and challenging diagnostic procedures. Recently oxysterols have been reported to be specific biomarkers for NP-C but knowledge on the intra-individual variation and on reference ...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2015.03.007
更新日期:2015-06-01 00:00:00
abstract:OBJECTIVE:Mycophenolic acid requires routine therapeutic drug monitoring. We evaluated the suitability of a new PETINIA (particle enhanced turbidimetric inhibition immunoassay) assay on the Dimension EXL analyzer for monitoring of mycophenolic acid by comparing values obtained by this assay with a HPLC-UV method. DESI...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2012.11.025
更新日期:2013-05-01 00:00:00
abstract:OBJECTIVES:Non-invasive prenatal aneuploidy testing (NIPT) by next-generation sequencing of circulating cell-free DNA in maternal plasma relies on chromosomal ratio (chrratio) measurements to detect aneuploid values that depart from euploid ratios. Diagnostic performances are known to depend on the fraction of fetal DN...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2018.06.015
更新日期:2018-09-01 00:00:00
abstract:OBJECTIVE:To develop a Rapid Flow-through assay for distinguishing replicating Tiantan vaccine-generated serological response from true HIV infection. DESIGN AND METHOD:A Rapid Flow-through Test including gp41, gp36, sk1, sk2 and sk3 antigens was established and the performance of the assay was evaluated in clinical s...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2012.05.013
更新日期:2012-10-01 00:00:00
abstract::With increasing patient volumes and growing demands for rapid turnaround on many clinical tests, there is a demand for high-throughput technologies. High-Throughput Online Solid-Phase Extraction Tandem Mass Spectrometry is an example of one technology that can achieve these desired results and the RapidFire 365 Mass S...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2016.04.012
更新日期:2016-09-01 00:00:00
abstract:INTRODUCTION:In the Olympus uric acid procedure, uric acid is converted by uricase to allantoin and hydrogen peroxide, which is reacted in a Trinder reaction to produce a chromophore read bichromatically at 520 and 660 nm. Repeated difficulty was encountered in obtaining uric acid results on samples from myeloma patien...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(98)00064-2
更新日期:1998-10-01 00:00:00
abstract:OBJECTIVES:Matrix-assisted laser desorption time-of flight ionization (MALDI)-imaging MS (IMS) with MSMS analysis using on-tissue tryptic digests is a powerful tool for identification of disease-related proteins in formalin-fixed paraffin-embedded (FFPE) tissue sections. We applied this novel IMS technique, not only to...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2013.05.063
更新日期:2013-10-01 00:00:00
abstract::The Institute of Medicine (IOM) report (1999) stated that the prevalence of medical errors is high in today's health care system. Some specialties in health care are more risky than others. A varying blunder/error rate of 0.1-9.3% in clinical diagnostic laboratories has been reported in the literature. Many of these e...
journal_title:Clinical biochemistry
pub_type: 杂志文章,评审
doi:10.1016/j.clinbiochem.2004.08.009
更新日期:2004-12-01 00:00:00
abstract:OBJECTIVES:CA 15-3 and CEA are considered useful tumor markers in monitoring breast cancer patients. This study was undertaken to specifically evaluate the transient elevations in these markers that are observed during systemic treatment for metastatic disease. This phenomenon has been termed "spiking." DESIGN AND MAT...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(96)00133-6
更新日期:1997-02-01 00:00:00
abstract::1. A CK(BB) fraction was observed in sera of a patient with prostatic carcinoma. The fraction accounted for 59% of the total enzyme activity. A metastatic tumor of a prostatic carcinoma was observed to contain solely the CK(BB) isozyme. An embryonal testicular carcinoma was observed to have a higher percentage of the ...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(78)90641-0
更新日期:1978-04-01 00:00:00
abstract::We have evaluated the precision of the Ektachem 400 thin film enzymic creatinine method and compared it to that obtained for an AutoAnalyzer II (AAII) picric acid procedure. The results of the study show that the Ektachem method yields imprecise creatinine values over the low concentration range (40-240 mumol/L). Run-...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(85)80072-2
更新日期:1985-12-01 00:00:00
abstract:OBJECTIVES:Hypertension (HT) is a complex disorder influenced by both genetic and environmental factors. Recent genome-wide association studies have identified a major risk locus for atherosclerosis on chromosome 9p21.3. SNPs within the coding sequences of CDKN2A/B and the long non-coding RNA CDKN2B-AS1 could potential...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2016.02.012
更新日期:2016-07-01 00:00:00
abstract:OBJECTIVE:To clarify the possibility that midband Lp in LDL fractions might act as an atherogenic lipoprotein in their interaction with macrophages. DESIGN AND METHODS:Low density lipoproteins (LDL) isolated by zonal ultracentrifugation from midband lipoprotein-positive serum in type lib hyperlipidemics were subjected...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/0009-9120(96)00009-c
更新日期:1996-06-01 00:00:00
abstract:OBJECTIVES:We previously described a panel of four cytokines biomarkers in knee synovial fluid for acute knee pain associated with meniscal pathology. The cytokine biomarkers included interferon gamma (IFN-gamma), interleukin 6 (IL-6), monocyte chemotactic protein 1 (MCP-1), and macrophage inflammatory protein-1 beta (...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2010.04.069
更新日期:2010-07-01 00:00:00
abstract::Stenosis is a symptom of coronary artery disease (CAD), and is caused by narrowing of arteries in the heart. Over the last several decades, medical implants such as cardiac stents have been developed to counter stenosis. Upon implantation of a stent to open up a restricted artery, narrowing of the artery can reoccur (...
journal_title:Clinical biochemistry
pub_type: 杂志文章,评审
doi:10.1016/j.clinbiochem.2015.09.012
更新日期:2016-01-01 00:00:00
abstract::Improving long-term management, life-quality and outcome of transplant recipients continues to be a challenge. The impact of highly chemoattractant proteins as chemokines on transplant outcome is undeniable. These immunoactive molecules are critical in a wide variety of physiological and pathological processes, such a...
journal_title:Clinical biochemistry
pub_type: 杂志文章,评审
doi:10.1016/j.clinbiochem.2015.07.026
更新日期:2016-03-01 00:00:00
abstract:OBJECTIVES:To compare a fully automated immunoassay and a fully automated HPLC method for the quantification of HbA1c. DESIGN AND METHODS:For an inter-method comparison, 200 consecutive clinical samples were analyzed. Imprecision was studied with pooled whole blood. RESULTS:Very close agreement of results (identical ...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2008.08.084
更新日期:2008-11-01 00:00:00
abstract:OBJECTIVE:The immune-inflammatory system has been implicated in the pathogenesis of diabetic nephropathy; however, many of the mechanisms involved remain unclear. Chitotriosidase enzyme is an active human chitinase and a major protein product of activated macrophages. Although playing an important role in innate and ac...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2015.11.009
更新日期:2016-04-01 00:00:00
abstract:UNLABELLED:Experimental studies confirmed that reactive oxygen species increase endothelin-1 (ET-1) synthesis, and modulate ET-1 signaling pathway resulting in vasoconstriction and vascular remodeling. The aim of this study was to evaluate the relationship between plasma ET-1 concentration and antioxidant status in pat...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2008.11.002
更新日期:2009-03-01 00:00:00
abstract:OBJECTIVE:To confirm that the naproxen metabolite O-desmethylnaproxen interferes with the Jendrassik and Grof method for total bilirubin and was a possible cause of spurious hyperbilirubinemia in a case of naproxen overdose. DESIGN AND METHODS:Plasma was spiked with naproxen or O-desmethylnaproxen before total and dir...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2008.09.119
更新日期:2009-01-01 00:00:00
abstract:OBJECTIVES:To compare the accuracy of procalcitonin (PCT) in early-onset neonatal sepsis (EOS) using standard cut-off values and a multilevel probabilistic approach. DESIGN AND METHODS:A retrospective study of PCT was performed in 149 newborns at risk of EOS, including preterm or prolonged rupture of membranes, chorio...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/j.clinbiochem.2008.05.015
更新日期:2008-10-01 00:00:00
abstract::In hepatobiliary disease, the level of bile acids in the peripheral circulation is greatly increased due to impaired liver function. It has been suggested that serum bile acids are of greater value in confirming hepatobiliary dysfunction than the currently assayed conventional biochemical parameters. Fifty patients wi...
journal_title:Clinical biochemistry
pub_type: 杂志文章
doi:10.1016/s0009-9120(81)91052-3
更新日期:1981-12-01 00:00:00