Introduction: The study intends to observe the frequency of preanalytical phase errors both inside and outside the clinical laboratory according to certain quality indicators (QIs). Methods: The one-week observation focused on 73 nurses drawing blood from 337 patients. It was performed in two stages: the observation of blood collection up to the receipt of the samples, and the receipt of the samples up to the analytical phase. The data pertaining to the number of patients, tests, and rejection rates were obtained from the laboratory information system (LIS) for the one-week and the one-year period and compared with the observational data. Results: The process of blood sample collection from 337 patients taken into 1347 tubes was observed. Although the majority of the nurses (78%) used safety needles, the safety mechanism was properly activated only in 38% of the interventions. Evaluation of biochemistry tubes (n=971) revealed the following: the incorrect fill volume error was 40%; the hemolysis was seen by 17%, and the clotted sample and fibrin were observed by 6%. The incorrect fill volume error was 12% and 20% in ethylenediaminetetraacetic acid (EDTA) and citrated tubes, respectively. Clotted samples and platelet clumps were seen in 1% of EDTA tubes. Conclusion: The study confirms the relative frequency of preanalytical phase error occurring inside and outside of the laboratory.

This paper reflects the opinion of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO). It aims to provide guidance for drawing up local/national documents about validation and verification of laboratory methods. We demonstrate how risk evaluation can be used to optimize laboratory policies to meet intended use requirements as well as requirements of standards. This is translated in a number of recommendations on how to introduce risk evaluation in various stages of the implementation of new methods ultimately covering the whole process cycle.

Centrifugation separates particles within the specimen according to their shape, dimensions, and density and basically can be defined as a separation method. The centrifuge is an essential device in medical laboratories to prepare the serum, plasma, and urine samples for analysis. It is basically an electric device composed of the stationary (motor) and the motile (rotor) part. The centrifugation depends on two main variables: relative centrifugal force (RCF) and centrifugation time. The physical impact separating the specimen into its components in the centrifuge known as RCF is expressed as the multiples of gravitational acceleration (×g). RPM, defined as the number of rotations of the centrifuge per minute, shows the speed of the centrifuge. RCF value can be calculated by using RPM, and the centrifuge radius. Because models and sizes of centrifuges vary considerably, the use of gravity (g) forces instead of RPM is suggested. The centrifuges can be classified according to their usage, speed, technical specifications, and rotor type. An accurate and precise centrifugation process is essential to prevent errors in the preanalytical phase. The purpose of this document is to ensure the standardization of a good, precise protocol for the centrifugation process among the medical laboratories.

ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer’s selected measurement procedure and the manufacturer’s working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibrators that they use. Although the between-lot variation in value assignment will manifest itself as part of the long-term imprecision as estimated by the end-user, information on worst-case to be expected lot-lot variation has to be communicated to the end-user by the IVD provider. When laboratories use ancillary equipment that potentially could have a critical contribution to the reported results, such equipment needs verification of its proper calibration and criticality to the result uncertainty could be assessed by an approach based on risk analysis, which is a key element of ISO15189:2012 anyway. This paper discusses how the requirement for metrological traceability as stated in ISO15189 should be met by the medical laboratory and how this should be assessed by accreditation bodies.

OBJECTIVES: The aim of our study was to investigate the effects of folic acid on cisplatin-induced ototoxicity. MATERIALS and METHODS: Thirty Wistar albino rats were divided into five groups. Group I received intraperitoneal cisplatin (IP) 10 mg/kg/day and IP folic acid 10 mg/kg/day; Group II received IP cisplatin 10 mg/kg/day and IP physiological saline; Group III received IP cisplatin 10 mg/kg/day and intratympanic (IT) folic acid 0.15 mL/day; Group IV received IP cisplatin 10 mg/kg/day and IT physiological saline; and Group V received IT folic acid 0.15 mL/day. Before and after drug administration, plasma homocysteine, folic acid levels, and auditory brainstem evoked responses (ABR) were measured. The rats were then sacrificed, and the inner ears were processed for electron microscopy. RESULTS: The differences of ABR thresholds in Group I compared to Group II were significantly smaller at 4 kHz, 8 kHz, and 16 kHz, whereas they were smaller but not statistically significant at 12 kHz in ABR. The differences of ABR thresholds in Group III compared to Group IV were significantly smaller at 12 kHz, and smaller but not statistically significant at 4 kHz, 8 kHz, and 16 kHz. Cisplatin treatment resulted in the degeneration of the cells of the organ of Corti, stria vascularis, and spiral ganglion. The cells of the organ of Corti, stria vascularis, and spiral ganglion showed a partially preserved morphology in both Group I and Group III. CONCLUSION: Our study results suggests that folic acid is a potential agent in preventing cisplatin-induced ototoxicity. Cite this article as: Tanyeli TT, Karadaş H, Akyıldız İ, Gökdoğan O, Sönmez Ç, Çavuş ME, et al. Effect of Folic Acid on Cisplatin-Induced Ototoxicity: A Functional and Morphological Study. J Int Adv Otol 2019; 15(2): 237-46.