Establishing paediatric reference intervals for thyroid function tests in Croatian population on the Abbott Architect i2000

IntroductionEvaluation of thyroid function is often requested and therefore defining paediatric reference intervals (RIs) is of vital importance. Currently, there is a distinct lack of paediatric RIs for thyroid function tests in Croatia. Thus, we established RIs for thyroid stimulating hormone (TSH), total triiodothyronine (TT3), total thyroxine (TT4), free triiodothyronine (FT3) and free thyroxine (FT4) in the Croatian paediatric population.Materials and methodsReference intervals were calculated from 397 apparently healthy children, aged from 2 days to < 19 years. Serum samples were analysed for thyroid function tests on the Abbott Architect i2000. Age- and sex-specific 95% RIs with 90% confidence intervals were established according to Clinical and Laboratory Standards Institute guidelines. To express the magnitude of sex and age variation, standard deviation ratio (SDR) was calculated using two-level nested ANOVA. The criterion for considering partitioning reference values was set to SDR > 0.3.ResultsAll thyroid function tests required age partitioning, confirmed by SDR above 0.3. There was no need for sex partitioning, confirmed by SDR below 0.3. Still, FT3 was partitioned due to visually noticeable sex related difference for the oldest group (12 years to < 19 years).ConclusionThis is the first study to establish RIs for thyroid function tests in the Croatian paediatric population. We propose RIs for widely used Abbott platform, thus giving laboratories method- and population-specific paediatric RIs for thyroid function tests that should improve clinical test interpretation.     

Nationwide survey of policies and practices related to capillary blood sampling in medical laboratories in Croatia

Introduction:

Capillary sampling is increasingly used to obtain blood for laboratory tests in volumes as small as necessary and as non-invasively as possible. Whether capillary blood sampling is also frequent in Croatia, and whether it is performed according to international laboratory standards is unclear.

Materials and methods:

All medical laboratories that participate in the Croatian National External Quality Assessment Program (N = 204) were surveyed on-line to collect information about the laboratory’s parent institution, patient population, types and frequencies of laboratory tests based on capillary blood samples, choice of reference intervals, and policies and procedures specifically related to capillary sampling. Sampling practices were compared with guidelines from the Clinical and Laboratory Standards Institute (CLSI) and the World Health Organization (WHO).

Results:

Of the 204 laboratories surveyed, 174 (85%) responded with complete questionnaires. Among the 174 respondents, 155 (89%) reported that they routinely perform capillary sampling, which is carried out by laboratory staff in 118 laboratories (76%). Nearly half of respondent laboratories (48%) do not have a written protocol including order of draw for multiple sampling. A single puncture site is used to provide capillary blood for up to two samples at 43% of laboratories that occasionally or regularly perform such sampling. Most respondents (88%) never perform arterialisation prior to capillary blood sampling.

Conclusions:

Capillary blood sampling is highly prevalent in Croatia across different types of clinical facilities and patient populations. Capillary sampling procedures are not standardised in the country, and the rate of laboratory compliance with CLSI and WHO guidelines is low.     

Verification policies in Croatian medical biochemistry laboratories: a survey of the practice

IntroductionThe aim of this study was to screen practices used in verification procedures for methods/analysers among medical biochemistry laboratories (MBLs) in Croatia. We hypothesized that these procedures differ widely from laboratory to laboratory and wanted to gather specific data on steps used in the verification workflow.Materials and methodsIn order to obtain data, an online survey was conducted. The survey, divided in two sections, contained 29 questions and statements addressing general characteristics and specific steps of the verification workflow of each individual MBL. The survey was disseminated among managers of all MBLs in Croatia.ResultsA total of 108/196 (55%) laboratories participated in the survey. Forty nine MBLs were excluded from the second part of the survey: 14 have not implemented verification procedures, and 35 MBLs due to the absence of answers. The most relevant results of the second part of the survey showed that: 18/59 (0.31) of the responding MBLs have difficulties when defining acceptance criteria, 27/59 (0.46) used the Clinical and Laboratory Standards Institute protocol for precision estimation; the majority of MBLs used a median of 20 samples for method/analyser comparisons and estimated bias using internal quality control samples; reference intervals provided by external sources are mainly adopted; 60% of MBLs do not include linearity verification in their protocol and do not use the national document for the estimation of measurement uncertainty.ConclusionsHeterogeneous verification protocols are routinely utilized across Croatian MBLs which clearly confirms that a national document might help in the harmonization of verification procedures.     

Laboratory diagnostics of chronic kidney disease in Croatia: state of the art: On behalf of the joint working group of Croatian society of medical biochemistry and laboratory medicine and Croatian chamber for medical biochemists for laboratory diagnostics in chronic kidney disease

Introduction

Early identification and management of chronic kidney disease (CKD) is highly cost-effective and can reduce the risk of kidney failure progression and cardiovascular disease. In 2014, the Joint Croatian Working Group (JCWG) for laboratory diagnostic of CKD on the behalf of Croatian society of medical biochemistry and laboratory medicine (CSMBLM) and Croatian chamber of medical biochemists (CCMB) conducted a survey across Croatian medical-biochemistry laboratories to assess the current practice in this area of laboratory medicine. The aim of this study was to present the data collected through the survey and to give insight about laboratory diagnostics of chronic kidney disease in Croatia.

Materials and methods

An invitation to participate in the survey was sent to all Croatian medical-biochemistry laboratories (N = 196). The questionnaire was designed in a form of questions and statements, with possible multiple answers, comprising 24 questions.

Results

The response rate was 80/196 (40.8%). 39 answers were from primary medical-biochemistry laboratories. 31/78 (0.40) laboratories measure creatinine with non-standardized method (uncompensated Jaffe method). 58/78 (0.74) of laboratories that measure creatinine do not report eGFR values. Similar number of laboratories (58/80, 0.73) do not measure urine albumin or protein.

Conclusions

There is a large heterogeneity among Croatian laboratories regarding measuring methods, reporting units and reference intervals (cut-off values), both for creatinine and urine albumin or protein. The two key prerequisites for CKD screening, automatic reporting of eGFR and albuminuria or proteinuria assessment, are not implemented nationwide. There is a need for harmonization in laboratory diagnostics of CKD in Croatia.Key words: survey, chronic kidney disease, estimated glomerular filtration rate (eGFR), albuminuria, proteinuria, creatinine, harmonization     

Institutional practices and policies in acid-base testing: a self reported Croatian survey study on behalf of the Croatian society of medical biochemistry and laboratory medicine Working Group for acid-base balance

Introduction:

The aim of this survey study was to assess the current practices and policies in use related to the various steps in the blood gas testing process, across hospital laboratories in Croatia.

Materials and methods:

First questionnaire was sent by email to all medical biochemistry laboratories (N = 104) within general, specialized and clinical hospitals and university hospital centres to identify laboratories which perform blood gas analysis. Second questionnaire with detailed questions about sample collection, analysis and quality control procedures, was sent only to 47 laboratories identified by the first survey. Questionnaire was designed as combination of questions and statements with Likert scale. Third questionnaire was sent to all participating laboratories (N=47) for additional clarification for either indeterminate or unclear answers.

Results:

Blood gas analysis is performed in 47/104 hospital laboratories in Croatia. In 25/41 (0.61) of the laboratories capillary blood gas sampling is the preferred sample type for adult patient population, whereas arterial blood sample is preferentially used in only 5/44 laboratories (0.11). Blood sampling and sample processing for capillary samples is done almost always by laboratory technicians (36/41 and 37/44, respectively), whereas arterial blood sampling is almost always done by the physician (24/29) and only rarely by a nurse (5/28). Sample acceptance criteria and sample analysis are in accordance with international recommendations for majority of laboratories. 43/44 laboratories participate in the national EQA program. POCT analyzers are installed outside of the laboratory in 20/47 (0.43) institutions. Laboratory staff is responsible for education and training of ward personnel, quality control and instrument maintenance in only 12/22, 11/20 and 9/20 institutions, respectively.

Conclusions:

Practices related to collection and analysis for blood gases in Croatia are not standardised and vary substantially between laboratories. POCT analyzers are not under the direct supervision by laboratory personnel in a large proportion of surveyed institutions. Collective efforts should be made to harmonize and improve policies and procedures related to blood gas testing in Croatian laboratories.     

Reporting of activated partial thromboplastin time (aPTT): Could we achieve better comparability of the results?

IntroductionActivated partial thromboplastin time (aPTT) is determined and reported as clotting time in seconds aPTT(s), but it is presumed that reporting results as patient-to-normal clotting time ratio, aPTT(r), could minimize within-laboratory variability. The aim of study was to investigate differences in reporting aPTT results that can affect comparability of the results among Croatian laboratories and suggest further steps for its harmonization.Materials and methodsThe questionnaire on aPTT reporting practice was distributed to 83 laboratories through Survey Monkey application in March 2019 as the part of the first regular round of Croatian Centre for Quality Assessment in Laboratory Medicine proficiency testing.ResultsThe survey response rate was 0.49. Majority of laboratories report aPTT results as both, seconds and ratio. Participants reported use of 23 different aPTT(s) reference intervals along with 17 different combinations of reagent/coagulometer and 25 aPTT(s) denominators of different origin for aPTT(r) calculation. Despite the same aPTT(s) results, the use of different denominators caused a dispersion of aPTT(r) results that can lead to exceeding external quality assessment performance criteria of 7%, particularly when results were compared for the same reagent group only. By applying aPTT(s) reference interval mean as denominator for calculation of aPTT(r) reference interval better concordance to harmonized one was obtained (17 vs. 27; χ² = 3.972; P = 0.046).ConclusionIn order to improve comparability of the results, laboratories are advised to use mean of aPTT(s) reference interval as denominator for aPTT(r) calculation. Type of coagulometer need to be considered when evaluating aPTT proficiency test results and its currently acceptable limit of performance evaluated accordingly.     

The concurrence of the current postanalytical phase management with the national recommendations: a survey of the Working Group for Postanalytics of the Croatian Society of Medical Biochemistry and Laboratory Medicine

IntroductionThe detection and prevention of errors in the postanalytical phase can be done through the harmonization and standardization of constituent parts of this phase of laboratory work. The aim was to investigate how well the ongoing management of the postanalytical phase corresponds to the document “Post-analytical laboratory work: national recommendations” in Croatian medical biochemistry laboratories (MBLs).Materials and methodsAll 195 MBLs participating in the national external quality assessment scheme, were invited to undertake a part in a survey. Through 23 questions the participants were asked about management of the reference intervals (RI), delta check, reflex/reflective testing, postanalytical quality indicators and other parts of the postanalytical phase recommended in the national recommendations. The results are presented in numbers and percentages.ResultsOut of 195 MBLs, 119 participated in the survey, giving a response rate of 61%. Not all of the respondents provided answers to all the questions. Delta check has not been used in 59% (70/118) of the laboratories. Only 22/113 (20%) laboratories use reflex and/or reflective testing. In 53% of the laboratories, critical results were reported within 30 minutes of the confirmation of the results. In 34% (40/118) of the laboratories, turnaround time and reporting of critical results are two most often monitored postanalytical quality indicators.ConclusionThe results showed the critical results reporting and monitoring of postanalytical quality indicators are in the line with the recommendations. However, the management of RI verification, the use of delta check and reflex/reflective testing still must be harmonized among Croatian MBLs.     

Croatian Society of Medical Biochemistry and Laboratory Medicine: national recommendations for venous blood sampling

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 significant differences and additional information.     

Validation Protocol: First Step of a Lean-Total Quality Management Principle in a New Laboratory Set-up in a Tertiary Care Hospital in India

Method validation is pursued as the first step in establishing Lean-Total Quality Management in a new clinical laboratory, in order to eliminate error in test results. Validation of all the new tests were done (with particular reference to alkaline phosphatase) by verifying reference intervals, analytical accuracy and precision, inter-assay and intra-assay variations, analytical sensitivity, limit of detection, linearity and reportable range, i.e. (i) Analytical measurement range (AMR) and (ii) Clinically reportable range (CRR). Our obtained reference range was within that of the manufacturer’s and showed high degree of analytical accuracy between two laboratories (r ² = 0.99). Precision was comparable with the manufacturer’s claim with inter-assay variation CV 1.04% and intra-assay variation CV 1.54%. Lowest limit of detection was 1.0324 ± 0.007 with CV 0.34%. AMR was also verified with CV 1.26 and 0.69%, for level 1 and level 2 control sera, respectively. The assay was linear with different dilutions. Lean concept was also verified with high recovery percentage. Validation ensures that accurate and precise results are reported in a clinically relevant turn around time.     

Croatian survey on critical results reporting

Introduction

Poor harmonization of critical results management is present in various laboratories and countries, including Croatia. We aimed to investigate procedures used in critical results reporting in Croatian medical biochemistry laboratories (MBLs).

Materials and methods

An anonymous questionnaire, consisting of 24 questions/statements, related to critical results reporting procedures, was send to managers of MBLs in Croatia. Participants were asked to declare the frequency of performing procedures and degree of agreement with statements about critical values reporting using a Likert scale. Total score and mean scores for corresponding separate statements divided according to health care setting were calculated and compared.

Results

Responses from 111 Croatian laboratories (48%) were analyzed. General practice laboratories (GPLs) more often re-analyzed the sample before reporting the critical result in comparison with the hospital laboratories (HLs) (score: 4.86 (4.75-4.96) vs. 4.49 (4.25-4.72); P = 0.001) and more often reported the critical value exclusively to the responsible physician compared to HLs (4.46 (4.29-4.64) vs. 3.76 (3.48-4.03), P < 0.001). High total score (4.69 (4.56-4.82)) was observed for selection of the critical results list issued by the Croatian Chamber of Medical Biochemistry (CCMB) indicating a high harmonization level for this aspect of critical result management. Low total scores were observed for the statements regarding data recording and documentation of critical result notification.

Conclusions

Differences in practices about critical results reporting between HLs and GPLs were found. The homogeneity of least favorable responses detected for data recording and documentation of critical results notification reflects the lack of specific national recommendations.Key words: critical results, laboratory testing, quality indicators, survey, post-analytical phase     

Performance evaluation of the high sensitive troponin I assay on the Atellica IM analyser

IntroductionThe Fourth Universal Definition of Myocardial Infarction Global Taskforce recommends the use of high sensitive troponin (hs-Tn) assays in the diagnosis of acute myocardial infarction. We evaluated the analytical performance of the Atellica IM High-sensitivity Troponin I Assay (hs-TnI) (Siemens Healthcare Diagnostics Inc., Tarrytown, USA) and compared its performance to other hs-TnI assays (Siemens Advia Centaur, Dimension Vista, Dimension EXL, and Abbott Architect (Wiesbaden, Germany)) at one or more sites across Europe.Materials and methodsPrecision, detection limit, linearity, method comparison, and interference studies were performed according to Clinical and Laboratory Standards Institute protocols. Values in 40 healthy individuals were compared to the manufacturer’s cut-offs. Sample turnaround time (TAT) was examined.ResultsImprecision repeatability CVs were 1.1–4.7% and within-lab imprecision were 1.8–7.6% (10.0–25,000 ng/L). The limit of blank (LoB), detection (LoD), and quantitation (LoQ) aligned with the manufacturer’s values of 0.5 ng/L, 1.6 ng/L, and 2.5 ng/L, respectively. Passing-Bablok regression demonstrated good correlations between Atellica IM analyser with other systems; some minor deviations were observed. All results in healthy volunteers fell below the 99th percentile URL, and greater than 50% of each sex demonstrated values above the LoD. No interference was observed for biotin (≤ 1500 µg/L), but a slight bias at 5.0 g/L haemoglobin and 50 ng/L Tn was observed. TAT from was fast (mean time = 10.9 minutes) and reproducible (6%CV).ConclusionsReal-world analytical and TAT performance of the hs-TnI assay on the Atellica IM analyser make this assay fit for routine use in clinical laboratories.     

Interpretative comments - need for harmonization? Results of the Croatian survey by the Working Group for Post-analytics

IntroductionInterpretation of laboratory test results is a complex post-analytical activity that requires not only understanding of the clinical significance of laboratory results but also the analytical phase of laboratory work. The aims of this study were to determine: 1) the general opinion of Croatian medical biochemistry laboratories (MBLs) about the importance of interpretative comments on laboratory test reports, and 2) to find out whether harmonization of interpretative comments is needed.Materials and methodsThis retrospective study was designed as a survey by the Working Group for Post-analytics as part of national External Quality Assessment (EQA) program. All 195 MBLs participating in the national EQA scheme, were invited to participate in the survey. Results are reported as percentages of the total number of survey participants.ResultsOut of 195 MBLs, 162 participated in the survey (83%). Among them 59% MBLs implemented test result comments in routine according to national recommendations. The majority of laboratories (92%) state that interpretative comments added value to the laboratory reports, and a substantial part (72%) does not have feedback from physicians on their significance. Although physicians and patients ask for expert opinion, participants stated that the lack of interest of physicians (64%) as well as the inability to access patient’s medical record (62%) affects the quality of expert opinion.ConclusionAlthough most participants state that they use interpretative comments and provide expert opinions regarding test results, results of the present study indicate that harmonization for interpretative comments is needed.     

National Guidelines for the Performance of the Sweat Test in Diagnosis of Cystic Fibrosis on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine and the Cystic Fibrosis Centre - Paediatrics and adults,University Hospital Centre Zagreb

The sweat test (ST) is a cornerstone in the diagnosis of cystic fibrosis (CF), together with newborn screening and genetic testing. However, the performance of the ST can depend on the operator’s skill, so several international guidelines have been published to standardise the ST, but inconsistencies remain. The joint Working Group for ST Standardisation (WG STS) of the Croatian Society of Medical Biochemistry and Laboratory Medicine, in association with cistic fybrosis health professional and the Cistic Fibrosis Centre for Paediatrics and Adults, have issued National Guidelines for the Performance of the Sweat Test in order to ensure consistency in ST performance and accuracy of reported results. Many of the standards were taken from the 2nd Edition of the UK Guidelines for Performance of the ST for the Diagnosis of CF, while others were taken from independent consensus statements from the WG STS based on local ST equipment and practices. The standards cover every step of the ST, from the indications for testing to reporting of results and their interpretation, including the analytical phase and quality control. In addition, National Guidelines include appendices with practical examples in order to aid implementation of the recommendations in routine practice.     

Thyroid disorders in women of Puducherry

Thyroid stimulating hormone (TSH), Free Thyroxine (FT₄) and Free Triiodothyronine (FT₃) were assayed in 505 women of this region. 60 women had previous history of thyroid disease. The remaining 445 women formed the “Disease free group”. A “Reference group” was obtained by excluding women with previous and present history of thyroid dysfunction. Of the total 505 women examined 15.8% had thyroid dysfunction and 84.2% were euthyroid. 11.5% were hypothyroid (9.5% sub-clinical) and 1.8% hyperthyroid (1.2% clinical). The geometric mean TSH for the total population was 2.65 μIU/ml. It was significantly (p=0.025) lower in the reference population 2.17 μIU/ml. There was no significant difference in the FT₃ and FT₄ values between groups. 19% of women over 60 years had elevated TSH above 4.5 μIU/ml. The 2.5 and 97.5 percentiles of the reference population was 1.1–5.2 μIU/ml. 6.1% of women in the reference group had TSH levels above the reference intervals. Hypothyroidism particularly sub-clinical hypothyroidism is predominantly present amongst women in this iodine sufficient region. Evaluation of thyroid status could help in early detection and treatment.     

External quality assessment of RIA for thyroid related hormones

An external quality assessment was conducted for RIA of thyroid related hormones. Thirtyfive laboratories (35 for T₄, 34 for T₃ and 23 for TSH) from different parts of country participated in the programme. Twentyfour samples (16 pools: 5 simple and 11 manipulated pools) in 8 batches, 3 per batch per month were sent for analysis of T₄, T₃ and TSH. Some of the samples were repeated 3 times at different occasions to assess the imprecision of the laboratory. The overall mean percent CV obtained for T₄, T₃ and TSH were 22.7, 36.32 and 52.38 respectively. The recovery for added T₄ was 86.73% while that for T₃ was 117.4%. A large variation was obtained for recovery of TSH. For T₄ estimations, 13 laboratories had a desirable performance i. e. bias less than ±10.0% and variability of bias (VB) and imprecision (IP) less than 15.0%. None of the laboratories had a desirable performance for T₃ or TSH. The number of laboratories with acceptable performance i. e. bias between ±10.0–15.0%, VB and IP between 20.0–25.0% for T₄, T₃ and TSH were 4, 3 and 0 respectively. The number of laboratories which required attention (bias between ±15.0–20.0%; VB and IP between 20.0–25.0%) were 5,7 and 1 respectively. The unacceptable results with larger bias, VB and IP for T₄, T₃ and TSH were 6, 18 and 17 respectively. Our results are in general agreement that the performance of T₄ assay is better than T₃ and both in turn are much better than TSH. Quantitation of circulating thyroid hormones (TH) viz. tri-iodothyronine (T₃), thyroxine (T₄) and thyroid stimulating hormone (TSH), which form the largest percentage of hormones estimated in a clinical laboratory is mainly done by radio-immunoassay (RIA) procedures. The reliability and reproducibility of these assays are generally monitored by using internal quality control (IQC) samples in every assay batch. Thus, the IQC provides information whether the assay results are satisfactory and can be released. However, external quality assessment (EQA) is a procedure whereby an external agency undertakes evaluation of the quality of an analytical service by providing samples for analysis to individual laboratories performing the assay. The data gathered is analysed collectively. EQA therefore provides a means by which performance of a laboratory is assessed in relation to other laboratories and matching the assay unbiased by removing systematic error, if present. This is important since RIA procedure involves several steps (collection and storage of samples, quality of the reagents, procedure followed for performance of an assay, counting equipment used and the mode of the data analysis) and therefore prone to systematic errors. We therefore undertook the EQA programme for assessment of thyroid related hormones as a joint collaborative project of Bhabha Atomic Research Centre, India and International Atomic Energy Agency.     

Laboratory professionals’ attitudes towards ISO 15189:2012 accreditation: an anonymous survey of three Croatian accredited medical laboratories

IntroductionEffective implementation and continual compliance with ISO 15189:2012 require ongoing commitment and active involvement of laboratory staff. Our aim was to assess attitudes regarding accreditation implementation by conducting a survey in three Croatian accredited medical laboratories.Materials and methodsAn anonymous survey consisting of 34 questions was distributed either electronically or in a paper form a week prior to scheduled annual audits. Distributions of answers regarding age, work experience, laboratory workplace, and education level and according to the respective laboratory were compared.ResultsThe overall response rate was 76% (225/297). Preference towards working in an accredited laboratory and a positive attitude were revealed by 70% and 56% participants, respectively, with better process documentation as the main advantage. Only 14% of responders considered themselves completely familiar with ISO 15189:2012. Total of 68% of responders felt that accreditation increases the usual workload, with excessive paperwork as the main contributor. Half of the responders declared partial agreement that accreditation requirements and expectations were clearly explained and claimed that their suggestions were taken into account only occasionally, which was especially emphasized by technical staff. The vast majority (89%) completely follow the prescribed protocols. Only 27% consider turnaround time monitoring useful. Competence assessment is considered efficient by 41% of responders. The majority (73%) prefer an online audit in times of COVID-19.ConclusionsDespite an overall positive attitude towards accreditation, further efforts are needed in providing better education about ISO 15189:2012 for technical staff and modifying formats of competence assessment, in order to achieve better adherence to ISO 15189:2012 requirements.     

How compliant are technicians with universal safety measures in medical laboratories in Croatia? – A pilot study

Introduction

This pilot study aimed to investigate the use of personal protective equipment (PPE) and compliance to the code of conduct (rules defined in institutional, governmental and professional guidelines) among laboratory technicians in Croatian medical laboratories. In addition, we explored the differences in compliance between participants of different age groups, laboratory ownership and accreditation status.

Materials and methods

An anonymous and voluntary survey with 15 questions was conducted among Croatian medical laboratory technicians (N = 217). The questions were divided into two groups: demographic characteristics and the use of PPE. The questions of the second part were graded according to the Likert scale (1-4) and an overall score, shown as median and range (min-max), was calculated for each participant. Differences between the overall scores were tested for each group of participants.

Results

The majority of participants always wear protective clothes at work, 38.7% of them always wear gloves in daily routine, more than 30.0% consume food and almost half of them drink beverages at workplace. A significantly lower overall score was found for participants working in public compared to private laboratories (36 (16-40) vs. 40 (31-40), P < 0.001). There were no statistically significant differences in overall scores for participants of different age groups (P = 0.456) and laboratory accreditation status (P = 0.081).

Conclusion

A considerable percentage of laboratory technicians in Croatian medical laboratories do not comply with safety measures. Lack of compliance is observed in all personnel regardless laboratory accreditation and participants’ age. However, those working in private laboratories adhere more to the code of conduct.Key words: survey, compliance, laboratory technician, universal safety measures, total quality management, clinical laboratory services     

Assessment of antinuclear antibodies (ANA): National recommendations on behalf of the Croatian society of medical biochemistry and laboratory medicine

Antinuclear antibodies (ANA) represent a family of autoantibodies targeting ubiquitous cellular constituents and are a hallmark of systemic inflammatory autoimmune rheumatic diseases named connective tissue diseases (CTD). The gold standard method for ANA determination is indirect immunofluorescence (IIF) on the human laryngeal epidermoid carcinoma cell line type 2 substrate (HEp-2), but with increasing demand for ANA testing, novel methods eased for automation emerged, which allows testing by staff less experienced in this specific field of laboratory diagnostic. In 2016 The working group (WG) for laboratory diagnostics of autoimmune diseases as part of the Committee for the Scientific Professional Development of the Croatian Society of Medical Biochemistry and Laboratory Medicine (CSMBLM) published the data of a survey regarding general practice in laboratory diagnostics of autoimmune diseases in Croatia. Results indicated high diversity in the performance of autoantibody testing as well as reporting of the results and indicated the need of creating recommendations for the assessment of ANA that would help harmonize diagnostics of systemic autoimmune rheumatic diseases in Croatia. This document encompasses twenty-seven recommendations for ANA testing created concerning indications for ANA testing, preanalytical, analytical, and postanalytical issues, including rational algorithm and quality control assurance. These recommendations are based on the relevant international recommendations and guidelines for the assessment of ANA testing and relevant literature search and should help to harmonize the approach in ANA testing and clarify differences in interpretation of the results obtained using different methods of determination.     

Women in sports: the applicability of common national reference intervals for inflammatory and coagulation biomarkers (HemSter Study)

IntroductionIntensive physical activity causes functional and metabolic changes in the athlete’s organism. The study aimed to verify the common national available reference intervals (RIs) for common inflammatory and screening coagulation tests in a population of healthy young female athletes.Materials and methodsOne hundred and twenty-one female athletes (age range: 16–34), from various sports disciplines (water polo, handball, volleyball, football, basketball), were included in the study. All participants completed the international physical activity short-form questionnaire. Blood samples were collected between 8–10 am, after an overnight fast, before any physical activity. Reference intervals were determined according to Clinical & Laboratory Standards Institute EP28-A3C Guidelines.ResultsCalculated RIs for white blood cell count (WBC), prothrombin time (PT), and activated partial thromboplastin time (APTT) ratio were in accordance with the common national RIs. Calculated RI for C-reactive protein (CRP) was lower (< 2.9 mg/L) than the proposed cut-off for a healthy population (< 5.0 mg/L). Reference interval for fibrinogen was higher (1.9–4.4 g/L), than the available RIs (1.8–3.5 g/L). D-dimer cut-off value was set at 852 µg/L fibrinogen equivalent units (FEU), higher than the proposed 500 µg/L FEU for venous thromboembolism (VTE) exclusion.ConclusionsThe applicability of the available RIs for WBC count, PT, and APTT-ratio was confirmed. However, RIs for CRP and fibrinogen differed significantly than the available common national RIs for the healthy non-athletes’ population. A higher cut-off for D-dimers should be extensively verified before implementation for VTE diagnosis exclusion in a group of healthy young female athletes.     

Are we using Thyroid Function Tests Appropriately?

Thyroid function tests are very important for the diagnosis and monitoring of patients with thyroid dysfunction. The guidelines recommend serum thyroid stimulating hormone (TSH) as the single most reliable test to diagnose all common forms of hypothyroidism and hyperthyroidism. The aim of this study was to analyze the ordering pattern for thyroid function tests by physicians and the analysis of results based on the clinical history. The mean age of the patients was 32.5 ± 6.5 years. Majority of samples (87.7% of total) were received from the departments of Medicine and Gynae. Thyroid profiles (47.5%) were ordered more frequently as compared to TSH only (46%). There was no significant difference in the percentage of normal reports for both types of tests. 77.8% of TFT and 76.6% of TSH samples had results within the reference range. The percentage of abnormal results was 13.7% in the patients who were screened for thyroid disorders. There is a need to redefine the case definition for thyroid dysfunction and order the appropriate test in a rational and cost effective manner.