Vesna Supak Smolcic | University of Rijeka, Faculty of Medicine (original) (raw)
Papers by Vesna Supak Smolcic
Biochemia Medica
Informed consent is a process in which a human subject who is to participate in research needs to... more Informed consent is a process in which a human subject who is to participate in research needs to give his or her consent after being properly informed of the expected benefits as well as the potential harm of the research that will be performed. The function and purpose of the research ethics committee is to ensure that the research that will take place is in accordance with the relevant ethical standards. This means that the committee must assess the appropriateness of the design of the study reviewed. Research in the field of laboratory medicine has specific features, i.e. the use of samples that remain after routine analysis, data collection from databases containing patient information, data mining, collection of laboratory management data, method/instrument comparisons and validation, etc. As most of such research is either retrospective or not directly associated with patients, the question arises as to whether all types of research require informed consent and ethics committee approval. This article aims to clarify what is specific about obtaining informed consent and ethical approval in laboratory medicine, to provide general guidance on informed consent and ethical approval requirements based on the type of study, and what information should be included in applications for ethical approval and informed consent. This could also provide some guidance for future contributors to the Biochemia Medica.
Science and engineering ethics, 2015
Instructions for authors (IFA) need to be informative and regularly updated. We hypothesized that... more Instructions for authors (IFA) need to be informative and regularly updated. We hypothesized that journals with a higher impact factor (IF) have more comprehensive IFA. The aim of the study was to examine whether IFA of journals indexed in the Journal Citation Reports 2013, "Medical Laboratory Technology" category, are written in accordance with the latest recommendations and whether the quality of instructions correlates with the journals' IF. 6 out of 31 journals indexed in "Medical Laboratory Technology" category were excluded (unsuitable or unavailable instructions). The remaining 25 journals were scored based on a set of 41 yes/no questions (score 1/0) and divided into four groups (editorial policy, research ethics, research integrity, manuscript preparation) by three authors independently (max score = 41). We tested the correlation between IF and total score and the difference between scores in separate question groups. The median total score was 26 (21...
Biochemia Medica, 2015
Introduction: Our aim was to investigate if: (a) authors of Biochemia Medica meet authorship crit... more Introduction: Our aim was to investigate if: (a) authors of Biochemia Medica meet authorship criteria given by International Committee of Medical Journal Editors (ICMJE), (b) authorship violations are more frequent in submissions containing some type of scientific misconduct. Materials and methods: Self-reported authorship contributions regarding the three ICMJE criteria were analysed for all submissions to Biochemia Medica (February 2013-April 2015) which were forwarded to peer-review. To test the differences in frequencies we used Chi-squared test. P < 0.05 was considered statistically significant. Results: 186 manuscripts were authored by 804 authors. All ICMJE criteria were met by 487/804 (61%) authors. The first and the last author met all the criteria more frequently than those authors in between (P < 0.001). The degree to which ICMJE criteria was met for the first author did not differ between manuscripts authored by only one author and those authored by >1 author (P = 0.859). In 9% of the manuscripts ICMJE criteria were not met by a single author. Authors of the 171/186 manuscripts declared that all persons qualify for authorship but only 49% of them satisfied all ICMJE criteria. Authors have failed to acknowledge contributors in 88/186 (47%) manuscripts; instead these contributors have been listed as authors without fulfilling ICMJE criteria. Authorship violation was not more common in 42 manuscripts with some type of scientific misconduct (P = 0.135). Conclusion: Large proportion of authors of the manuscripts submitted to Biochemia Medica do not fulfil ICMJE criteria. Violation of authorship criteria is not more common for manuscripts with some type of scientific misconduct.
Biochemia Medica, 2015
Recent findings of authorship criteria violations in the manuscripts submitted to Biochemia Medic... more Recent findings of authorship criteria violations in the manuscripts submitted to Biochemia Medica show that almost 40% of authors do not meet necessary criteria for authorship and thus indicate the need for better dissemination of editorial policy on authorship in our journal. We believe that such cases are mostly due to the authors' unawareness or the lack of understanding of the authorship criteria. With this article we therefore wish to declare our editorial policy on authorship and authorship criteria. Biochemia Medica endorses the authorship policy provided by the International Committee of Medical Journal Editors (ICMJE). Information on authorship is assessed by self-reported authorship claims during on-line manuscript submission. Those who meet ICMJE criteria shall be listed as authors, and all listed authors shall fulfill ICMJE criteria. All authors should be responsible for content of the article and have to know other authors' contributions to the study. Biochemia Medica will follow recommendations provided by Committee on Publication Ethics (COPE) flowcharts for possible disputes. By adhering to this procedure we hope to raise awareness about the importance of compliance with ICMJE authorship recommendations.
Clinical Chemistry and Laboratory Medicine (CCLM), 2015
Endogenous interferences are an important source of biased laboratory results. Hemolysis, lipemia... more Endogenous interferences are an important source of biased laboratory results. Hemolysis, lipemia and icteria are the main source of endogenous interference in laboratory medicine. Accreditation according to ISO 15189 improves the overall quality of the laboratory procedures. The aim of our study was i) to assess the level of knowledge of Croatian medical biochemists about the proper detection and management of hemolysis, lipemia and icteria; and ii) to identify possible differences in the level of knowledge respective to the laboratory accreditation status.An on-line self-report survey was carried out by the Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine during April to May 2015. Survey included 14 statements (Q1–Q14) about procedures for samples with interferences and participants were asked to assess the degree of agreement with the statement using a 4-point Likert scale.The lowest level of knowledge was observed for ...
Science and Engineering Ethics, 2015
Instructions for authors (IFA) need to be informative and regularly updated. We hypothesized that... more Instructions for authors (IFA) need to be informative and regularly updated. We hypothesized that journals with a higher impact factor (IF) have more comprehensive IFA. The aim of the study was to examine whether IFA of journals indexed in the Journal Citation Reports 2013, &amp;amp;amp;amp;amp;quot;Medical Laboratory Technology&amp;amp;amp;amp;amp;quot; category, are written in accordance with the latest recommendations and whether the quality of instructions correlates with the journals&amp;amp;amp;amp;amp;#39; IF. 6 out of 31 journals indexed in &amp;amp;amp;amp;amp;quot;Medical Laboratory Technology&amp;amp;amp;amp;amp;quot; category were excluded (unsuitable or unavailable instructions). The remaining 25 journals were scored based on a set of 41 yes/no questions (score 1/0) and divided into four groups (editorial policy, research ethics, research integrity, manuscript preparation) by three authors independently (max score = 41). We tested the correlation between IF and total score and the difference between scores in separate question groups. The median total score was 26 (21-30) [portion of positive answers 0.63 (0.51-0.73)]. There was no statistically significant correlation between a journal&amp;amp;amp;amp;amp;#39;s IF and the total score (rho = 0.291, P = 0.159). IFA included recommendations concerning research ethics and manuscript preparation more extensively than recommendations concerning editorial policy and research integrity (Ht = 15.91, P = 0.003). Some policies were poorly described (portion of positive answers), for example: procedure for author&amp;amp;amp;amp;amp;#39;s appeal (0.04), editorial submissions (0.08), appointed body for research integrity issues (0.08). The IF of the &amp;amp;amp;amp;amp;quot;Medical Laboratory Technology&amp;amp;amp;amp;amp;quot; journals does not reflect a journals&amp;amp;amp;amp;amp;#39; compliance to uniform standards. There is a need for improving editorial policies and the policies on research integrity.
Biochemia Medica, 2014
Peer review is widely used system for evaluating manuscripts prior to publication. It has been an... more Peer review is widely used system for evaluating manuscripts prior to publication. It has been and still is widely used tool for making justified and fair editorial decision. However, the evidence of its efficacy is limited and it has been criticized to be time-consuming, biased, inconsistent, conservative, and open to abuse. As a result, researchers, editors and policymakers have questioned its objectivity and purpose. Nevertheless, this should not be the reason for abandoning the principles of peer review, but to make the additional efforts towards its improvement. Therefore, this Research Integrity Corner aims to describe basic principles of peer review and to introduce Biochemia Medica's guidelines for peer reviewers. Our intention is to help our peer reviewers provide evaluations that are as fair and objective as possible, while helping the journal publish innovative research of the highest quality.
Biochem Med, 2013
Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatme... more Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatment of patients in healthcare. Since laboratory test results are the basis for a large proportion (60-80%) of medical decisions, any error in the phlebotomy process could have serious consequences. In order to minimize the possibility of errors, phlebotomy procedures should be standardised, well-documented and written instructions should be available at every workstation. Croatia is one of the few European countries that have national guidelines for phlebotomy, besides the universally used CLSI (Clinical Laboratory Standards Institute) H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved Standard-Sixth Edition (CLSI, 2007) and WHO (World Health Organization) guidelines on drawing blood: best practices in phlebotomy (WHO, 2010). However, the growing body of evidence in importance of preanalytical phase management resulted in a need for evidence based revision and expansion of existing recommendations. The Croatian Society for Medical Biochemistry and Laboratory Medicine, Working Group for the Preanalytical Phase issued this recommendation. This document is based on the CLSI guideline H3-A6, with signi cant di erences and additional information.
Clinical Chemistry and Laboratory Medicine, 2000
Biochemia Medica, 2013
Plagiarism remains at the top in terms of interest to the scientifi c community. In its many vici... more Plagiarism remains at the top in terms of interest to the scientifi c community. In its many vicious forms, patchwork plagiarism is characterized by numerous unresolved issues and often passes "below the radar" of editors and reviewers. The problem of detecting the complexity of misconduct has been partially resolved by plagiarism detection software. However, interpretation of relevant reports is not always obvious or easy. This article deals with plagiarism in general and patchwork plagiarism in particular, as well as related problems that editors must deal with to maintain the integrity of scientifi c journals.
Clinical Biochemistry, 2015
Despite the standardization of the phlebotomy procedure, blood analysis is occasionally requested... more Despite the standardization of the phlebotomy procedure, blood analysis is occasionally requested after recommended hours with the excuse that the patient is still fasting. We aimed to examine the influence of prolonged fasting and mild physical activity on routine laboratory tests. The study was conducted on 30 volunteers (27 female) median age 40y (20-59). Blood samples were taken in the morning (7:00-8:00a.m.) and early afternoon (1:00-2:00p.m.) after prolonged fasting and usual daily activities. Serum glucose (GLU), urea, creatinine, triglyceride, uric acid (UA), iron and electrolytes were analyzed on Roche cobas 6000 c501 and complete blood count on Siemens ADVIA 2120i. Statistical significance between the two measurements was tested using paired t-test or Wilcoxon test according to data distribution. Clinical significance was judged against calculated reference change values (RCV). A statistically significant decrease was found for red blood cell count, hemoglobin, hematocrit, mean corpuscular volume (MCV), GLU, urea, creatinine, triglycerides and electrolytes, whereas white blood cell count and iron were significantly increased. Judging against desirable bias derived from biological variation, a significant change was found for all the analytes except MCV, platelet count, UA and triglycerides. A clinically significant change was not found for any of the tested analytes when compared to RCV. Prolonged fasting and mild activity will not influence the medical decision for healthy subjects with normal results. Despite the present statistically significant change, the clinically significant change was not shown. However, the study did not include pathological results which have to be interpreted more carefully.
Biochemia Medica
In February 2013, Biodhemia Medica has joined CrossRef, which enabled us to implement CrossCheck ... more In February 2013, Biodhemia Medica has joined CrossRef, which enabled us to implement CrossCheck plagiarism detection service. Therefore, all manuscript submitted to Biodchemia Medica are now first assigned to Research integrity editor (RIE), before sending the manuscript for peer-review. RIE submits the text to CrossCheck analysis and is responsible for reviewing the results of the text similarity analysis. Based on the CrossCheck analysis results, RIE subsequently provides a recommendation to the Editor-in-chief (EIC) on whether the manuscript should be forwarded to peer-review, corrected for suspected parts prior to peer-review or immediately rejected. Final decision on the manuscript is, however, with the EIC. We hope that our new policy and manuscript processing algorithm will help us to further increase the overall quality of our Journal.
Biochem Med, 2011
In tro duc tion: Co bas 6000 (Roc he, Ger ma ny) is bioc he mis try ana lyzer for spec trop ho to... more In tro duc tion: Co bas 6000 (Roc he, Ger ma ny) is bioc he mis try ana lyzer for spec trop ho to met ric, im mu no tur bi di met ric and io n-se lec ti ve de ter mi nation of bioc he mi cal ana lytes. He re by we pre se nt ana lytical va li da tion wi th em pha sis on met hod per for man ce jud gme nt for rou ti ne ope ra tion. Ma te ria ls and met ho ds: Va li da tion was ma de for 30 ana lytes (me ta bo li tes, en zymes, tra ce ele men ts, speci fi c pro tei ns and elec tro lytes). Re sear ch in clu ded de ter mi na tion of withi n-run (N = 20) and be twee n-run im precision (N = 30), inac cu ra cy (N = 30) and met hod com pa ri son wi th rou ti ne ana lyzer (Bec kman Coul ter AU640) (N = 50). For va li da tion of com ple te ana lyti cal pro ce ss we cal cu la ted to tal er ror (TE). Re sul ts we re jud ged ac cording to qua li ty spe ci fi ca tion cri te ria gi ven by Eu ro pean Wor ki ng Group. Re sul ts: Wit hi n-run im pre ci sion CVs we re all be low 5% exce pt for cho les te rol, trig lyce ri des, IgA and IgM. Be twee n-run CVs for all ana lytes we re be low 10%. Ana lytes that did not meet the requi red spe ci fi ca tio ns for im pre ci sion we re: to tal pro tein, al bu min, cal cium, so dium, chlo ri de, im munog lo bu li ns and HDL cho les te rol. Ana lytes that did not ful fi ll requi re men ts for inac cu ra cy we re: to tal pro tein, cal cium, so dium and chlo ri de. Ana lytes that de via ted from qua li ty spe ci fi ca tio ns for to tal er ror were: to tal pro tein, al bu min, cal cium, so dium, chlo ri de and IgM. Pas si ng-Bab lok reg res sion ana lysis pro vi ded li near equa tion and 95% con fi den ce in ter val for in ter ce pt and slo pe. Com ple te ac cor dan ce with rou ti ne ana lyzer Bec kman Coul ter AU640 showed sma ll num ber of ana lytes. Ot her ana lytes showed sma ll pro por tio nal and/or sma ll con sta nt diff e ren ce and the re fo re need to be adjus ted for rou ti ne ope ra tion. Con clu sio ns: Re gar di ng low CV va lues, tes ted analyzer has sa tis fac to ry ac cu ra cy and pre ci sion and is extre me ly stab le. Exce pt for ana lytes that are co he re nt on bo th ana lyze rs, so me ana lytes requi re ad jus tmen ts of slo pe and in ter ce pt for com ple te ac cor dan ce. Key wor ds: vali da tion stu dy; che mis try tec hniques, ana lyti cal; Co bas 6000 ana lyzer; to tal er ror; Pas si ng and Bab lo ck reg res sion Recei ved: Februa ry 15, 2011 Ac cep ted: Ap ril 12, 2011 Va li da tion of met ho ds per for man ce for rou ti ne bioc he mis try ana lytes at Co bas 6000 ana lyzer se ries mo du le c501 1 Cli ni cal In sti tu te of La bo ra to ry Diag nos ti cs, Ri je ka Cli ni cal Hos pi tal Cen ter, Rije ka, Croa tia 2 Depar tme nt of Me di cal In for ma ti cs, Ri je ka Uni ver si ty School of Me di ci ne, Ri je ka, Croa tia
Biochem Med, 2013
Self-plagiarism is a controversial issue in scientifi c writing and presentation of research data... more Self-plagiarism is a controversial issue in scientifi c writing and presentation of research data. Unlike plagiarism, self-plagiarism is diffi cult to interpret as intellectual theft under the justifi cation that one cannot steal from oneself. However, academics are concerned, as self-plagiarized papers mislead readers, do not contribute to science, and bring undeserved credit to authors. As such, it should be considered a form of scientifi c misconduct. In this paper, we explain diff erent forms of self-plagiarism in scientifi c writing and then present good editorial policy toward questionable material. The importance of dealing with self-plagiarism is emphasized by the recently published proposal of Text Recycling Guidelines by the Committee on Publication Ethics (COPE).
Biochem Med, 2010
Se lf re por ted rou ti nes and pro ce du res for the extra-a na lyti cal pha se of la bo ra to r... more Se lf re por ted rou ti nes and pro ce du res for the extra-a na lyti cal pha se of la bo ra to ry prac ti ce in Croa tia -cro ss-sec tio nal sur vey stu dy , No ra Ni ko lac 3 , Lo re na Honović 4 1 Cli ni cal De par tme nt of La bo ra to ry Diag nos ti cs, Ri je ka Cli ni cal Hos pi tal Cen tre, Ri je ka, Croa tia 2 De par tme nt of Me di cal In for ma ti cs, Ri je ka Uni ver si ty School of Me di ci ne, Ri je ka, Croa tia 3 Uni ver si ty De par tme nt of Che mis try, Ses tre Mi los r dni ce Uni ver si ty Hos pi tal, Zag reb, Croa tia 4 La bo ra to ry of Ci ni cal Che mis try, Pu la Ge ne ral Hos pi tal,
Biochemia Medica, 2008
Ca se re po rt of he re di ta ry he mor r ha gic te lan giec ta sia wi th se ve re ane mia 1 Zavo... more Ca se re po rt of he re di ta ry he mor r ha gic te lan giec ta sia wi th se ve re ane mia 1 Zavod za la bo ra to rij sku di jag nos ti ku, Kli nič ki bol nič ki cen tar Ri je ka, Ri je ka 1 In sti tu te of La bo ra to ry Diag nos ti cs, Ri je ka Cli ni cal Hos pi tal Cen ter, Ri je ka, Croa tia 2 Ka ted ra za me di cin sku in for ma ti ku, Me di cin ski fa kul tet Sveu či liš ta u Ri je ci, Ri je ka 2 De par tme nt of Me di cal In for ma ti cs, School of Me di ci ne, Uni ver si ty of Ri je ka, Ri je ka, Croa tia 3 Kli ni ka za unut raš nje bo les ti, Kli nič ki bol nič ki cen tar Ri je ka, Ri je ka 3 De par tme nt of In ter nal Me di ci ne, Ri je ka Cli ni cal Hos pi tal Cen ter, Ri je ka, Croa tia Prih vaće no: 15. siječnja 2008. Ac cep ted: January 15, 2008 Šupak V. i sur. Slu čaj nas ljed ne he mo ra gij ske te lan giek ta zi je Šupak V. et al. Ca se of he re di ta ry he mor r ha gic te lan giec ta sia Šupak V. i sur. Slu čaj nas ljed ne he mo ra gij ske te lan giek ta zi je Šupak V. et al. Ca se of he re di ta ry he mor r ha gic te lan giec ta sia Literatura/References
Biochemia Medica, 2013
Salami publication or segmented publication is a distinct form of redundant publication which is ... more Salami publication or segmented publication is a distinct form of redundant publication which is usually characterized by similarity of hypothesis, methodology or results but not text similarity. These aspects of publications are not objectively detected by software applications and therefore present a serious threat to publication ethics. This article presents a practical approach for dealing with manuscripts suspected of salami publication during the submission process and after article publication in Biochemia Medica.
Clinical Chemistry and Laboratory Medicine, 2000
This cross-sectional multicentric survey study aimed to assess the quality of the extra-analytica... more This cross-sectional multicentric survey study aimed to assess the quality of the extra-analytical phase of laboratory activities in some developing European countries and Mexico. We assessed the quality of the extra-analytical practices in participating laboratories regarding the: a) sample acceptance criteria; b) phlebotomy procedures; c) test results reporting and d) recording non-conformities. A survey was performed during the April-May 2009. A total of 15 clinical laboratories from the following countries were included: Bosnia, Croatia, Czech Republic, Hungary, Mexico, Poland, Portugal, Romania, Serbia and Ukraine. Questions were scored (scores from 1-4) and average scores was calculated for each category. The overall score for all respondents (n = 443) was 3.10 ± 0.33. The average score was 3.11 ± 0.56 for sample acceptance criteria, 2.76 ± 0.58 for phlebotomy and 3.34 ± 0.53, for test results reporting (F = 116.49; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures (F = 16.62; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Moreover, the highest scores for sample acceptance criteria (F = 8.32; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001), phlebotomy procedures (F = 13.28; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001) and for reporting non-conformities (F = 33.62; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001) were observed for accredited laboratories or laboratories under preparation for accreditation. The overall quality of the extra-analytical practices in countries in this survey is not satisfactory. Phlebotomy practices are the most critical extra-analytical activity. Since laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures, we believe that the most significant improvement could be made by implementing the total quality management system and standardizing laboratory procedures.
Biochemia Medica
Informed consent is a process in which a human subject who is to participate in research needs to... more Informed consent is a process in which a human subject who is to participate in research needs to give his or her consent after being properly informed of the expected benefits as well as the potential harm of the research that will be performed. The function and purpose of the research ethics committee is to ensure that the research that will take place is in accordance with the relevant ethical standards. This means that the committee must assess the appropriateness of the design of the study reviewed. Research in the field of laboratory medicine has specific features, i.e. the use of samples that remain after routine analysis, data collection from databases containing patient information, data mining, collection of laboratory management data, method/instrument comparisons and validation, etc. As most of such research is either retrospective or not directly associated with patients, the question arises as to whether all types of research require informed consent and ethics committee approval. This article aims to clarify what is specific about obtaining informed consent and ethical approval in laboratory medicine, to provide general guidance on informed consent and ethical approval requirements based on the type of study, and what information should be included in applications for ethical approval and informed consent. This could also provide some guidance for future contributors to the Biochemia Medica.
Science and engineering ethics, 2015
Instructions for authors (IFA) need to be informative and regularly updated. We hypothesized that... more Instructions for authors (IFA) need to be informative and regularly updated. We hypothesized that journals with a higher impact factor (IF) have more comprehensive IFA. The aim of the study was to examine whether IFA of journals indexed in the Journal Citation Reports 2013, "Medical Laboratory Technology" category, are written in accordance with the latest recommendations and whether the quality of instructions correlates with the journals' IF. 6 out of 31 journals indexed in "Medical Laboratory Technology" category were excluded (unsuitable or unavailable instructions). The remaining 25 journals were scored based on a set of 41 yes/no questions (score 1/0) and divided into four groups (editorial policy, research ethics, research integrity, manuscript preparation) by three authors independently (max score = 41). We tested the correlation between IF and total score and the difference between scores in separate question groups. The median total score was 26 (21...
Biochemia Medica, 2015
Introduction: Our aim was to investigate if: (a) authors of Biochemia Medica meet authorship crit... more Introduction: Our aim was to investigate if: (a) authors of Biochemia Medica meet authorship criteria given by International Committee of Medical Journal Editors (ICMJE), (b) authorship violations are more frequent in submissions containing some type of scientific misconduct. Materials and methods: Self-reported authorship contributions regarding the three ICMJE criteria were analysed for all submissions to Biochemia Medica (February 2013-April 2015) which were forwarded to peer-review. To test the differences in frequencies we used Chi-squared test. P < 0.05 was considered statistically significant. Results: 186 manuscripts were authored by 804 authors. All ICMJE criteria were met by 487/804 (61%) authors. The first and the last author met all the criteria more frequently than those authors in between (P < 0.001). The degree to which ICMJE criteria was met for the first author did not differ between manuscripts authored by only one author and those authored by >1 author (P = 0.859). In 9% of the manuscripts ICMJE criteria were not met by a single author. Authors of the 171/186 manuscripts declared that all persons qualify for authorship but only 49% of them satisfied all ICMJE criteria. Authors have failed to acknowledge contributors in 88/186 (47%) manuscripts; instead these contributors have been listed as authors without fulfilling ICMJE criteria. Authorship violation was not more common in 42 manuscripts with some type of scientific misconduct (P = 0.135). Conclusion: Large proportion of authors of the manuscripts submitted to Biochemia Medica do not fulfil ICMJE criteria. Violation of authorship criteria is not more common for manuscripts with some type of scientific misconduct.
Biochemia Medica, 2015
Recent findings of authorship criteria violations in the manuscripts submitted to Biochemia Medic... more Recent findings of authorship criteria violations in the manuscripts submitted to Biochemia Medica show that almost 40% of authors do not meet necessary criteria for authorship and thus indicate the need for better dissemination of editorial policy on authorship in our journal. We believe that such cases are mostly due to the authors' unawareness or the lack of understanding of the authorship criteria. With this article we therefore wish to declare our editorial policy on authorship and authorship criteria. Biochemia Medica endorses the authorship policy provided by the International Committee of Medical Journal Editors (ICMJE). Information on authorship is assessed by self-reported authorship claims during on-line manuscript submission. Those who meet ICMJE criteria shall be listed as authors, and all listed authors shall fulfill ICMJE criteria. All authors should be responsible for content of the article and have to know other authors' contributions to the study. Biochemia Medica will follow recommendations provided by Committee on Publication Ethics (COPE) flowcharts for possible disputes. By adhering to this procedure we hope to raise awareness about the importance of compliance with ICMJE authorship recommendations.
Clinical Chemistry and Laboratory Medicine (CCLM), 2015
Endogenous interferences are an important source of biased laboratory results. Hemolysis, lipemia... more Endogenous interferences are an important source of biased laboratory results. Hemolysis, lipemia and icteria are the main source of endogenous interference in laboratory medicine. Accreditation according to ISO 15189 improves the overall quality of the laboratory procedures. The aim of our study was i) to assess the level of knowledge of Croatian medical biochemists about the proper detection and management of hemolysis, lipemia and icteria; and ii) to identify possible differences in the level of knowledge respective to the laboratory accreditation status.An on-line self-report survey was carried out by the Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine during April to May 2015. Survey included 14 statements (Q1–Q14) about procedures for samples with interferences and participants were asked to assess the degree of agreement with the statement using a 4-point Likert scale.The lowest level of knowledge was observed for ...
Science and Engineering Ethics, 2015
Instructions for authors (IFA) need to be informative and regularly updated. We hypothesized that... more Instructions for authors (IFA) need to be informative and regularly updated. We hypothesized that journals with a higher impact factor (IF) have more comprehensive IFA. The aim of the study was to examine whether IFA of journals indexed in the Journal Citation Reports 2013, &amp;amp;amp;amp;amp;quot;Medical Laboratory Technology&amp;amp;amp;amp;amp;quot; category, are written in accordance with the latest recommendations and whether the quality of instructions correlates with the journals&amp;amp;amp;amp;amp;#39; IF. 6 out of 31 journals indexed in &amp;amp;amp;amp;amp;quot;Medical Laboratory Technology&amp;amp;amp;amp;amp;quot; category were excluded (unsuitable or unavailable instructions). The remaining 25 journals were scored based on a set of 41 yes/no questions (score 1/0) and divided into four groups (editorial policy, research ethics, research integrity, manuscript preparation) by three authors independently (max score = 41). We tested the correlation between IF and total score and the difference between scores in separate question groups. The median total score was 26 (21-30) [portion of positive answers 0.63 (0.51-0.73)]. There was no statistically significant correlation between a journal&amp;amp;amp;amp;amp;#39;s IF and the total score (rho = 0.291, P = 0.159). IFA included recommendations concerning research ethics and manuscript preparation more extensively than recommendations concerning editorial policy and research integrity (Ht = 15.91, P = 0.003). Some policies were poorly described (portion of positive answers), for example: procedure for author&amp;amp;amp;amp;amp;#39;s appeal (0.04), editorial submissions (0.08), appointed body for research integrity issues (0.08). The IF of the &amp;amp;amp;amp;amp;quot;Medical Laboratory Technology&amp;amp;amp;amp;amp;quot; journals does not reflect a journals&amp;amp;amp;amp;amp;#39; compliance to uniform standards. There is a need for improving editorial policies and the policies on research integrity.
Biochemia Medica, 2014
Peer review is widely used system for evaluating manuscripts prior to publication. It has been an... more Peer review is widely used system for evaluating manuscripts prior to publication. It has been and still is widely used tool for making justified and fair editorial decision. However, the evidence of its efficacy is limited and it has been criticized to be time-consuming, biased, inconsistent, conservative, and open to abuse. As a result, researchers, editors and policymakers have questioned its objectivity and purpose. Nevertheless, this should not be the reason for abandoning the principles of peer review, but to make the additional efforts towards its improvement. Therefore, this Research Integrity Corner aims to describe basic principles of peer review and to introduce Biochemia Medica's guidelines for peer reviewers. Our intention is to help our peer reviewers provide evaluations that are as fair and objective as possible, while helping the journal publish innovative research of the highest quality.
Biochem Med, 2013
Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatme... more Phlebotomy is one of the most complex medical procedures in the diagnosis, management and treatment of patients in healthcare. Since laboratory test results are the basis for a large proportion (60-80%) of medical decisions, any error in the phlebotomy process could have serious consequences. In order to minimize the possibility of errors, phlebotomy procedures should be standardised, well-documented and written instructions should be available at every workstation. Croatia is one of the few European countries that have national guidelines for phlebotomy, besides the universally used CLSI (Clinical Laboratory Standards Institute) H3-A6 Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture; approved Standard-Sixth Edition (CLSI, 2007) and WHO (World Health Organization) guidelines on drawing blood: best practices in phlebotomy (WHO, 2010). However, the growing body of evidence in importance of preanalytical phase management resulted in a need for evidence based revision and expansion of existing recommendations. The Croatian Society for Medical Biochemistry and Laboratory Medicine, Working Group for the Preanalytical Phase issued this recommendation. This document is based on the CLSI guideline H3-A6, with signi cant di erences and additional information.
Clinical Chemistry and Laboratory Medicine, 2000
Biochemia Medica, 2013
Plagiarism remains at the top in terms of interest to the scientifi c community. In its many vici... more Plagiarism remains at the top in terms of interest to the scientifi c community. In its many vicious forms, patchwork plagiarism is characterized by numerous unresolved issues and often passes "below the radar" of editors and reviewers. The problem of detecting the complexity of misconduct has been partially resolved by plagiarism detection software. However, interpretation of relevant reports is not always obvious or easy. This article deals with plagiarism in general and patchwork plagiarism in particular, as well as related problems that editors must deal with to maintain the integrity of scientifi c journals.
Clinical Biochemistry, 2015
Despite the standardization of the phlebotomy procedure, blood analysis is occasionally requested... more Despite the standardization of the phlebotomy procedure, blood analysis is occasionally requested after recommended hours with the excuse that the patient is still fasting. We aimed to examine the influence of prolonged fasting and mild physical activity on routine laboratory tests. The study was conducted on 30 volunteers (27 female) median age 40y (20-59). Blood samples were taken in the morning (7:00-8:00a.m.) and early afternoon (1:00-2:00p.m.) after prolonged fasting and usual daily activities. Serum glucose (GLU), urea, creatinine, triglyceride, uric acid (UA), iron and electrolytes were analyzed on Roche cobas 6000 c501 and complete blood count on Siemens ADVIA 2120i. Statistical significance between the two measurements was tested using paired t-test or Wilcoxon test according to data distribution. Clinical significance was judged against calculated reference change values (RCV). A statistically significant decrease was found for red blood cell count, hemoglobin, hematocrit, mean corpuscular volume (MCV), GLU, urea, creatinine, triglycerides and electrolytes, whereas white blood cell count and iron were significantly increased. Judging against desirable bias derived from biological variation, a significant change was found for all the analytes except MCV, platelet count, UA and triglycerides. A clinically significant change was not found for any of the tested analytes when compared to RCV. Prolonged fasting and mild activity will not influence the medical decision for healthy subjects with normal results. Despite the present statistically significant change, the clinically significant change was not shown. However, the study did not include pathological results which have to be interpreted more carefully.
Biochemia Medica
In February 2013, Biodhemia Medica has joined CrossRef, which enabled us to implement CrossCheck ... more In February 2013, Biodhemia Medica has joined CrossRef, which enabled us to implement CrossCheck plagiarism detection service. Therefore, all manuscript submitted to Biodchemia Medica are now first assigned to Research integrity editor (RIE), before sending the manuscript for peer-review. RIE submits the text to CrossCheck analysis and is responsible for reviewing the results of the text similarity analysis. Based on the CrossCheck analysis results, RIE subsequently provides a recommendation to the Editor-in-chief (EIC) on whether the manuscript should be forwarded to peer-review, corrected for suspected parts prior to peer-review or immediately rejected. Final decision on the manuscript is, however, with the EIC. We hope that our new policy and manuscript processing algorithm will help us to further increase the overall quality of our Journal.
Biochem Med, 2011
In tro duc tion: Co bas 6000 (Roc he, Ger ma ny) is bioc he mis try ana lyzer for spec trop ho to... more In tro duc tion: Co bas 6000 (Roc he, Ger ma ny) is bioc he mis try ana lyzer for spec trop ho to met ric, im mu no tur bi di met ric and io n-se lec ti ve de ter mi nation of bioc he mi cal ana lytes. He re by we pre se nt ana lytical va li da tion wi th em pha sis on met hod per for man ce jud gme nt for rou ti ne ope ra tion. Ma te ria ls and met ho ds: Va li da tion was ma de for 30 ana lytes (me ta bo li tes, en zymes, tra ce ele men ts, speci fi c pro tei ns and elec tro lytes). Re sear ch in clu ded de ter mi na tion of withi n-run (N = 20) and be twee n-run im precision (N = 30), inac cu ra cy (N = 30) and met hod com pa ri son wi th rou ti ne ana lyzer (Bec kman Coul ter AU640) (N = 50). For va li da tion of com ple te ana lyti cal pro ce ss we cal cu la ted to tal er ror (TE). Re sul ts we re jud ged ac cording to qua li ty spe ci fi ca tion cri te ria gi ven by Eu ro pean Wor ki ng Group. Re sul ts: Wit hi n-run im pre ci sion CVs we re all be low 5% exce pt for cho les te rol, trig lyce ri des, IgA and IgM. Be twee n-run CVs for all ana lytes we re be low 10%. Ana lytes that did not meet the requi red spe ci fi ca tio ns for im pre ci sion we re: to tal pro tein, al bu min, cal cium, so dium, chlo ri de, im munog lo bu li ns and HDL cho les te rol. Ana lytes that did not ful fi ll requi re men ts for inac cu ra cy we re: to tal pro tein, cal cium, so dium and chlo ri de. Ana lytes that de via ted from qua li ty spe ci fi ca tio ns for to tal er ror were: to tal pro tein, al bu min, cal cium, so dium, chlo ri de and IgM. Pas si ng-Bab lok reg res sion ana lysis pro vi ded li near equa tion and 95% con fi den ce in ter val for in ter ce pt and slo pe. Com ple te ac cor dan ce with rou ti ne ana lyzer Bec kman Coul ter AU640 showed sma ll num ber of ana lytes. Ot her ana lytes showed sma ll pro por tio nal and/or sma ll con sta nt diff e ren ce and the re fo re need to be adjus ted for rou ti ne ope ra tion. Con clu sio ns: Re gar di ng low CV va lues, tes ted analyzer has sa tis fac to ry ac cu ra cy and pre ci sion and is extre me ly stab le. Exce pt for ana lytes that are co he re nt on bo th ana lyze rs, so me ana lytes requi re ad jus tmen ts of slo pe and in ter ce pt for com ple te ac cor dan ce. Key wor ds: vali da tion stu dy; che mis try tec hniques, ana lyti cal; Co bas 6000 ana lyzer; to tal er ror; Pas si ng and Bab lo ck reg res sion Recei ved: Februa ry 15, 2011 Ac cep ted: Ap ril 12, 2011 Va li da tion of met ho ds per for man ce for rou ti ne bioc he mis try ana lytes at Co bas 6000 ana lyzer se ries mo du le c501 1 Cli ni cal In sti tu te of La bo ra to ry Diag nos ti cs, Ri je ka Cli ni cal Hos pi tal Cen ter, Rije ka, Croa tia 2 Depar tme nt of Me di cal In for ma ti cs, Ri je ka Uni ver si ty School of Me di ci ne, Ri je ka, Croa tia
Biochem Med, 2013
Self-plagiarism is a controversial issue in scientifi c writing and presentation of research data... more Self-plagiarism is a controversial issue in scientifi c writing and presentation of research data. Unlike plagiarism, self-plagiarism is diffi cult to interpret as intellectual theft under the justifi cation that one cannot steal from oneself. However, academics are concerned, as self-plagiarized papers mislead readers, do not contribute to science, and bring undeserved credit to authors. As such, it should be considered a form of scientifi c misconduct. In this paper, we explain diff erent forms of self-plagiarism in scientifi c writing and then present good editorial policy toward questionable material. The importance of dealing with self-plagiarism is emphasized by the recently published proposal of Text Recycling Guidelines by the Committee on Publication Ethics (COPE).
Biochem Med, 2010
Se lf re por ted rou ti nes and pro ce du res for the extra-a na lyti cal pha se of la bo ra to r... more Se lf re por ted rou ti nes and pro ce du res for the extra-a na lyti cal pha se of la bo ra to ry prac ti ce in Croa tia -cro ss-sec tio nal sur vey stu dy , No ra Ni ko lac 3 , Lo re na Honović 4 1 Cli ni cal De par tme nt of La bo ra to ry Diag nos ti cs, Ri je ka Cli ni cal Hos pi tal Cen tre, Ri je ka, Croa tia 2 De par tme nt of Me di cal In for ma ti cs, Ri je ka Uni ver si ty School of Me di ci ne, Ri je ka, Croa tia 3 Uni ver si ty De par tme nt of Che mis try, Ses tre Mi los r dni ce Uni ver si ty Hos pi tal, Zag reb, Croa tia 4 La bo ra to ry of Ci ni cal Che mis try, Pu la Ge ne ral Hos pi tal,
Biochemia Medica, 2008
Ca se re po rt of he re di ta ry he mor r ha gic te lan giec ta sia wi th se ve re ane mia 1 Zavo... more Ca se re po rt of he re di ta ry he mor r ha gic te lan giec ta sia wi th se ve re ane mia 1 Zavod za la bo ra to rij sku di jag nos ti ku, Kli nič ki bol nič ki cen tar Ri je ka, Ri je ka 1 In sti tu te of La bo ra to ry Diag nos ti cs, Ri je ka Cli ni cal Hos pi tal Cen ter, Ri je ka, Croa tia 2 Ka ted ra za me di cin sku in for ma ti ku, Me di cin ski fa kul tet Sveu či liš ta u Ri je ci, Ri je ka 2 De par tme nt of Me di cal In for ma ti cs, School of Me di ci ne, Uni ver si ty of Ri je ka, Ri je ka, Croa tia 3 Kli ni ka za unut raš nje bo les ti, Kli nič ki bol nič ki cen tar Ri je ka, Ri je ka 3 De par tme nt of In ter nal Me di ci ne, Ri je ka Cli ni cal Hos pi tal Cen ter, Ri je ka, Croa tia Prih vaće no: 15. siječnja 2008. Ac cep ted: January 15, 2008 Šupak V. i sur. Slu čaj nas ljed ne he mo ra gij ske te lan giek ta zi je Šupak V. et al. Ca se of he re di ta ry he mor r ha gic te lan giec ta sia Šupak V. i sur. Slu čaj nas ljed ne he mo ra gij ske te lan giek ta zi je Šupak V. et al. Ca se of he re di ta ry he mor r ha gic te lan giec ta sia Literatura/References
Biochemia Medica, 2013
Salami publication or segmented publication is a distinct form of redundant publication which is ... more Salami publication or segmented publication is a distinct form of redundant publication which is usually characterized by similarity of hypothesis, methodology or results but not text similarity. These aspects of publications are not objectively detected by software applications and therefore present a serious threat to publication ethics. This article presents a practical approach for dealing with manuscripts suspected of salami publication during the submission process and after article publication in Biochemia Medica.
Clinical Chemistry and Laboratory Medicine, 2000
This cross-sectional multicentric survey study aimed to assess the quality of the extra-analytica... more This cross-sectional multicentric survey study aimed to assess the quality of the extra-analytical phase of laboratory activities in some developing European countries and Mexico. We assessed the quality of the extra-analytical practices in participating laboratories regarding the: a) sample acceptance criteria; b) phlebotomy procedures; c) test results reporting and d) recording non-conformities. A survey was performed during the April-May 2009. A total of 15 clinical laboratories from the following countries were included: Bosnia, Croatia, Czech Republic, Hungary, Mexico, Poland, Portugal, Romania, Serbia and Ukraine. Questions were scored (scores from 1-4) and average scores was calculated for each category. The overall score for all respondents (n = 443) was 3.10 ± 0.33. The average score was 3.11 ± 0.56 for sample acceptance criteria, 2.76 ± 0.58 for phlebotomy and 3.34 ± 0.53, for test results reporting (F = 116.49; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures (F = 16.62; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Moreover, the highest scores for sample acceptance criteria (F = 8.32; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001), phlebotomy procedures (F = 13.28; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001) and for reporting non-conformities (F = 33.62; p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001) were observed for accredited laboratories or laboratories under preparation for accreditation. The overall quality of the extra-analytical practices in countries in this survey is not satisfactory. Phlebotomy practices are the most critical extra-analytical activity. Since laboratory accreditation was associated with better practices and higher overall quality of the extra-analytical procedures, we believe that the most significant improvement could be made by implementing the total quality management system and standardizing laboratory procedures.