Autovalidation and automation of the postanalytical phase of routine hematology and coagulation analyses in a university hospital laboratory.

BACKGROUND: The need to satisfy high-throughput demands for laboratory tests continues to be a challenge. Therefore, we aimed to automate postanalytical phase in hematology and coagulation laboratory by autovalidation of complete blood count (CBC) and routine coagulation test results (prothrombin time [PT], international normalized ratio [PT-INR], activated partial thromboplastin time [APTT], fibrinogen, antithrombin activity [AT] and thrombin time [TT]). Work efficacy and turnaround time (TAT) before and after implementation of automated solutions will be compared. METHODS: Ordering panels tailored to specific patient populations were implemented. Rerun and reflex testing rules were set in the respective analyzers' software (Coulter DxH Connectivity 1601, Beckman Coulter, FL, USA; AutoAssistant, Siemens Healthcare Diagnostics, Germany), and sample status information was transferred into the laboratory information system. To evaluate if the automation improved TAT and efficacy, data from manually verified results in September and October of 2015 were compared with the corresponding period in 2016 when autovalidation was implemented. RESULTS: Autovalidation rates of 63% for CBC and 65% for routine coagulation test results were achieved. At the TAT of 120 min, the percentage of reported results increased substantially for all analyzed tests, being above 90% for CBC, PT, PT-INR and fibrinogen and 89% for APTT. This output was achieved with three laboratory technicians less compared with the period when the postanalytical phase was not automated. CONCLUSIONS: Automation allowed optimized laboratory workflow for specific patient populations, thereby ensuring standardized results reporting. Autovalidation of test results proved to be an efficient tool for improvement of laboratory work efficacy and TAT.

An Analysis of Medical Laboratory Technology Journals' Instructions for Authors.

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 (21-30) [portion of positive answers 0.63 (0.51-0.73)]. There was no statistically significant correlation between a journal'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's appeal (0.04), editorial submissions (0.08), appointed body for research integrity issues (0.08). The IF of the "Medical Laboratory Technology" journals does not reflect a journals' compliance to uniform standards. There is a need for improving editorial policies and the policies on research integrity.

Effect of sample processing and time delay on cell count and chemistry tests in cerebrospinal fluid collected from drainage systems.

INTRODUCTION: Cerebrospinal fluid (CSF) from extra-ventricular drainage (EVD) systems is routinely analysed to diagnose EVD-related bacterial meningitis. We investigated the effect of time delay and sample processing on cell count and basic biochemistry results in EVD CSF to define optimal turnaround time and whether manual and automated cell counting are comparable in such samples. MATERIALS AND METHODS: In total, 32 EVD CSF samples were analysed. Baseline testing included cell counting (Fuchs-Rosenthal chamber and Sysmex XE5000) and biochemistry analyses (glucose, lactate, proteins). Manual cell counting was also performed at intervals of 61-90 and 91-150 minutes from baseline in the residual sample. Biochemistry analyses were performed in samples before and after centrifugation at baseline and at 91-150 minutes interval. RESULTS: At 91-150 minutes total cell count (P < 0.001), large lymphocytes (P = 0.007), neutrophils (P < 0.001) and phagocytes (P = 0.006) obtained by manual counting decreased and the number of disintegrated cells count increased (P = 0.016) compared to the baseline values. Considering method comparison, proportional difference between methods for all cell (sub)groups was obtained, whereas polymorphonuclears also showed the constant difference (y = 11.21 + 1.22x). Compared to centrifuged CSF, lower concentration of glucose and lactates were obtained in uncentrifuged samples (P < 0.001) at baseline. CONCLUSIONS: Manual cell counting should be performed within 60 minutes as any delay can alter results. The same counting technique should be used to obtain longitudinally assessable results. Biochemistry tests are stable in uncentrifuged CSF up to 2.5 hours.

Informed consent and ethics committee approval in laboratory medicine.

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.

Effect of different pre-analytical conditions on plasma lactate concentration.

INTRODUCTION: Plasma lactate is a frequently used and important parameter for medical decision making. To setup a pre-analytical algorithm, we aimed to investigate the influence of different test tube additives, aliquoting, ice storage and haemolysis on plasma lactate concentrations for possible sparing critically ill (ICU) patients of additional blood drawing. MATERIALS AND METHODS: In our study (N = 177), lactate concentration and haemolysis index (HI) were measured in aliquoted (AHP) and unaliquoted (HP) Li-heparin, NaF/K3EDTA and NaF/KOX plasma, centrifuged within 15 minutes after venipuncture, on Cobas c501 analyzer. Differences were tested using the Wilcoxon's test and Passing-Bablok regression. Clinical accuracy of results was assessed in 107 ICU patients based on reference interval and clinical decision limits. RESULTS: Lactate concentrations did not differ in NaF/K3EDTA and NaF/KOX plasma (P = 0.855). No clinically significant difference of AHP compared to NaF/K3EDTA lactate was found (y = 0.13 (0.08 to 0.19) + 1.02 (0.99 to 1.08) x) if samples were aliquoted within 30 minutes after venipuncture. On contrary, lactate concentrations in HP showed significant proportional difference (y = 0.07 (- 0.12 to 1.24) + 1.37 (1.22 to 1.56) x) and were clinically incorrect in 14% of patients. Transport in ice bath increases HI in NaF/K3EDTA (P < 0.001), but without influencing lactate results compared to room temperature (y = 0.03 (- 0.06 to 1.00) + 1.05 (0.99 to 1.11) x). CONCLUSIONS: Lactate determination in HP is unacceptable because of high proportional error and high risk of clinical inaccuracy compared to NaF/K3EDTA. If pre-analytical conditions are met, AHP, NaF/K3EDTA and NaF/KOX plasma can be used interchangeably. Aliquoted Li-heparin samples alow measurement of other biochemical tests from a single tube and can spare ICU patients from additional blood drawing. Storage in ice bath provides no additional stabilization in NaF/K3EDTA tubes.

Dealing with the positive publication bias: Why you should really publish your negative results.

Studies with positive results are greatly more represented in literature than studies with negative results, producing so-called publication bias. This review aims to discuss occurring problems around negative results and to emphasize the importance of reporting negative results. Underreporting of negative results introduces bias into meta-analysis, which consequently misinforms researchers, doctors and policymakers. More resources are potentially wasted on already disputed research that remains unpublished and therefore unavailable to the scientific community. Ethical obligations need to be considered when reporting results of studies on human subjects as people have exposed themselves to risk with the assurance that the study is performed to benefit others. Some studies disprove the common conception that journal editors preferably publish positive findings, which are considered as more citable. Therefore, all stakeholders, but especially researchers, need to be conscious of disseminating negative and positive findings alike.

ICMJE authorship criteria are not met in a substantial proportion of manuscripts submitted to Biochemia Medica.

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.