Relevant laboratory parameters in patients at hospital admission between July 2020 and October 2021 due to covid-19 at the Tesãi Foundation Hospital

Background:in the fight against COVID-19, the identification of laboratory predictors in the progression of severe and fatal forms is urgently needed. Aims:to describe the alterations of laboratory parameters of patients diagnosed with COVID-19 at admission to Tesãi Foundation Hospital in Ciudad del Este-Paraguay between July 2020 to October 2021.Methods:A retrospective study using the medical charts of 103 patients admitted to the hospital due to a diagnosis of COVID-19 was carried out. Demographic, clinical, and laboratory data were collected at hospital admission. Results:53.4% of the patients were male, mean age of 62.3±15.4 years, and 43.6% were admitted due to pneumonia. According to the complete blood count, 54.3% had lymphopenia, 26% thrombocytopenia, and 27% anemia. In the liver and kidney profiles, 37.9% had elevated urea levels, 56.3% elevated GOT levels, 26% elevated GPT, and 61% GGT levels. Regarding biomarkers, 80% had elevated LDH levels, 34% elevated D-dimer levels, 100% elevated C-reactive protein, 43.7% elevated procalcitonin, and 89.3% elevated ferritin. Significant differences (p<0.05) were found according to sex for the parameters of hemoglobin, hematocrit, creatinine, and the LMR ratio. Conclusion:patients presented several alterations in hematological, renal, hepatic, and inflammatory marker parameters, which offer a general overviewof the state of health with which the patient with COVID-19 is admitted to the hospital.

Introducción: en la lucha contra el COVID-19 es urgente la identificación de predictores de laboratorio en la progresión de formas graves y fatales. Objetivo:describir las alteraciones de los parámetros de laboratorio de pacientes con COVID 19 ingresados al Hospital Fundación Tesãi de Ciudad del Este-Paraguay en el período de julio de 2020 a octubre de 2021. Métodos:estudio retrospectivo, utilizando los registros de 103 pacientes ingresados al hospital por diagnóstico de COVID 19. Se recolectaron datos demográficos, clínicos y de laboratorio al ingreso hospitalario. Resultados:el 53,4% de los pacientes era del sexo masculino, edad media de 62,3±15,4 años y el 43,6% ingresó por neumonía. El 54,3% presentaba linfopenia, el 26% trombocitopenia y el 27% anemia. En el perfil hepático y renal, el 37,9% tenían niveles elevados de urea, el 56,3% niveles elevados de GOT, 26% y 61% niveles elevados de GPT y GGT, respectivamente. En cuanto a los biomarcadores, el 80 % tenía niveles elevados de LDH, el 34 % niveles elevados de dímero D, el 100 % proteína C reactiva elevada, el 43,7 % procalcitonina elevada y el 89,3 % ferritina elevada. Se encontraron diferencias significativas (p<0,05) según el sexo en los parámetros de hemoglobina, hematocrito, creatinina y el índice LMR. Conclusión:los pacientes presentaron diversas alteraciones en casi todos los parámetros evaluados, resultados que ofrecen un panorama general del estado de salud con el que ingresa el paciente con COVID 19 al hospital.

Hidden in Plain Sight: Overlooked Results and Other Errors in Evaluating Online Laboratory Results.

People are increasingly accessing their own laboratory (lab) results online. However, Canadians may be expected to use different systems to access their results, depending upon where they are tested (e.g., community lab vs. hospital), and these results may be displayed differently. This study examined the extent to which participants without medical expertise (N = 25) made errors identifying lab results (i.e., missing or mis-identifying abnormal results) in a mock report. Six participants overlooked each of the flagged values, 20 participants missed an abnormal result that was not flagged, and 2 participants mis-identified a normal value as out of range. We describe potential causes of these errors and the implications for the design of consumer-facing lab results.

FH ALERT: efficacy of a novel approach to identify patients with familial hypercholesterolemia.

Diagnosis rates of familial hypercholesterolemia (FH) remain low. We implemented FH ALERT to assess whether alerting physicians for the possibility of FH impacted additional diagnostic activity. The study was conducted from SYNLAB laboratory Weiden (Bavaria). Beyond common reporting of LDL-C or TC, 1411 physicians covering approximately a population of 1.5 million people were eligible to receive an alert letter (AL) including information on FH, if laboratory results exceeded thresholds as follows: adults LDL-C ≥ 190-250 mg/dl (to convert into mmol/l multiply with 0.0259), TC ≥ 250 to ≤ 310 mg/dl (probable suspicion); LDL-C > 250 mg/dl and TC > 310 mg/dl (strong suspicion). Persons below 18 years were alerted for LDL-C 140 mg/dl and TC ≥ 200 mg/dl (strong suspicion). Patients above 60 years were excluded. Our readouts were characteristics of involved physicians, rate of ALs issued, acceptance, and subsequent diagnostic activity. Physicians were mainly general practitioners in ambulatory care. 75% of the ordered tests were for TC, 25% for LDL-C. We issued 3512 ALs (~ 5% of tests) triggered by 2846 patients. 86% of eligible physicians stayed with the initiative, 32.7% were alerted, and 70% were positive upon call-center survey. We registered 101 new visitors of www.fhscore.eu and sent out 93 kits for genetics. Thereof, 26 were returned and 5 patients were positive for FH. Physicians were in general open to our approach. Although genetic testing was taken up with caution, this 3-months pilot examination resulted in a greater rate of patients with FH diagnosed than previous screening projects. Further education on FH in primary care is required to improve FH detection in the community.

Critical values in cytology.

The timely reporting of critical values, or values that may be life-threatening if immediate action is not taken, is essential to patient care and safety. Although some guidelines exist for critical diagnoses in cytology, not all laboratories have a specific list of diagnoses that should be considered critical, and the very existence of cytology "critical values" has been called into question. Here we propose a pragmatic system for determining cytology critical values and report our laboratory's critical value list, formulated based on a review of the medical literature regarding clinical urgency and other institutions' cytology critical value lists.

COVID-19: presentación clínica en pacientes hospitalizados en el Instituto de Medicina Tropical "Pedro Kourí" / COVID-19: clinical presentation in patients admitted to Pedro Kourí Tropical Medicine Institute

. Introducción: Con los primeros casos de COVID-19 en Cuba era necesario el reconocimiento temprano de los pacientes con riesgo de evolucionar hacia formas graves de la enfermedad. Objetivo: Describir el comportamiento clínico de la COVID-19 en pacientes hospitalizados en el Instituto de Medicina Tropical "Pedro Kourí" e identificar factores asociados a la gravedad. Métodos: Se presentaron los primeros 73 casos de COVID-19 hospitalizados en el Instituto de Medicina Tropical Pedro Kourí desde el 11 de marzo al 5 mayo de 2020. Los pacientes se clasificaron en dos grupos: graves y con enfermedad ligera. Se compararon variables clínicas, demográficas, de laboratorio e imagenológicas en el momento del ingreso, y su posible asociación con la gravedad de la enfermedad. Resultados: Hubo siete pacientes graves (9,6 por ciento), cinco fallecieron. La edad > 60 años, tener más de una comorbilidad, hipertensión arterial y asma bronquial, fueron más frecuentes en pacientes graves. La fiebre más de seis días (p= 0,00), disnea (p= 0,00), presencia de estertores húmedos (p= 0,00), frecuencia respiratoria > 24/min (p= 0,00) y valores de linfocitos < 0,8 x109/L (p= 0,00), de ferritina > 500µg/L (p =0,00), proteína C reactiva ( 10μg/L (p= 0,01) y LDH ( 500 U/L (p= 0,01) se relacionaron con la gravedad. El 18,2 por ciento de las radiografías de tórax mostró alteraciones, con predominio de focos de condensación inflamatoria bilateral. Las complicaciones más frecuentes fueron: distrés respiratorio, choque, sepsis bacteriana y afecciones cardíacas. Conclusiones: Existen características clínicas y de laboratorio, identificables al ingreso, que están relacionadas con la gravedad de la enfermedad; lo que puede ser útil para la estratificación del riesgo y el manejo adecuado de los pacientes(AU)

Introduction: Upon appearance of the first COVID-19 cases in Cuba, early identification of patients at risk of developing severe forms of the disease became a necessity. Objective: Describe the clinical behavior of COVID-19 in patients admitted to Pedro Kourí Tropical Medicine Institute and identify factors associated to severity. Methods: A presentation was made of the first 73 COVID-19 cases admitted to Pedro Kourí Tropical Medicine Institute from 11 March to 5 May 2020. The patients were divided into two groups: severe and mild disease. A comparison was made of clinical, demographic, laboratory and imaging variables at admission, and their possible association to disease severity. Results: Seven patients (9.6%) were critically ill; five died. Age > 60 years, more than one comorbidity, arterial hypertension and bronchial asthma were more common among critical patients. Fever for more than six days (p= 0.00), dyspnea (p= 0.00), presence of humid stertors (p= 0.00), respiratory rate > 24/min (p= 0.00) and lymphocytes < 0.8 x109/l (p= 0.00), ferritin > 500 µg/L (p =0.00), C-reactive protein 10 μg/l (p= 0.01) and LDH 500 U/l (p= 0.01) were related to disease severity. 18.2 percent of the chest radiographs showed alterations, with a predominance of bilateral foci of inflammatory condensation. The most common complications were respiratory distress, shock, bacterial sepsis and heart disorders. Conclusions: Some clinical and laboratory characteristics identifiable at admission may be associated to disease severity, which makes them useful for risk stratification and the appropriate management of patients(AU)

Automated Identification of Adults at Risk for In-Hospital Clinical Deterioration.

BACKGROUND: Hospitalized adults whose condition deteriorates while they are in wards (outside the intensive care unit [ICU]) have considerable morbidity and mortality. Early identification of patients at risk for clinical deterioration has relied on manually calculated scores. Outcomes after an automated detection of impending clinical deterioration have not been widely reported. METHODS: On the basis of a validated model that uses information from electronic medical records to identify hospitalized patients at high risk for clinical deterioration (which permits automated, real-time risk-score calculation), we developed an intervention program involving remote monitoring by nurses who reviewed records of patients who had been identified as being at high risk; results of this monitoring were then communicated to rapid-response teams at hospitals. We compared outcomes (including the primary outcome, mortality within 30 days after an alert) among hospitalized patients (excluding those in the ICU) whose condition reached the alert threshold at hospitals where the system was operational (intervention sites, where alerts led to a clinical response) with outcomes among patients at hospitals where the system had not yet been deployed (comparison sites, where a patient's condition would have triggered a clinical response after an alert had the system been operational). Multivariate analyses adjusted for demographic characteristics, severity of illness, and burden of coexisting conditions. RESULTS: The program was deployed in a staggered fashion at 19 hospitals between August 1, 2016, and February 28, 2019. We identified 548,838 non-ICU hospitalizations involving 326,816 patients. A total of 43,949 hospitalizations (involving 35,669 patients) involved a patient whose condition reached the alert threshold; 15,487 hospitalizations were included in the intervention cohort, and 28,462 hospitalizations in the comparison cohort. Mortality within 30 days after an alert was lower in the intervention cohort than in the comparison cohort (adjusted relative risk, 0.84, 95% confidence interval, 0.78 to 0.90; P<0.001). CONCLUSIONS: The use of an automated predictive model to identify high-risk patients for whom interventions by rapid-response teams could be implemented was associated with decreased mortality. (Funded by the Gordon and Betty Moore Foundation and others.).

Desarrollo e implementacion de un proyecto de comunicacion efectiva de valores criticos en un laboratorio publico pediatrico / Development and implementation of an effective communication project of critical values in a pediatric public laboratory / Desenvolvimento e implementação de um projeto de comunicação efetiva de valores críticos em um laboratório público pediátrico

Los valores criticos (VC) son resultados de laboratorio que deben comunicarse inmediatamente al profesional responsable, representan una amenaza para la vida del paciente y requieren atencion clinica urgente. La deteccion y comunicacion efectiva de valores criticos (CEVC) impacta directamente en la seguridad del paciente y es responsabilidad del laboratorio. Entes acreditadores y la International Organization of Standardization (ISO- 15189:2012) incluyen los VC entre sus requisitos. En 2017 se desarrollo un proyecto para garantizar la CEVC en el Hospital Garrahan. Se reviso el proceso de CEVC documentado en 2015. Se realizaron encuestas y reuniones dentro del laboratorio que evidenciaron falta de adherencia al mismo. Los VC no se comunicaban de la forma estandarizada y frecuentemente no se registraban. Se evaluaron las causas utilizando el diagrama de Ishikawa, lo que reflejo ausencia de consenso para elaborar el documento inicial. Se realizaron encuestas y reuniones intralaboratorio y con los servicios medicos, para consensuar aspectos relacionados con la CEVC y umbrales para diferentes analitos. Se acordo un nuevo listado de VC y otro de valores de informe inmediato en los que era necesario garantizar la comunicacion efectiva, aunque no requirieran intervencion medica urgente. Se protocolizo la CEVC: informe telefonico al medico tratante registrado en un formulario estandar. Se redacto y difundio un nuevo procedimiento. Se desarrollo un sistema de monitoreo con indicadores de calidad. Promover la mejora continua y desarrollar proyectos interdisciplinarios favorece la atencion centrada en el paciente y su familia. El trabajo mancomunado de diferentes servicios permitio consensuar la lista de VC y un protocolo de comunicacion acorde a las necesidades de esta institucion pediatrica.

The critical values (CV) are laboratory results that should be reported immediately to the responsible professionals, representing a threat to the patient's life and being required for urgent clinical attention. Detection and effective communication of the critical values (ECCV) impacts directly on the patient's College of Americans Pathologists (CAP), Joint Commission on Accreditation of Health Care Organizations (JCAHO), Clinical Laboratory Improvements Amendments (CLIA) e safety and it is the laboratory's responsibility. Accrediting bodies and the International Organization of Standardization (ISO 15189:2012) include CV among their mandatory requisites. In 2017, a project was developed to guarantee the ECCV at the Hospital Garrahan. The ECCV process documented in 2015 was reviewed. Surveys and assemblies were carried out within the laboratory, finding evidence of the lack of compliance with standard procedures. The CV were neither reported according to the expected standardized rules nor registered regularly. The causes were evaluated using the Ishikawa diagram, which reflected the absence of consensus to elaborate the initial document. Surveys and intra-laboratory assemblies were performed alongside with medical Departments staff, in order to come to terms on aspects related to the ECCV as well as thresholds for different analytes. Agreement was reached on a new CV list and another list for immediate reporting, in which it is essential to guarantee effective communication, even though they do not require urgent medical intervention. The ECCV was standardized through a telephone report to the treating physician registered in standard forms. A new operation procedure was edited and shared. A monitoring system with quality indicators was developed. Promoting continuous improvements as well as developing interdisciplinary projects enhance patient and family-centred care. The joint work of different Service Departments made it possible to issue the CV list and a communication protocol according to the needs of this pediatric institution.

Os valores críticos (VC) são resultados laboratoriais que devem ser imediatamente comunicados ao profissional responsável, representam uma ameaça para a vida do paciente e requerem atenção clínica urgente. A detecção e comunicação efetiva de valores críticos (CEVC) é de responsabilidade do laboratório e impacta diretamente na segurança do paciente. Organismos de acreditação e a Organização Internacional de Padronização (ISO-15189: 2012) incluem os VC entre seus requisitos. Em 2017, um projeto foi desenvolvido para garantir a CEVC no Hospital Garrahan. O processo do CEVC documentado em 2015 foi revisado. Pesquisas e reuniões foram realizadas dentro do laboratório, evidenciando a falta de adesão a ele. VC não se comunicavam de maneira padronizada e frequentemente não se registravam. As causas foram avaliadas, usando o diagrama de Ishikawa, refletindo a ausência de consenso para preparar o documento inicial. Pesquisas e reuniões foram realizadas dentro do laboratório e com os serviços médicos, para acordar aspectos relacionados à CEVC e limiares para diferentes analitos. Uma nova listagem de VC foi acordada e outra de valores de relatório imediato nas quais era necessário garantir a comunicação efetiva, mesmo que não exijissem intervenção médica urgente. O CEVC foi registrado: relatório telefônico para o médico responsável pelo tratamento registrado em um formulário padrão. Um novo procedimento foi escrito e divulgado. Um sistema de monitoramento com indicadores de qualidade foi desenvolvido. Promover a melhoria contínua e desenvolver projetos interdisciplinares favorece o cuidado centrado no paciente e sua família. O trabalho conjunto de diferentes serviços permitiu chegar a um consenso sobre a lista de VC e um protocolo de comunicação de acordo com as necessidades dessa instituição pediátrica.

Acute Kidney Injury in Children Based on Electronic Alerts.

OBJECTIVE: To define the incidence and outcome of acute kidney injury (AKI) in pediatrics using data collected from a national electronic alert system. STUDY DESIGN: A prospective national cohort study was undertaken to collect data on all cases of pediatric AKI, excluding neonates, identified by an e-alert, from April 2015 to March 2019. RESULTS: There were 2472 alerts in a total of 1719 patients, giving an incidence of 77.3 per 100 000 person-years. Of the patients, 84.2% of all AKI were stage 1 and 58.3% occurred with a triggering creatinine within the reference range. The incidence of AKI was associated with measures of social deprivation. Thirty-day mortality was 1.7% but was significantly higher in hospital-acquired AKI (2.1%), compared with community-acquired AKI (0.8%, P < .001) and was associated with the severity of AKI at presentation. A significant proportion of patients had no repeat measure of creatinine (39.8%). This was higher in community-acquired AKI (69.7%) compared with hospital-acquired AKI (43.0%, P < .001), and higher in patients alerting with patients triggering with a creatinine within the reference range (48.4% vs 24.5%, P < .001). The majority of patients (84.7%) experienced only 1 AKI episode. Repeated episodes of AKI were associated with increased 30-mortaltiy (11.6% vs 4.6%, P < .001) and higher residual renal impairment (13.3% vs 5.4%, P < .001). CONCLUSIONS: The results suggest that the significance of the alert is missed in many cases reflecting that a large proportion of cases represent modest elevations in serum creatinine (SCr), triggered by a SCr level that may be interpreted as being normal despite a significant increase from the baseline for the patient.

Communication of Critical Laboratory Values: Optimization of the Process through Secure Messaging.

BACKGROUND: Timely communication of critical laboratory results is important yet cumbersome. OBJECTIVE: To assess the impact of a new technology on the process of reporting critical laboratory results at our 480-bed, adult/children, tertiary-care, medical school-affiliated health center in the southeastern region of the United States. METHODS: We changed the process of reporting critical values by telephone only to reporting via telephone and a secure messaging app. Physician order entry, an online on-call roster for availability, and support from the C-suite (executive branch of the organization) were instrumental in implementation. RESULTS: Consistently, before our process changes, more than 95% of the critical laboratory results were reported in less than 30 minutes. Use of the app reduced the time taken for reporting results. The need to involve pathology residents and attending physicians in reporting has been eliminated by this process. DISCUSSION: Secure messaging has facilitated the reporting of critical laboratory values, making it more efficient and providing a reliable record of the process. This process meets or exceeds the standards of the accrediting agencies. The method is suitable for activating rapid-response teams in case of hypercritical values.

Diagnostic Value of Laboratory Parameters for Distinguishing Between Herpes Zoster and Bacterial Superficial Skin and Soft Tissue Infections.

Clinical differentiation between herpes zoster and bacterial superficial skin and soft tissue infections of the face can be difficult. In addition, diagnosis can be complicated by bacterial superinfection of lesional herpes zoster. The aim of this study was to determine whether inflammatory parameters, such as C-reactive protein (CRP) and blood counts, might be reliable biomarkers to distinguish between skin and soft tissue infections and herpes zoster when the face is infected. The study data (multivariate analysis and area under the curve) identified CRP (0.880) and leukocytes (0.730) together as the parameters that best discriminate between skin and soft tissue infections and herpes zoster. A CRP threshold ≥ 2.05 mg/dl indicated a diagnosis of skin and soft tissue infection with a sensitivity of 80% and specificity of 83.8%. For leukocytes ≥ 7.3×109/l, diagnosis of skin and soft tissue infection had a sensitivity of 75% and specificity of 67.6%. Thus, when differential diagnosis is difficult, CRP and leukocytes should be determined, while parameters such as neutrophils or immature granulocytes do not add diagnostic value.

Glycemic-aware metrics and oversampling techniques for predicting blood glucose levels using machine learning.

Techniques using machine learning for short term blood glucose level prediction in patients with Type 1 Diabetes are investigated. This problem is significant for the development of effective artificial pancreas technology so accurate alerts (e.g. hypoglycemia alarms) and other forecasts can be generated. It is shown that two factors must be considered when selecting the best machine learning technique for blood glucose level regression: (i) the regression model performance metrics being used to select the model, and (ii) the preprocessing techniques required to account for the imbalanced time spent by patients in different portions of the glycemic range. Using standard benchmark data, it is demonstrated that different regression model/preprocessing technique combinations exhibit different accuracies depending on the glycemic subrange under consideration. Therefore technique selection depends on the type of alert required. Specific findings are that a linear Support Vector Regression-based model, trained with normal as well as polynomial features, is best for blood glucose level forecasting in the normal and hyperglycemic ranges while a Multilayer Perceptron trained on oversampled data is ideal for predictions in the hypoglycemic range.

[Performance analysis of the Sysmex UF4000/UD10 for diagnosis of urinary tract infections]. / Analyse des performances de l'automate Sysmex UF4000 associé à l'analyseur d'images UD10 pour l'examen cytobactériologique des urines.

BACKGROUND: we evaluated the performance of the flow cytometry-based UF-4000 automated urine analyzer associated with the UD-10 image analyzer (Sysmex), in comparison with optical microscopy and culture. MATERIALS AND METHODS: 2,695 consecutive urine samples of patients were included. The cell count was performed using the analyzer and the Kova cell for 316 samples, and compared according to a threshold of 10 white blood cells (WBC) and 10 red blood cells (RBC) /µL. In a second stage, the quantitative threshold of bacteria from which a bacterial alert is triggered was chosen by comparison with the culture. Finally, the reliability (versus Gram staining and culture) of the nature of Gram negative (GN?) and Gram positive (GP?) flags has been tested on 362 samples. RESULTS: the microscopy/UF4000 discrepancy rate was 8.5% for WBC, and 16% for RBC which dropped to 6.9% after switching to UD-10. The majority of these discrepancies corresponded to quantities close to the clinical threshold, mostly higher by automatic than by microscopic counts. With a chosen warning threshold of 200 germs/µL, the «GN?¼ and «GP?¼ flags resulted in 91%/86% and 79%/20% of Gram/significant cultures of GN bacilli and GP cocci, respectively. CONCLUSION: the correlation UF4000/microscopy is satisfactory for cellularities, the UD10 allowing to correct discrepancies. The «GN?¼ flag is reliable allowing a quick diagnostic orientation for the clinician. Finally, UF4000/UD10 has shown very good performances, notably thanks to the integration of the UD-10 image analyzer, which eliminates time consuming optical microscopy cell count.

Performance of the LumiraDx Platform INR Test in an Anticoagulation Clinic Point-of-Care Setting Compared With an Established Laboratory Reference Method.

Vitamin K antagonists, such as warfarin, have a narrow therapeutic window; patients on these therapies therefore require regular international normalized ratio (INR) monitoring to maintain optimal dosing. This involves periodic checks and laboratory testing using venepuncture, which are often perceived as a burden. This study aimed to determine the accuracy and precision of the LumiraDx INR Test, a new point-of-care in vitro diagnostic platform, in an anticoagulation clinic setting. In this observational, cross-sectional study, precision of the LumiraDx INR Test was assessed using paired replicate samples (n = 366) and 3 test strip lots. Accuracy was determined by comparing capillary blood INR, ascertained by the LumiraDx INR Test, with venous plasma INR, measured by the laboratory reference instrument, the IL ACL ELITE Pro. Furthermore, INR was assessed across a range of hematocrit (25%-55%). In addition, feedback was collected from health-care professionals via a self-completed questionnaire. This trial was registered at ClinicalTrials.gov (NCT03682419). The precision (% coefficient of variation) of the LumiraDx INR Test was <4 when samples were applied by direct application or via a capillary transfer pipette, as well as between test strip lots. Accuracy of the LumiraDx INR Test, across the INR range of 0.8 to 7.5, was confirmed by a strong correlation of 0.965 (95% confidence interval: 0.959-0.970) when compared with the IL ACL ELITE Pro, which was maintained across the hematocrit range. Feedback from health-care professionals indicated that the instructions given by the system were easy to follow. In conclusion, the strong agreement between the LumiraDx Platform INR point-of-care test and the IL ACL ELITE Pro laboratory reference system, as well as between the different application methods and test lots, indicates that it can provide a rapid, accurate, and reliable INR analysis.

kEDTA Sample Contamination: A Reappraisal.

BACKGROUND: Potassium EDTA (kEDTA) contamination of serum samples is common, causing spurious hyperkalemia, hypozincemia, and hypocalcemia that if unrecognized may adversely affect patient care. Gross kEDTA contamination is easy to detect, but identification of spurious electrolytes due to small amounts of contamination requires measurement of serum EDTA. We validated an EDTA assay on the Abbott Architect and reassessed its value in identifying kEDTA contamination and in studying mechanisms for contamination. METHODS: Within- and between-batch imprecision, linearity, recovery, interference, and carryover were assessed. Serum supplemented with k2EDTA plasma, to mimic sample contamination, was used to study its effect on potassium, calcium, zinc, magnesium, and alkaline phosphatase. Our current laboratory protocol for identification of kEDTA contamination, based on measurement of serum calcium, was compared to that of EDTA measurement. RESULTS: The EDTA assay displayed acceptable performance characteristics. Hemoglobin was a positive interferent. EDTA was detectable in serum contaminated with 1% (v:v) k2EDTA plasma. An increase in serum potassium of 0.54 mmol/L (11.9%) was observed at a measured EDTA concentration of 0.19 mmol/L, equivalent to 3.2% (v:v) contamination. At this EDTA concentration reductions were also observed in zinc (71%), calcium (1%), alkaline phosphatase (ALP) (4%), and magnesium (2.4%). The serum EDTA assay detected contamination in 31/106 patient samples with hyperkalemia (potassium ≥6.0mmol/L), 20 of which were undetected by the current laboratory protocol. CONCLUSIONS: The EDTA assay displayed acceptable performance, with the ability to reliably measure EDTA at low concentrations. Only a small amount of kEDTA causes significant spurious hyperkalemia and is only reliably detected with EDTA measurement.

Hemostasis critical values among Iranian clinical laboratories "National Survey of 157 Clinical Laboratories".

BACKGROUND: Immediate reporting of critical values or test results significantly outside the normal range has a growing role in the management of patients, especially in life-threatening conditions. Due to the lack of international consensus, diverse approaches are used for determination of thresholds, reporting, documentation, and follow-up. In this study, we assessed how Iranian laboratories manage critical values for hemostasis. METHODS: We designed a standard questionnaire to assess different aspects of hemostasis critical values, including the number of coagulation tests with a defined critical value, critical values reporting, documentation, and follow-up policies. All results were self-reported and correctness of the data was not assessed by the authors. RESULTS: A total of 166 (66.4%) out of 250 laboratories completed the questionnaire; most (52.4%) were private. About 97% of responding laboratories had a critical values policy. These were defined for 64.3% (n: 27) of all coagulation tests (n: 42) performed in Iranian laboratories. Activated partial thromboplastin time (APTT), prothrombin time/international normalized ratio (PT/INR), platelet count, factor XI, and factor XIII assays had defined critical values among all laboratories performing these tests. Almost all laboratories reported critical values within 1 hour, after confirmation of the result on the same sample (70% of the laboratories) or a new one (13.4% of the laboratories). State and private laboratories had the same critical value reporting policy for in and outpatients, with laboratory technicians reporting critical results to nurses, for the most part. CONCLUSION: Although critical value policy is widely used among Iranian laboratories, there is no consensus policy for the reporting of hemostasis critical values, or documentation, threshold determination, and follow-up processes. It is impossible to determine whether non-responding laboratories had any critical values reporting policy. Results thus are biased toward laboratories that did.

Utility of Electronic Medical Record Alerts to Prevent Drug Nephrotoxicity.

Nephrotoxin-induced AKI is an iatrogenic form of AKI that can be potentially avoided or ameliorated by prompt recognition and appropriate prescriber actions. Drug-targeted alerts, either for patients at risk of AKI or patients with existing AKI, may lead to more appropriate drug dosing and management and improved clinical outcomes. However, alerts of this type are complicated to create, have a high potential for error and off-target effects, and may be difficult to evaluate. Although many studies have shown that these alerts can reduce the rate of inappropriate prescribing, few studies have examined the utility of such alerts in terms of patient benefit. In this review, we examine the current state of the literature in this area, identify key technical challenges, and suggest methods of evaluation for drug-targeted AKI alerts.

Reporting Clinical Laboratory Critical Values: A Focus On The Recommendations Of The American College Of Pathologists.

BACKGROUND: Reporting critical values continues to receive a widespread attention from health care givers as it symbolizes a crucial clinic-laboratory link. This is because healthcare providers did realize the importance of prompt and timely communication of the critical results, which have positive implications on patient safety and treatment outcomes. In addition to physician and nurses, patients are also recipients of critical values, where they can make informed decisions prior to clinical intervention. The College of American Pathologists (CAP) requires stringent policies for reporting critical values in all laboratories, including adoption of a robust quality assurance system. Research studies have indicated that there still no universally accepted critical values list. This is because of various factors; such as differences in institutional organization, patient population, clinical demand, staffing, and instrumentation. However, through collaboration with other stakeholders involved in the delivery of healthcare, lab professionals may be able to come up with a realistic critical values list that reflects on the local needs and dynamics of patients' service. CONCLUSIONS: This review offers an insight into the process of reporting critical values, some challenges encountered, as well as the policies and procedures of effective reporting with a particular focus on the guidelines of the College of American Pathologists. There should be a common global guideline introduced by the health care governing agencies to be adapted with some flexibility in clinical laboratories in different clinical settings.

Analysis of laboratory critical values at a referral Spanish tertiary university hospital.

INTRODUCTION: The aim of this study was to analyse critical value data from our laboratory and compare our critical value reporting policy with others in the literature. MATERIALS AND METHODS: Analysis of critical values was performed on data obtained over a 6-month period in a tertiary university hospital. RESULTS: We identified 5723 critical values, of which approximately 80% came from STAT testing (4577), 15% from routine inpatients testing (884) and 5% from routine outpatients testing (262). The highest proportion of critical values corresponded to oxygen partial pressure (17.7%), followed by potassium ion (17.6%) concentrations. The parameters associated with the highest critical value notification percentage in emergency patients were pH, haematocrit, glucose, potassium ion and haemoglobin concentrations. In inpatients, these parameters were glucose, phosphate, haemoglobin, sodium ion and potassium ion concentrations. In outpatients, they were calcium and potassium concentrations. CONCLUSIONS: The analysis of critical values in our hospital is in accordance with that reported in the literature. Our findings demonstrate the importance of incorporating improvement actions not only in critical value notification, but especially in the registration of this activity.

Power of the Dissolution Test in Distinguishing a Change in Dosage Form Critical Quality Attributes.

For a dissolution method to be considered relevant to in vivo performance, the dissolution data profiles should show discrimination or meaningful change when there is a change in critical material attributes (CMAs) and critical product properties (CPPs). The dissolution test has been shown repeatedly to have the power to distinguish between significant changes in active pharmaceutical ingredient (API), formulation, and process that relate to the release mechanism of the in vivo performance. Examples will be discussed in the literature where the effects of formulation, drug substance, and manufacturing variables have been measured by dissolution testing. There will be a suggested plan on how to develop and challenge a discriminating method that may be utilized for regulatory purposes. A brief review of other challenges and considerations regarding discriminatory dissolution testing is presented.