HOW ISO-15189 LABORATORY ACCREDITATION ASSURES PATIENT SAFETY? KAKO ISO-15189 AKREDITACIJA LABORATORIJA OSIGURAVA BEZBEDNOST PACIJENTA?

Summary: Healthcare is a complex profession involving the state-of-art technology and sometimes leading to unintentional harm. Many factors contribute to the occur rence of medical errors. Patient safety is one of the most serious global health issues and defined as the absence of pr eventable harm to a patient during any pr ocess of medical car e. The frequency of medical er rors is higher than expected. It has been concluded that the majority of medical er rors are not because of the individual attitudes but mainly caused by faulty systems or pr ocesses leading the staff to make mistakes or fail to pr event them. P atient safety is a shar ed responsibility comprised of many stakeholders such as society, patients, nurses, educators, administrators, r esearchers, physicians, government and legislative bodies, pr ofessional associations and accr editing agencies. Medical laborator y services are essential to patient care and need to be available to meet the needs of both patients and car egivers. ISO-1518 9:2007 Medical Laboratories-P articular requirements for quality and competence, an inter nationally recognized standard containing r equirements necessary for diagnostic laboratories to demonstrate their competence to deliver r eliable laboratory services. It applies quality system r equirements to the clinical laboratories with a str ong focus on responsiveness to the needs of patients and clinicians. Applying the per formance improvement strategies focusing on different phases in total testing pr ocess will significantly reduce the errors and therefore will improve the patient safety. In this way, laboratory professionals contribute to improvement of safety and outcomes of care by working in interdisciplinary approach manner. Keywords: patient safety, clinical laboratory, ISO 15189 Kratak sadr`aj: Zdravstvena za{tita je kompleksna profe sija koja uklju~uje najsavremeniju tehnologiju i ponekad do vodi do nenamer ne {tete. Mnogi faktori doprinose pojavi medicinskih gre{aka. Bezbednost pacijenta je je dan od naj ozbilj nijih problema globalnog zdravlja i defini sa na je kao odsustvo {tete po pacijenta koja se mo`e spr e ~iti u toku bilo kog pr ocesa medicinske nege. F rekvenca medicinskih gre {aka je ve}a od o~ekivane. Zaklju~eno je da se ve}ina me dicinskih gre{aka ne javlja zbog pojedina~nih stavova ve} je uzr ok uglavnom u nesavr{enim sistemima ili procesima koji navode osoblje da pravi gr e{ke ili da ne uspeva da ih pr e du predi. Bez bednost pacijenta je zajedni~ka odgovornost mno gih ~i ni laca kao {to su dr u{tvo, pacijenti, sestre, edukatori, admi ni stratori, istra`iva~i, leka ri, vlada i zakonodavna tela, pr o fe sio nalna udru`enja i agencije za akr editaciju. Usluge me dicinske laboratorije su esencijalne u zbrinjavanju pa cijenta i moraju da zadovolje potrebe i pacijenata i zdravstvenih radnika. ISO 15189:2007 Medicinske laboratorije -Posebni zahtevi za kvalitet i kompetentnost je me|unar odno priznati standard koji sadr`i zahteve neophodne da bi dijagnosti~ke la bo rato rije pokazale svoju kompetentnost za pr u`anje po uz danih laboratorijskih usluga. P rimenjuje zahteve sistema kva li teta na klini~ke laboratorije sa sna`nim fokusom na odgovo ru na potrebe pacijenata i klini~ara. Pri me na strategija za pobolj{anje u~inka koje se fokusiraju na razli~ite faze kompletnog pr ocesa testiranja }e zna~ajno smanjiti gre{ke i tako do pri neti bezbednosti pacijenta. Na ovaj nain, laborato rijsko osoblje doprinosi boljoj bez bednosti i ishodima zbri njavanja kroz interdisciplinarni pristup. Klju~ne re~i: bezbednost pacijenta, klini~ka laboratorija, ISO 15189 Patient safety at a glance Healthcare is highly complex pr ofession today and is of ten delivered in a pr essurized and fast-moving environment. It involves state-of-art technology but at the same time different decisions from diffe rent healthcare professionals. Sometimes, unintentional harm could occur. The problem of adverse events i

Sigma metric revisited: True known mistakes

Six Sigma methodology has been used successfully in industry since the mid-1980s. Unfortunately, the same success has not been achieved in laboratory medicine. In this case, although the multidisciplinary structure of laboratory medicine is an important factor, the concept and statistical principles of Six Sigma have not been transferred correctly from industry to laboratory medicine. Furthermore, the performance of instruments and methods used in laboratory medicine is calculated by a modified equation that produces a value lower than the actual level. This causes unnecessary, increasing pressure on manufacturers in the market. We concluded that accurate implementation of the sigma metric in laboratory medicine is essential to protect both manufacturers by calculating the actual performance level of instruments, and patients by calculating the actual error rates

The comparison of sediment count by microscopy and by automated urinary analyser

UF-100 analizoru eritrosit, lokosit, skuamoz ve transitional epitelial hticreleri, renal tubuler hticreleri, bakteri, hiyalen ve inklizyonal silendirleri, maya hticrelerini, kristalleri ve spermatozoalan argon lazer flow cytometry teknigi kullanarak ayirt eder. Biz bu cahsmada yaptigmnz mikroskopik idrar sediment analizi ile UF -100 'un sonuclanru karsilastirdik. Karstlastirmanm sonucunda lineer bir korelasyon saptandi, Eritrosit icin korelasyon katsayisi r = 0.88 iken Iokosit icin r == 0.91, epitel hiicresi icin ise r ==0.85 bulundu. Kristaller incelendiginde ise duyarlihk %71.4, ozgulluk %88.8 bulundu. Sonuc olarak UF-100 analizoru mikroskopide incelenmesi gereken numune sayisuu azaltarak, idrar analizi sonuclannm cikisuu hizlandmp is akisina kolayhk getirebilir.The UF-100 analyser identifies erythrocyte, leukocyte, squamous epithelial cells, transitional epithelial and renal tubuler cell, bacteria, hyaline and inclusional casts, yeast-like cells, crystals and spermatazoa, by using argon laser flow cytometry technique. In this study we compared UF-100 analyser with visual microscopy for sediment counts. Comparison of results obtained by visual microscopy and by the UF-100 analyser showed a linear correlation with r=0.88 for erythrocyte, r = 0.91 for leuokocytes and r = 0.85 for epithelial cells. The analyser detected crystals with a sensitivity of 71.4 % and a specificity of 88.8 0/0. In conclusion, the UF­ 100 analyser can improve the work flow, increasing the output of urinalysis by reducing the number of specimens submitted for microscopy

Indirect Reference Intervals Estimated from Hospitalized Population for Thyrotropin and Free Thyroxine

Aim To establish indirect reference intervals from patient results obtained during routine laboratory work as an alternative to laborious and expensive producing of their own reference range values according to international instructions. Methods All results for thyrotropin (TSH) and free thyroxine (T4) that were stored in our laboratory information system between 2004 and 2008 were included in this study. After a logarithmic transformation of the raw data, outliers were excluded. Non-parametric reference intervals were estimated statistically after visual observation of the distribution using stem-and-leaf plots and histograms. A standard normal deviation test was performed to test the significance of differences between sub-groups. Results There was no significant difference in serum TSH or free T4 concentrations between male and female participants. Because no differences were found within the time span of the study, combined reference intervals were calculated. Indirect reference values were 0.43-3.93 mU/L for TSH and 11.98-21.33 pmol/L for free T4. Conclusion Using patient laboratory data values is a relatively easy and cheap method of establishing laboratoryspecific reference values if skewness and kurtosis of the distribution are not too large

Biological variations of ADAMTS13 and von Willebrand factor in human adults

Background: The ultra-large von Willebrand factor (vWF) multimers are very active and must be degraded by ADAMTS13 for optimal activity. A severe functional deficiency of ADAMTS13 has been associated with thrombotic thrombocytopenic purpura. The correct interpretation of patient vWF and ADAMTS13 plasma levels requires an understanding of the biological variation associated with these analytes. In the present paper, we aimed to determine the biological variation of ADAMTS13 and vWF in human adults. Materials and methods: Blood samples were collected weekly from 19 healthy subjects for 5 consecutive weeks. vWF activity and antigenicity were determined using aggregometric and immunoturbidimetric methods. ADAMTS13 antigenicity and activity were determined by ELISA. Results: The within-subject biological variations for vWF activity and antigenicity were 8.06% and 14.37%, respectively, while the between-subject biological variations were 18.5% and 22.59%, respectively. The index of individuality for vWF activity was 0.44, while vWF antigenicity was 0.64. Similarly, ADAMTS13 activity and antigenicity within-subject biological variations were 12.73% and 9.75%, respectively, while between-subject biological variations were 9.63% and 6.28%, respectively. The ADAMTS13 indexes of individuality were 1.32 and 1.55, respectively. Conclusion: We report high biological variation and individuality in vWF antigenicity and activity levels. However, ADAMTS13 antigenicity and activity displayed high biological variation, but low individuality. Thus, population-based reference intervals may be useful for monitoring ADAMTS13 antigenicity and activity, but not for vWF, which displays high individuality. These findings should be considered when determining the reference interval and other clinical variables associated with ADAMTS13 and vWF levels

Personalized reference intervals - Statistical approaches and considerations

Under embargo until: 2022-12-13For many measurands, physicians depend on population-based reference intervals (popRI), when assessing laboratory test results. The availability of personalized reference intervals (prRI) may provide a means to improve the interpretation of laboratory test results for an individual. prRI can be calculated using estimates of biological and analytical variation and previous test results obtained in a steady-state situation. In this study, we aim to outline statistical approaches and considerations required when establishing and implementing prRI in clinical practice. Data quality assessment, including analysis for outliers and trends, is required prior to using previous test results to estimate the homeostatic set point. To calculate the prRI limits, two different statistical models based on ‘prediction intervals’ can be applied. The first model utilizes estimates of ‘within-person biological variation’ which are based on an individual’s own data. This model requires a minimum of five previous test results to generate the prRI. The second model is based on estimates of ‘within-subject biological variation’, which represents an average estimate for a population and can be found, for most measurands, in the EFLM Biological Variation Database. This model can be applied also when there are lower numbers of previous test results available. The prRI offers physicians the opportunity to improve interpretation of individuals’ test results, though studies are required to demonstrate if using prRI leads to better clinical outcomes. We recommend that both popRIs and prRIs are included in laboratory reports to aid in evaluating laboratory test results in the follow-up of patients.publishedVersio

Within- and between-subject biological variation data for serum zinc, copper and selenium obtained from 68 apparently healthy Turkish subjects

Postponed access: the file will be available after 2022-10-22Objectives: Trace elements (TrEL) are nutritionally essential components in maintaining health and preventing diseases. There is a lack of reliable biological variation (BV) data for TrELs, required for the diagnosis and monitoring of TrEL disturbances. In this study, we aimed to provide updated within- and between-subject BV estimates for zinc (Zn), copper (Cu) and selenium (Se). Methods: Weekly serum samples were drawn from 68 healthy subjects (36 females and 32 males) for 10 weeks and stored at −80 °C prior to analysis. Serum Zn, Cu and Se levels were measured using inductively-coupled plasma mass spectrometry (ICP-MS). Outlier and variance homogeneity analyses were performed followed by CV-ANOVA (Røraas method) to determine BV and analytical variation estimates with 95% CI and the associated reference change values (RCV) for all subjects, males and females. Results: Significant differences in mean concentrations between males and females were observed, with absolute and relative (%) differences for Zn at 0.5 μmol/L (3.5%), Cu 2.0 μmol/L (14.1%) and Se 0.06 μmol/L (6.0%). The within-subject BV (CVI [95% CI]) estimates were 8.8% (8.2–9.3), 7.8% (7.3–8.3) and 7.7% (7.2–8.2) for Zn, Cu and Se, respectively. Within-subject biological variation (CVI) estimates derived for male and female subgroups were similar for all three TrELs. Marked individuality was observed for Cu and Se. Conclusions: The data of this study provides updated BV estimates for serum Zn, Cu and Se derived from a stringent protocol and state of the art methodologies. Furthermore, Cu and Se display marked individuality, highlighting that population based reference limits should not be used in the monitoring of patients.publishedVersio

Exposure to Perchlorate in Lactating Women and Its Associations With Newborn Thyroid Stimulating Hormone

Background: Perchlorate, thiocyanate, and nitrate can block iodide transport at the sodium iodide symporter (NIS) and this can subsequently lead to decreased thyroid hormone production and hypothyroidism. NIS inhibitor exposure has been shown to reduce iodide uptake and thyroid hormone levels; therefore we hypothesized that maternal NIS inhibitor exposure will influence both maternal and newborn thyroid function.Methods: Spot urine samples were collected from 185 lactating mothers and evaluated for perchlorate, thiocyanate, and nitrate concentrations. Blood and colostrum samples were collected from the same participants in the first 48 h after delivery. Thyroid hormones and thyroid-related antibodies (TSH, fT3, fT4, anti-TPO, anti-Tg) were analyzed in maternal blood and perchlorate was analyzed in colostrum. Also, spot blood samples were collected from newborns (n = 185) between 48 and 72 postpartum hours for TSH measurement. Correlation analysis was performed to assess the effect of NIS inhibitors on thyroid hormone levels of lactating mothers and their newborns in their first 48 postpartum hours.Results: The medians of maternal urinary perchlorate (4.00 μg/g creatinine), maternal urinary thiocyanate (403 μg/g creatinine), and maternal urinary nitrate (49,117 μg/g creatinine) were determined. Higher concentrations of all three urinary NIS inhibitors (μg/g creatinine) at their 75th percentile levels were significantly correlated with newborn TSH (r = 0.21, p < 0.001). Median colostrum perchlorate level concentration of all 185 participants was 2.30 μg/L. Colostrum perchlorate was not significantly correlated with newborn TSH (p > 0.05); however, there was a significant correlation between colostrum perchlorate level and maternal TSH (r = 0.21, p < 0.01). Similarly, there was a significant positive association between colostrum perchlorate and maternal urinary creatinine adjusted perchlorate (r = 0.32, p < 0.001).Conclusion: NIS inhibitors are ubiquitous in lactating women in Turkey and are associated with increased TSH levels in newborns, thus signifying for the first time that co-exposure to maternal NIS inhibitors can have a negative effect on the newborn thyroid function