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.

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.

External quality assessment of medical laboratories in Croatia: preliminary evaluation of post-analytical laboratory testing.

INTRODUCTION: Proper standardization of laboratory testing requires assessment of performance after the tests are performed, known as the post-analytical phase. A nationwide external quality assessment (EQA) scheme implemented in Croatia in 2014 includes a questionnaire on post-analytical practices, and the present study examined laboratory responses in order to identify current post-analytical phase practices and identify areas for improvement. MATERIALS AND METHODS: In four EQA exercises between September 2014 and December 2015, 145-174 medical laboratories across Croatia were surveyed using the Module 11 questionnaire on the post-analytical phase of testing. Based on their responses, the laboratories were evaluated on four quality indicators: turnaround time (TAT), critical values, interpretative comments and procedures in the event of abnormal results. Results were presented as absolute numbers and percentages. RESULTS: Just over half of laboratories (56.3%) monitored TAT. Laboratories varied substantially in how they dealt with critical values. Most laboratories (65-97%) issued interpretative comments with test results. One third of medical laboratories (30.6-33.3%) issued abnormal test results without confirming them in additional testing. CONCLUSION: Our results suggest that the nationwide post-analytical EQA scheme launched in 2014 in Croatia has yet to be implemented to the full. To close the gaps between existing recommendations and laboratory practice, laboratory professionals should focus on ensuring that TAT is monitored and lists of critical values are established within laboratories. Professional bodies/institutions should focus on clarify and harmonized rules to standardized practices and applied for adding interpretative comments to laboratory test results and for dealing with abnormal test results.

Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine.

Capillary blood sampling is a medical procedure aimed at assisting in patient diagnosis, management and treatment, and is increasingly used worldwide, in part because of the increasing availability of point-of-care testing. It is also frequently used to obtain small blood volumes for laboratory testing because it minimizes pain. The capillary blood sampling procedure can influence the quality of the sample as well as the accuracy of test results, highlighting the need for immediate, widespread standardization. A recent nationwide survey of policies and practices related to capillary blood sampling in medical laboratories in Croatia has shown that capillary sampling procedures are not standardized and that only a small proportion of Croatian laboratories comply with guidelines from the Clinical Laboratory Standards Institute (CLSI) or the World Health Organization (WHO). The aim of this document is to provide recommendations for capillary blood sampling. This document has been produced by the Working Group for Capillary Blood Sampling within the Croatian Society of Medical Biochemistry and Laboratory Medicine. Our recommendations are based on existing available standards and recommendations (WHO Best Practices in Phlebotomy, CLSI GP42-A6 and CLSI C46-A2), which have been modified based on local logistical, cultural, legal and regulatory requirements. We hope that these recommendations will be a useful contribution to the standardization of capillary blood sampling in Croatia.