Policies and practices in the field of laboratory hematology in Croatia - a current overview and call for improvement.

OBJECTIVES: In 2019 The Croatian Working Group for Laboratory Hematology, on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine, wanted to explore the background in field of laboratory hematology routine practice among Croatian laboratories in order to develop future strategies for producing national recommendations, if needed. METHODS: During April and May 2019, a comprehensive survey covering all main parts of the total testing process within the field of laboratory hematology among Croatian medical laboratories was conducted. The survey comprised 49 inquiries. Data was collected using Survey Monkey (Palo Alto, CA, USA). All collected data was anonymized. RESULTS: The response rate was 72%. There is still a substantial number of laboratories that have only three-part differential hematology analyzers (9%). Furthermore, a very high number of laboratories did not perform analyzer verification prior to implementation into routine work (31%). Out of those who have verified their analyzers, a diversity of guidelines and recommendations were used. Nearly 10% of the laboratories do not have a defined policy regarding specimen rejection. The majority of the participants perform internal quality control daily (83%), however, only 51% of respondents evaluate the agreement between different hematology analyzers on daily basis. Although more than 90% of Croatian laboratories have a defined policy regarding specimen rejection, only 61% of respondents continuously monitor quality indicators in routine practice. CONCLUSIONS: The survey revealed substantial differences in all aspects of laboratory hematology practices among Croatian medical laboratories, indicating the need for universal recommendations at the national level.

Thoughts and expectations of young professionals about the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM).

Objectives: Young laboratory medicine professionals (YLMPs) are the future of clinical laboratories. Although everyday practice shows significant differences among countries, especially during residency training, most of them face the same challenges. Besides promoting scientific, professional and clinical aspects of laboratory medicine in Europe, the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) should take into consideration YLMPs' concerns and interests to help them achieve excellence. The aim of this survey was to assess the opinion and expectations of YLMPs about their involvement in the activities of EFLM. Methods: An online survey was distributed to YLMPs in Europe through different channels. The questionnaire consisted of 21 items grouped into five sections: demographic questions, opinion about the current status of YLMPs within EFLM, YLMPs network, suggestions and opportunities, and scientific training and exchange. Where appropriate, responses from residents and specialists were compared. Results: A total of 329 valid responses were obtained from 53 different countries. Countries with the highest number of participants were Spain, Turkey, Croatia and Romania. A significant percentage would like to know more about EFLM and their activities (86%) and wish EFLM promoted networking and scientific exchanges (95%), for instance by means of a European YLMPs network (93%). EFLMLabX project was widely unknown (75%). Conclusions: YLMPs demand better connection to share concerns about daily healthcare duties, to keep updated and to advance professionally. EFLM needs to improve their advertising through national societies to increase YLMPs' participation. In addition to international meetings and congresses, respondents have emphasized that workshops and other small group activities would significantly help promote laboratory medicine practice in Europe.

Verification of technical characteristics and performance of VeinViewer Flex, ICEN IN-G090-2 and AccuVein AV400 transillumination devices.

BACKGROUND AND AIM: Transilluminator device allow healthcare professionals to visualize peripheral veins without using tourniquet. Aim of the study was to test the ability of three devices (Christie VeinViewer Flex (Christie, Lake Mary, Florida, USA), ICEN IN-G090-2 (ICEN Technology Company Limited, Guangdong, China) and AccuVein AV400 (AccuVein, New York, USA)) to present quality images thought defined criterion. MATERIALS AND METHODS: Study was designed as a comparison of technical characteristics, evaluation of image quality and assessment of applicability in different conditions (different viewing angels, conditions of lightning and image visibility under interference of humidity and body lotions) in reference person on two venipuncture sites. RESULTS: Devices have different technical characteristics and vary in optimal distance for good quality image (18-30 cm), number of presented veins (1-4), image dimension (6.0-90.3 cm2), length (1.5-8.0 cm) and thickness (2-5 mm) of the dominant blood vessel. Devices present different image visibility under different viewing angels, conditions of lightning and interference of humidity and body lotions (from good quality to unusable images). CONCLUSION: Transillumination devices differ in their technical characteristics and performance. The choice of the device should be based on the needs of the particular patient population and the intended use of the device.

Critical Results Reporting in Portuguese Hospital Laboratories: State-of-the-Art.

INTRODUCTION: This survey aimed to assess the state-of-the-art of current practices on critical results reporting among Portuguese Clinical Pathology Laboratories. The results of the survey will set basis for future standardization and national guideline development. MATERIALS AND METHODS: The survey was transmitted to 49 Clinical Pathology Laboratories among public hospitals inserted in the Portuguese National Health System. In 27 questions, laboratories were asked about their critical results procedures, critical results list, reporting and further education. Data were analyzed using Microsoft Excel v.2016 and MedCalc Statistical Software version 12.5.0.0 (Ostend, Belgium). Where applicable, the comparison of proportions was used to estimate the level of significance (P<0.05). RESULTS: The response rate was 44/49 (90%), including 36 participants with a defined critical results reporting procedure. Among them, 31 laboratories defined a critical results list, mainly based on published literature (27/31). There was a statistically significant number of laboratories (P=0.019, 24/30) that report different critical results depending on the patient's age, but regardless of disease, ethnicity and location (P>0.05). The majority of laboratories (60%) report critical results via telephone within 15 minutes. Critical results are usually reported by clinical pathologists to physicians. Twenty-five laboratories periodically reevaluate their critical results list. CONCLUSION: Despite the fact that most of the Portuguese hospitals have a critical results policy, this survey showed high variability among the hospitals concerning critical results reporting practices and critical results list. This survey points out that nationally established procedures and guidelines are urgent step for critical results standardization.

Third-party verification of total and specific immunoglobulin E on analyzer Immulite® 2000XPi.

BACKGROUND: Although Immulite®2000XPi (Siemens) allergy testing is routinely used in laboratories worldwide; a well-designed comprehensive third-party verification of its analytical performance has not yet been published. Our aim was to verify stability, precision and reference intervals for total and some frequent specific IgEs, test trueness for several most common allergens and assess the comparability of fluorescent- and chemiluminescent-enzyme immunoassay for total IgE. METHODS: Verification was based on EP15-A3, EP9-A3 and EP28-A3c CLSI guidelines. Stability was tested on serum pools stored at 2-8 °C, during 7 days. Manufacturer's reference intervals were verified for children and adults. Acceptance criteria were based on manufacturer specifications and national External Quality Assessment provider data. RESULTS: Samples for total IgE analysis were stable at 2-8 °C for 7 days. Precision was within manufacturer's specifications for most of tested allergens, except for total IgE (92.5 kIU/L, CVs 5.6% and 7.6%) and w1 (9.3 kU/L, CV = 5.9%). Bland-Altman plot revealed statistically significant constant (-32.4 kIU/L) and proportional bias (-20.2%) for total IgE between two methods. Passing Bablok showed statistically but not clinically significant biases between two Immulite analyzers for betula verrucosa (constant and proportional), house dust mite and egg white allergens (proportional). For adults and children, total IgE results were within reference intervals declared by Siemens. CONCLUSIONS: Immulite®2000XPi assay has acceptable precision and trueness. Samples for total IgE are stable even longer than declared by the manufacturer. Declared reference intervals can safely be adopted for both adult and children population in our laboratory. Fluorescent- and chemiluminescent-enzyme immunoassay results of total IgE are not comparable.

Clinician's opinion about critical risk results proposed by the Croatian Chamber of Medical Biochemists: a survey in one Croatian tertiary hospital.

INTRODUCTION: It has been recommended that each laboratory modify their critical result reporting practices to reflect the clinical needs of their patient populations. The aim of this survey was to assess how well critical laboratory values defined by the Croatian Chamber of Medical Biochemists (CCMB) correspond to the needs of the physicians at University hospital "Sveti Duh" (Zagreb, Croatia). MATERIALS AND METHODS: We conducted a survey among physicians from five departments in our hospital. Physicians were asked general questions about critical risk results (if and how they want to be informed). A list of critical risk results defined by the CCMB was offered and physicians were asked to revise the existing critical risk results and suggest adding new parameters. Obtained data were presented as numbers. Where the number of observations was low, ratios were used. RESULTS: Survey response rate was 43% (52/121). Majority (48/52) wants to be informed of critical risk results, either personally (31/48) or through a colleague (32/48). They prefer to be informed about critical risk results of prothrombin time, platelet count, haemoglobin, glucose, creatinine, sodium and potassium. Revisions in the CCMB critical risk result list are proposed by 13 out of 48 physicians. Neonatologists approved the CCMB's list. CONCLUSIONS: Although most critical risk results defined by the CCMB correspond well to the needs of the physicians in our hospital, some revisions are necessary to meet the particular needs of individual departments. Communication of critical risk results to those who have requested laboratory testing is highly appreciated practice.

Analytical verification of 12 most commonly used urine dipsticks in Croatia: comparability, repeatability and accuracy.

INTRODUCTION: Variability among manufacturers of urine dipsticks, respective to their accuracy and measurement range, may lead to diagnostic errors and thus create a serious risk for the patient. Our aims were to determine the level of agreement between 12 most commonly used urine dipsticks in Croatia, examine their accuracy for glucose and total protein and to test their repeatability. MATERIALS AND METHODS: A total of 75 urine samples were used to examine comparability and accuracy of 12 dipstick brands (Combur 10 TestM, ChoiceLine 10, Combur 10 TestUX, ComboStik 10M, ComboStik 11M, CombiScreen 11SYS, CombiScreen 10SL, Combina 13, Combina 11S, Combina 10M, UriGnost 11, Multistix 10SG). Agreement between each dipstick and the reference (Combur 10 TestM) was expressed as kappa coefficient (acceptable κ ≥ 0.80). Accuracy for glucose and total protein was tested by comparison with quantitative measurements on analysers: AU400 (Beckman Coulter, USA), Cobas 6000 c501 (Roche Diagnostics, Germany) and Architect plus c4000 (Abbott, USA). Repeatability was assessed on 20 replicates (acceptable > 90%). RESULTS: Best agreement was achieved for glucose, total protein and nitrite (11/11, k > 0.80) and the lowest for bilirubin (5/5, k < 0.60). Sensitivities for total protein were 41-75% (AU400) and 56-92% (Cobas and Architect); while specificities were 41-75% (AU400, Cobas, Architect). Dipsticks' sensitivity and specificity for glucose were 68-98%. Most of the dipsticks showed unacceptable repeatability (6/12, < 90%) for one parameter, most prominently for pH (3/12, < 90%). CONCLUSIONS: Most commonly used dipsticks in Croatia showed low level of agreement between each other. Moreover, their repeatability varies among manufacturers and their accuracy for glucose and proteins is poor.

Reporting categories in urine test strip analysis: Croatian survey and call for action.

INTRODUCTION: In line with the national recommendations, Croatian medical laboratories report urine test strip qualitative analysis results using a categorized scale with defined number of categories. Since concentration ranges for measured analytes have not been provided by national professional authority, it is up to the laboratories to define their own categories. The aim of study was to assess the comparability of concentrations assigned to different categories used in reporting the results of dipstick urinalysis in Croatian laboratories. MATERIAL AND METHODS: A questionnaire was e-mailed to all Croatian medical laboratories (N = 195). They were asked to provide the number of categories and respective concentrations for each parameter. Data were described as numbers and percentages. Values above the upper reference range limit, which were assigned as normal and/or trace category, were considered as false negative. RESULTS: Response rate was 71% (139/195). Seventy percent (98/139) of laboratories report their results with either higher (77/98; 79%) or lower (2/98; 2%) number of categories, relative to the national recommendation, whereas 19/98 (19%) report their results as concentrations. Great heterogeneity of reporting categories was observed. Multiple categories were assigned to same concentrations and there was a large overlap of concentrations for most categories. Considerable proportion of laboratories reported false negative results for ketones (42%), leukocytes (30%) and glucose (21%). CONCLUSIONS: The concentrations assigned to categories used to report the results of dipstick urinalysis are not comparable among Croatian medical laboratories. There is an urgent need for harmonization and standardization of reporting the results of urine dipstick analysis in Croatia.