Uloga laboratorijskih inicijativa u racionalizaciji korištenja laboratorijskih pretraga

Laboratorijski stručnjaci mogu i moraju preuzeti inicijativu u procesima racionalizacije korištenja laboratorijskih pretraga. Zbog uvođenja novih rutinskih i visokodiferentnih pretraga te zbog razvoja kliničke medicine i laboratorijske tehnologije godišnji broj pretraga u laboratorijima nezaustavljivo raste. Osim pouzdanih i točnih nalaza, laboratorij postaje suodgovoran za smisleno naručivanje i korištenje laboratorijskih usluga. U ovom radu prikazani su rezultati dosad provedenih inicijativa u Kliničkom zavodu za laboratorijsku dijagnostiku KBC-a Zagreb čiji je cilj bio smanjiti naručivanje neodgovarajućih i/ili nepotrebnih laboratorijskih pretraga. Specifično, opisane su promjene uvedene u elektronički sustav naručivanja, uvođenje funkcionalnosti minimalnih retestnih intervala te postupnici za refleksno testiranje i promjene u analitičkim metodama

Uloga laboratorijskih inicijativa u racionalizaciji korištenja laboratorijskih pretraga

Laboratorijski stručnjaci mogu i moraju preuzeti inicijativu u procesima racionalizacije korištenja laboratorijskih pretraga. Zbog uvođenja novih rutinskih i visokodiferentnih pretraga te zbog razvoja kliničke medicine i laboratorijske tehnologije godišnji broj pretraga u laboratorijima nezaustavljivo raste. Osim pouzdanih i točnih nalaza, laboratorij postaje suodgovoran za smisleno naručivanje i korištenje laboratorijskih usluga. U ovom radu prikazani su rezultati dosad provedenih inicijativa u Kliničkom zavodu za laboratorijsku dijagnostiku KBC-a Zagreb čiji je cilj bio smanjiti naručivanje neodgovarajućih i/ili nepotrebnih laboratorijskih pretraga. Specifično, opisane su promjene uvedene u elektronički sustav naručivanja, uvođenje funkcionalnosti minimalnih retestnih intervala te postupnici za refleksno testiranje i promjene u analitičkim metodama

Effectiveness of minimum retesting intervals in managing repetitive laboratory testing: experience from a Croatian university hospital

Introduction: Inappropriate laboratory retesting can be addressed by implementing minimum retesting intervals (MRI). The aim of our study was to assess the effectiveness of the implemented MRI protocol for inpatients. Materials and methods: Minimum retesting intervals were applied for 53 laboratory tests. The overall reduction of test requests, reduction in charges and reagent cost savings, frequency of MRI alert appearance as well as the rate of MRI acceptance and ignorance were calculated for a one-year period. Reasons for violating the MRI rule, hospital departments that contributed mostly to MRI rule violation, and the frequency of MRI violations between routine and emergency laboratory were evaluated. Results: During the one-year period, 106,780 requests violated the MRI rule, which corresponds to 14.8% of all requests received. 13,843 requests were cancelled, yielding a 1.9% reduction of requested tests. High-volume tests, namely complete blood count, C-reactive protein, alanine aminotransferase, gamma-glutamyltransferase and total bilirubin, accounted for 65% of all generated alerts and had the highest alert ignorance (>85%). The highest cancellation rate was observed for tumor markers and autoimmunity tests, for most being at least 50%. Annual charge reduction was 62,641 EUR while reagent cost savings were 11,408 EUR. Tests performed in the emergency laboratory had a higher alert appearance than the same routine tests. The most common reason for MRI violation was clinical justification based on the patient’s condition. Most frequently ignored MRI alerts were in the intensive care unit. Conclusion: MRI implementation showed limited effectiveness in reducing testing repetition and achieving financial savings, yet provided the basis for future improvements

The missing slope: paradoxical shortening of activated partial thromboplastin time in a patient on unfractionated heparin therapy

This case report describes false shortening of activated partial thromboplastin time (aPTT) due to erroneous optical reading of the clotting point in the presence of unfractionated heparin (UFH), and a biphasic waveform. Activated partial thromboplastin time performed on a coagulometer with photo-optical detection yielded an ambiguous clotting curve characterized by an early and steady decrease in light transmittance throughout the whole measuring range, with the clotting point read at 65 seconds. Further investigations included measurement of aPTT by means of a mechanical clot detection method as well as determination of another heparin-sensitive coagulation assay, that is thrombin time (TT), both being unmeasurably prolonged (> 150 seconds). Communication with clinicians revealed that the patient was on continuous UFH therapy and had an underlying sepsis, with highly elevated C-reactive protein (289 mg/L). The aPTT measurements requested at three timepoints later during the same day revealed gradual aPTT shortening and unveiled a peculiar biphasic waveform pattern. In this case, unmeasurably prolonged aPTT due to UFH therapy was masked by a biphasic aPTT curve pattern making only the first slope of the biphasic waveform visible within the measuring range. The early decrease in plasma light transmittance mimicked optical changes related to clot formation, thus causing erroneous optical reading and yielding a falsely shortened aPTT. This case emphasizes that such a pattern should be carefully inspected, especially when a combination of a critically ill condition and UFH therapy is present, in order to prevent erroneous reporting of aPTT and potential adverse effects on patient care

Point of care testing in Croatia: a survey of the Working group for point of care testing of the Croatian society of medical biochemistry and laboratory medicine

Graphical abstract Highlights Majority of participants find point of care testing a valuable tool that can enhance patient care Communication between laboratory and clinical personnel should be improved National point of care testing regulations are available but not implemented Education and training are crucial in ensuring high-quality results and patient safety IntroductionThe aim of this study was to investigate attitudes and routine procedures in point of care testing (POCT) among non-laboratory and laboratory healthcare professionals in Croatia. Materials and methodsThe Working Group (WG) for POCT of the Croatian society of medical biochemistry and laboratory medicine has designed two anonymous surveys for laboratory staff and non-laboratory staff with a total of 44 questions/statements on POCT (27 questions for non-laboratory staff and 17 for laboratory staff). Surveys were sent to 184 medical biochemistry laboratory (MBL) managers, the Croatian medical chamber and the Croatian chamber of nurses. The survey was disseminated using the online survey platform SurveyMonkey. ResultsA total of 112 non-laboratory healthcare professionals and 50 laboratories participated in the survey, which represents a response rate of 0.25% for non-laboratory professionals and 27% for MBLs. The majority of non-laboratory staff stated that POCT enables better medical care for the patient (90/112) and that the implementation of new POCT devices should be the responsibility of a POCT team comprising laboratory and clinical healthcare professionals. The great majority of responding MBLs (42/50) acknowledge that POCT is necessary for better patient care, and also realize that validation of POCT devices and comparison to the central laboratory is necessary before implementation (49/50). ConclusionsThe majority of participants consider POCT as a medical tool that enables better patient care but there is still a lack of communication between laboratory and clinical staff. The study identified some critical spots that will help to create national guidelines to ensure high patient safety when using POCT devices

Verification of automated latex-enhanced particle immunoturbidimetric D-Dimer assays on different analytical platforms and comparability of test results

Introduction: The aim of the study was the analytical verification of automated latex-enhanced particle immunoturbidimetric (LPIA) D-Dimer assay INNOVANCE D-dimer on Sysmex CS-5100 and Atellica COAG 360 analysers, and HemosIL D-dimer HS500 on ACL TOP 550, as well as the comparison with the enzyme-linked immunofluorescent assay (ELFA) on the miniVidas analyser. Materials and methods: Verification included assessment of within-run and between-run precision, bias, measurement uncertainty (MU), verification of the cut-off, method comparison between all assessed assays, and the reference commercial ELFA VIDAS D-Dimer Exclusion II. Results: Within-run coefficients of variations (CVs) ranged from 1.6% (Atellica COAG 360) to 7.9% (ACL TOP 550), while between-run CVs ranged from 1.7% (Sysmex CS-5100) to 6.9% (Atellica COAG 360). Spearman’s rank correlation coefficients were > 0.99 between LPIAs and ≥ 0.93 when comparing ELFA with LPIA. Passing-Bablok regression analysis yielded constant and proportional difference for comparison of ACL TOP 550 with both Sysmex CS-5100 and Atellica COAG360, and for miniVidas with Atellica COAG360. Small proportional difference was found between miniVidas and both Sysmex CS-5100 and ACL TOP 550. Calculated MUs using D-dimer HS 500 calibrator were 12.6% (Sysmex CS-5100) and 15.6% (Atellica COAG 360), while with INNOVANCE D-dimer calibrator 12.0% (Sysmex CS-5100), 10.0% (Atellica COAG 360) and 28.1% (ACL TOP 550). Excellent agreement of results was obtained, with occasional discrepancies near the cut-off. The cut-off (0.5 mg/L FEU) was confirmed. Conclusions: The obtained results prove satisfactory analytical performance of LPIAs, their high comparability and almost equal discriminatory characteristics, suggesting them as a valid alternative to ELFA

Reevaluation of von Willebrand disease diagnosis in a Croatian paediatric cohort combining bleeding scores, phenotypic laboratory assays and next generation sequencing: a pilot study

This study reevaluated von Willebrand disease (vWD) diagnosis in a Croatian paediatric cohort by combining bleeding scores (BS), phenotypic laboratory testing, and next-generation sequencing (NGS). A total of 25 children (11 males and 14 females, median age 10 years, from 2 to 17) previously diagnosed with vWD were included. BS were calculated using an online bleeding assessment tool. Phenotypic laboratory analyses included platelet count, platelet function analyser closure times, prothrombin time, activated partial thromboplastin time, von Willebrand factor antigen (vWF:Ag), vWF gain-of-function mutant glycoprotein Ib binding activity (vWF:GPIbM), vWF collagen binding activity (vWF:CBA), factor VIII activity (FVIII:C) and multimeric analysis. Next-generation sequencing covered regions of both vWF and FVIII genes and was performed on MiSeq (Illumina, San Diego, USA). Disease-associated variants identified in 15 patients comprised 11 distinct heterozygous vWF gene variants in 13 patients and one novel FVIII gene variant (p.Glu2085Lys) in two male siblings. Four vWF variants were novel (p.Gln499Pro, p.Asp1277Tyr, p.Asp1277His, p.Lys1491Glu). Three patients without distinctive variants had vWF:GPIbM between 30 and 50%. Patients with identified vWF gene variants had statistically significant lower values of vWF:GPIbM (P = 0.002), vWF:Ag (P = 0.007), vWF:CBA (P < 0.001) and FVIII:C (P = 0.002), compared to those without. Correlations between BS and phenotypic laboratory test results were not statistically significant for either of the tests. The applied diagnostic approach confirmed the diagnosis of vWD in 13 patients and mild haemophilia A in two. Limited utility of BS in the paediatric population was evidenced

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

Effective 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. An 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. The 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. Despite 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

Uloga urogvanilina u regulaciji prijenosa iona u žlijezdama slinovnicama

Objective of work: Guanylin peptides are considered to be the only intrinsic regulators of salivary glands secretion. Therefore, the aim of this study is to determine the effects of systemic uroguanylin (UGN) of the salivary flow and ion composition as well as if those effects include activation of guanylate cyclase C (GC-C). Materials and Methods: This study was conducted on 7 months old C57Bl6NCrl (wild type, WT) and GC-C knockout (KO) mice. Salivary flow rate and ion composition were determined after pilocarpine stimulation with UGN (30 µg/animal) or saline i.p. application. The expression of mRNA for AQPs, NHEs, NBCn1, Slc26a3/a6 and CFTR were determined by qPCR in submandibular salivary glands. Results: When applied i.p., UGN decreases the pilocarpine stimulated saliva flow rate and increased concentration of Na + , H + and Cl -. In GC-C KO mice, UGN shows no effect on saliva flow rate, while the concentrations of Na + , H + and Cl -are the same in GC-C KO littermates when compared to WT mice. UGN increased expression of Slc26a6 while in GC-C KO mice Slc26a6 had a higher expression when compared to WT mice, suggesting involvement of GC-C independent signalling pathway for UGN. The difference in Slc26a6 in GC-C KO mice is not unique for salivary glands because it was found also in duodenum and kidney cortex. Conclusions: The effects of UGN via basolateral membrane of salivary glands cells have not been considered up to date. In our study, UGN, when applied i.p., decreased salivary flow rate, pH, and changed composition of other ions. Therefore, plasma UGN an hour after a meal could have physiological and pathological importance (development of cavities, inflammations or demineralisations) and inhibition of systemic UGN effects could be consider as a new approach in treatment of those conditions.Cilj rada: Gvanilinski peptidi smatraju se isključivo unutarnjim regulatorima lučenja žlijezda slinovnica. Stoga je cilj ovog istraživanja utvrditi učinke sistemskog urogvanilina (UGN) na protok sline i njen ionski sastav te uključuju li ti učinci aktivaciju gvanilat ciklaze C (GC-C). Materijali i metode: Ovo istraživanje je provedeno na 7 mjeseci starim C57Bl6NCrl (divlji tip, WT) miševima te miševima kojima nedostaje GC-C (GC-C KO). Količina stvorene sline i njen ionski sastav određeni su nakon stimulacije pilokarpinom uz primjenu UGN-a (30 µg/životinji) ili fiziološke otopine i.p.. Izražaj mRNA (glasničke RNK) za AQP-e, NHE, NBCn1, Slc26a3/a6 i CFTR određena je qPCR-om u submandibularnim žlijezdama slinovnicama. Rezultati: Kada se na UGN primijeni i.p., dolazi do smanjenja brzine protoka sline stimulirane pilokarpinom i povećava koncentracija Na + , H + i Cl -. U GC-C KO miševa, UGN nema učinak na brzinu protoka sline, dok su koncentracije Na + , H + i Cl -iste u slini GC-C KO miševa u usporedbi sa WT miševima iz istog legla. UGN je povećao izražaj Slc26a6 dok je i kod GC-C KO miševa Slc26a6 imao veći izražaj u odnosu na WT miševe, što pretpostavlja uključenost GC-C neovisnog signalnog puta za UGN. Razlika u Slc26a6 kod GC-C KO miševa nije jedinstvena za žlijezde slinovnice jer je također pronađena u duodenumu i u bubrežnoj kori. Zaključci: Učinci UGN-a preko bazolateralne membrane stanica žlijezda slinovnica do danas nisu razmatrani. U našoj studiji, UGN, kada se primijeni i.p., smanjuje brzinu protoka sline, pH i mijenja ionski sastav sline. Stoga bi UGN u plazmi sat vremena nakon obroka mogao imati fiziološku i patološku važnost (razvoj karijesa, upale ili demineralizacije), a inhibicija sistemskih učinaka UGN-a mogla bi se smatrati novim pristupom u liječenju tih stanja