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.

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)

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.

Semiautomated System for Nonurgent, Clinically Significant Pathology Results.

BACKGROUND: Failure of timely test result follow-up has consequences including delayed diagnosis and treatment, added costs, and potential patient harm. Closed-loop communication is key to ensure clinically significant test results (CSTRs) are acknowledged and acted upon appropriately. A previous implementation of the Alert Notification of Critical Results (ANCR) system to facilitate closed-loop communication of imaging CSTRs yielded improved communication of critical radiology results and enhanced adherence to institutional CSTR policies. OBJECTIVE: This article extends the ANCR application to pathology and evaluates its impact on closed-loop communication of new malignancies, a common and important type of pathology CSTR. MATERIALS AND METHODS: This Institutional Review Board-approved study was performed at a 150-bed community, academically affiliated hospital. ANCR was adapted for pathology CSTRs. Natural language processing was used on 30,774 pathology reports 13 months pre- and 13 months postintervention, identifying 5,595 reports with malignancies. Electronic health records were reviewed for documented acknowledgment for a random sample of reports. Percent of reports with documented acknowledgment within 15 days assessed institutional policy adherence. Time to acknowledgment was compared pre- versus postintervention and postintervention with and without ANCR alerts. Pathologists were surveyed regarding ANCR use and satisfaction. RESULTS: Acknowledgment within 15 days was documented for 98 of 107 (91.6%) pre- and 89 of 103 (86.4%) postintervention reports (p = 0.2294). Median time to acknowledgment was 7 days (interquartile range [IQR], 3, 11) preintervention and 6 days (IQR, 2, 10) postintervention (p = 0.5083). Postintervention, median time to acknowledgment was 2 days (IQR, 1, 6) for reports with ANCR alerts versus 6 days (IQR, 2.75, 9) for reports without alerts (p = 0.0351). ANCR alerts were sent on 15 of 103 (15%) postintervention reports. All pathologists reported that the ANCR system positively impacted their workflow; 75% (three-fourths) felt that the ANCR system improved efficiency of communicating CSTRs. CONCLUSION: ANCR expansion to facilitate closed-loop communication of pathology CSTRs was favorably perceived and associated with significant improved time to documented acknowledgment for new malignancies. The rate of adherence to institutional policy did not improve.

The anteroposterior diameter of nodules in the risk assessment of papillary thyroid microcarcinoma.

This study investigates the application of ultrasound, especially the anteroposterior diameter of nodules in the malignancy and metastasis risk assessment of papillary thyroid microcarcinoma through a retrospective analysis of 500 cases of thyroid nodule ultrasonography.We selected 500 patients with thyroid nodules (maximum nodule diameter ≤2.0 cm) that had been diagnosed clinically and graded TI-RADS 4c by ultrasonography and surgically treated. Among these, there were 258 cases of pathologically diagnosed papillary thyroid microcarcinoma, 72 cases of nodular goiter or adenoma, 137 cases of papillary thyroid carcinoma, 28 cases of acinar cell carcinoma, and 5 cases of undifferentiated carcinoma. In all cases, color Doppler ultrasonography had been performed preoperatively to determine the size and number of nodules, surrounding lymph node metastasis, and TI-RADS grading. Cases of papillary thyroid microcarcinoma diagnosed by pathology were selected as the study group, and cases of nodular goiter or adenoma as the control group. Each group was further subdivided based on the anteroposterior, vertical, and transverse nodule diameters. Intergroup statistical analysis was also performed. Receiver operating characteristic (ROC) curve analysis was conducted on the study and control groups based on the anteroposterior nodule diameters, and the optimal critical value for malignancy risk was determined. Thyroid nodules in the study group were divided into groups based on the presence or absence of lymph node metastasis. Based on the anteroposterior nodule diameter, ROC curve analysis was performed, and the optimal critical value for metastasis risk was determined.There were 500 cases of malignant nodules diagnosed by ultrasound. Among these, there were 428 cases of malignant nodules diagnosed by pathology. The coincidence rate of the ultrasound diagnosis with pathological diagnosis was 85.60%. While, interestingly, There was a significant statistical difference between the study and control groups based on the anteroposterior nodule diameter. When the anteroposterior nodule diameter was 0.7 cm, sensitivity of malignant diagnosis was 76.70% and specificity of that was 66.70%, and the Youden index was the highest. The lymph node metastasis rate for papillary thyroid microcarcinoma was 13.95%. Within this group, the lymph node metastasis rate for nodules ≥0.9 cm (anteroposterior diameter) was 38.46%. When the anteroposterior nodule diameter was equal to 0.9 cm, sensitivity of diagnosis was 83.30%, and specificity of that was 77.80%, and the Youden index was the highest.The anteroposterior diameter of thyroid nodules is more suitable for assessing their malignancy with 0.7 cm, which can be used as the critical value. Nodules ≥ 0.7 cm require surgical treatment, and those <0.7 cm can be observed. An anteroposterior diameter of 0.9 cm can be used as the critical value for assessing the metastasis risk of malignant thyroid nodules. During surgery, the dissection of central cervical lymph nodes is required for nodules ≥0.9 cm.

New Alert Message Settings for the XN-series Automated Hematology Analyzer Are Useful for Avoiding Falsely High WBC Counts and to Detect Specimens with Giant Platelets.

We encountered blood specimens from a patient with MYH9 related diseases, which gave falsely high white blood cell (WBC) counts during laboratory analysis using Sysmex XN-series automated hematology analyzers. This overcount was revealed to be caused by the overlapping of platelet (PLT) distribution with the WBC area in the WNR channel, which was used for routine WBC count with the XN-series. On the other hand, the WBC count obtained through the WDF channel of the XN-series seemed more accurate in such a case. We then created and introduced alert message settings for such rare but critical specimens, which gives a warning when the discrepancy in WBC counts between the WNR and WDF channels is higher than 1.0×109/L. By using the alert message setting, we were able to detect some specimens which gave falsely high WBC counts with the routine WNR channel from three other cases of giant PLTs. In conclusion, our alert message setting seems useful in avoiding false reporting of WBC count due to abnormal cells, including giant PLTs.

Critical diagnoses in cytopathology: Experience at a large medical center.

BACKGROUND: Critical values have been well established and accepted in laboratory medicine, but to the authors' knowledge are less well accepted in anatomic pathology. Herein, the authors used a reporting process whereby reports with critical diagnoses were coded to ensure that the patient's clinical team was promptly notified electronically of this finding. The aim of the current study was to determine whether this coding mechanism was used appropriately for critical cytopathology diagnoses in the study health care system. METHODS: A retrospective review of the University of Pittsburgh Medical Center anatomic pathology laboratory information system was performed to identify cytopathology reports in which a critical diagnosis code (MedTrak notification/CoPath Tissue Code TC66; TC66) was used from 2011 through 2016. TC66-coded cytopathology reports between 2015 and 2016 were reviewed further to determine whether this code was used appropriately. RESULTS: A total of 1687 TC66-coded cytopathology reports were identified. Between 2015 and 2016, a total of 30 of 46 reports (65%) from academic hospitals and 46 of 441 reports (10%) from community hospitals met the critical diagnoses criteria outlined by institutional policy. The remaining TC66-coded cases were predominantly for new diagnoses of malignancy in patients clinically suspected of having cancer. CONCLUSIONS: Use of a code for critical cytopathology diagnoses was found to be occurring increasingly at the study health care system. Pathologists at the academic and community hospitals in the study institution used this code somewhat differently, reflecting the need to satisfy communication with clinicians in different practice settings. Nevertheless, the authors' experiences with using a code for critical diagnoses not only ensured timely patient care but also proposed a model that could be used by other medical specialties to enhance communication and improve quality of care. Cancer Cytopathol 2017;125:726-30. © 2017 American Cancer Society.

Using a linked database for epidemiology across the primary and secondary care divide: acute kidney injury.

BACKGROUND: NHS England has mandated the use in hospital laboratories of an automated early warning algorithm to create a consistent method for the detection of acute kidney injury (AKI). It generates an 'alert' based on changes in serum creatinine level to notify attending clinicians of a possible incident case of the condition, and to provide an assessment of its severity. We aimed to explore the feasibility of secondary data analysis to reproduce the algorithm outside of the hospital laboratory, and to describe the epidemiology of AKI across primary and secondary care within a region. METHODS: Using the Hampshire Health Record Analytical database, a patient-anonymised database linking primary care, secondary care and hospital laboratory data, we applied the algorithm to one year (1st January-31st December 2014) of retrospective longitudinal data. We developed database queries to modularise the collection of data from various sectors of the local health system, recreate the functions of the algorithm and undertake data cleaning. RESULTS: Of a regional population of 642,337 patients, 176,113 (27.4%) had two or more serum creatinine test results available, with testing more common amongst older age groups. We identified 5361 (or 0.8%) with incident AKI indicated by the algorithm, generating a total of 13,845 individual AKI alerts. A cross-sectional assessment of each patient's first alert found that more than two-thirds of cases originated in the community, of which nearly half did not lead to a hospital admission. CONCLUSION: It is possible to reproduce the algorithm using linked primary care, secondary care and hospital laboratory data, although data completeness, data quality and technical issues must be overcome. Linked data is essential to follow the significant proportion of people with AKI who transition from primary to secondary care, and can be used to assess clinical outcomes and the impact of interventions across the health system. This study emphasises that the development of data systems bridging across different sectors of the health and social care system can provide benefits for researchers, clinicians, healthcare providers and commissioners.

Outlier-based detection of unusual patient-management actions: An ICU study.

Medical errors remain a significant problem in healthcare. This paper investigates a data-driven outlier-based monitoring and alerting framework that uses data in the Electronic Medical Records (EMRs) repositories of past patient cases to identify any unusual clinical actions in the EMR of a current patient. Our conjecture is that these unusual clinical actions correspond to medical errors often enough to justify their detection and alerting. Our approach works by using EMR repositories to learn statistical models that relate patient states to patient-management actions. We evaluated this approach on the EMR data for 24,658 intensive care unit (ICU) patient cases. A total of 16,500 cases were used to train statistical models for ordering medications and laboratory tests given the patient state summarizing the patient's clinical history. The models were applied to a separate test set of 8158 ICU patient cases and used to generate alerts. A subset of 240 alerts generated by the models were evaluated and assessed by eighteen ICU clinicians. The overall true positive rates for the alerts (TPARs) ranged from 0.44 to 0.71. The TPAR for medication order alerts specifically ranged from 0.31 to 0.61 and for laboratory order alerts from 0.44 to 0.75. These results support outlier-based alerting as a promising new approach to data-driven clinical alerting that is generated automatically based on past EMR data.

Verificación de métodos en un laboratorio acreditado y planificación del control de calidad interno / Method verification in a certified laboratory and internal quality control planification / Verificação de métodos num laboratório credenciado e planejamento do controle de qualidade interno

En el proceso de verificación de métodos se obtienen datos del desempeño del sistema de medición en las condiciones de trabajo del laboratorio; luego esto es cotejado con las especificaciones brindadas por el fabricante de reactivos y con los requerimientos de calidad disponibles de distintas fuentes. Los objetivos del presente trabajo fueron aplicar protocolos de evaluación de métodos publicados en guías internacionales (CLSI, Clinical Laboratory Standard Institute) para verificar el correcto rendimiento de las metodologías evaluadas y diseñar e implementar una estrategia de control de calidad interno (CCI) que permita evaluar la estabilidad del sistema de medición en el tiempo. Se evaluaron glucosa, creatinina y láctico deshidrogenasa (LDH); sobre las metodologías para la valoración de los mismos se realizaron los ensayos correspondientes a la verificación de precisión y veracidad, linealidad, límite de detección, comparación de equipos y establecimiento de valores de referencia de acuerdo con lo establecido en las guías CLSI EP15-A2, EP6-A, EP17-A, EP9-A2, C28-A2, respectivamente. En todos los ensayos realizados se cumplieron con las especificaciones estipuladas por el fabricante para cada analito, como así también con los requerimientos de calidad elegidos para el error total permitido. Además, se determinó el punto operativo y se especificaron las reglas de CCI adecuadas para el seguimiento del desempeño de estas metodologías. Con los resultados obtenidos se construyó una matriz de calidad para hacer el seguimiento mensual de los parámetros evaluados. Aplicando procedimientos de verificación de métodos se demostró la aceptabilidad de los parámetros analíticos evaluados. La verificación de los métodos permite diseñar y aplicar una estrategia de CCI para evaluar la estabilidad analítica de los sistemas de medición en el tiempo, dentro de un marco de seguridad analítica exigido para métodos acreditados.

The process of method verification (MV) generates data about the performance of a measuring system in current laboratory working conditions; later, the information obtained is compared to the specifications issued by the assay manufacturer and International Regulating Organizations. The objectives of this study were: 1) to apply evaluation protocols established by international guidelines (CLSI, Clinical Laboratory Standards Institute) to verify the correct performance of the methodologies under analysis; 2) to design and implement a strategy of internal quality control (IQC) that allows evaluating the stability of the measuring system in time. Glucose, creatinine and lactate deshidrogenase were subject to analysis. Verification of precision, trueness, linearity detection limit, instrument comparison and reference values were performed under the provisions of CLSI EP-15A2, EP6A, EP17-A, EP9-A2 and C28-A2 guidelines, respectively. For every assay, the procedures indicated by the manufacturer were respected, as well as the quality requirements chosen for total allowed error. An operative point was obtained and adequate ICQ rules for monitoring the performance of those methodologies were established. With the results obtained, a quality matrix was built for a monthly follow-up of the evaluated parameters. The acceptability of the evaluated analytical parameters was proved by the application of MV procedures. Furthermore, the MV enabled to design and implementation of an ICQ strategy to test the analytical stability of the measuring systems, in the analytical safety environment required for accredited methods.

No processo de verificação de métodos são obtidos dados do desempenho do sistema de medição nas condições de trabalho do laboratório; depois isto é comparado com as especificações oferecidas pelo fabricante de reagentes de laboratório e com os requerimentos de qualidade disponíveis em diversas fontes. Os objetivos do presente trabalho foram aplicar protocolos de avaliação de métodos publicados em guias internacionais (CLSI, Clínical Laboratory Standard Institute) para verificar o correto rendimento das metodologias avaliadas e desenhar e implementar uma estratégia de controle de qualidade interno (CCI) que permita avaliar a estabilidade do sistema de medição no tempo. Foram avaliadas glicose, creatinina e desidrogenase lática (LDH); sobre as metodologias para a avaliação dos mesmos foram realizados os ensaios correspondentes à verificação de precisão e veracidade, linearidade, limite de detecção, comparação de equipamentos e estabelecimento de valores de referência conforme o estabelecido nos guias CLSI EP15-A2, EP6-A, EP17-A, EP9-A2, C28-A2, respectivamente. Em todos os ensaios realizados foram cumpridas as especificações estabelecidas pelo fabricante para cada analito, bem como com os requerimentos de qualidade selecionados para o erro total permitido. Além disso, foi possível determinar o ponto operacional e especificar as regras do CCI adequadas para o acompanhamento do desempenho destas metodologias. Com os resultados obtidos se construiu uma matriz de qualidade para fazer o acompanhamento mensal dos parâmetros avaliados. Aplicando procedimentos de verificação de métodos foi demonstrada a aceitabilidade dos parâmetros analíticos avaliados. A verificação dos métodos permite desenhar e aplicar uma estratégia de CCI para avaliar a estabilidade analítica dos sistemas de medição no tempo, dentro de um quadro de segurança analítica exigido para métodos com credenciamento.

Auditoría clínica: una herramienta para el seguimiento de errores preanalíticos en el laboratorio / Clinical audit: a tool to monitor pre-analytical errors in the laboratory

El objetivo del trabajo fue evaluar la efectividad de un programa de auditoría clínica para vigilar y reducir la magnitud de errores preanalíticos en el Laboratorio de Guardia de un hospital público de la provincia de Buenos Aires. En un período de 2004 y otro de 2005 se relevaron los diferentes tipos de errores en 11.949 recipientes de muestras de sangre y orina. Se calcularon los indicadores: porcentaje de errores preanalíticos totales en las muestras (% EP), de muestras coaguladas, de recipientes inadecuados, de volumen inadecuado, de muestras hemolizadas, de muestras batidas y de identificación inadecuada. Se capacitó al personal de enfermería. Se asignaron los costos correspondientes a las etapas de obtención y remisión de muestras de la fase preanalítica. El % EP no presentó modificaciones significativas en 2004, mientras que en 2005 sus variaciones acompañaron las de algunos de los restantes indicadores. Los costos correspondientes a errores preanalíticos constituyeron en promedio el 10% de los costos totales de obtención y remisión de muestras en los períodos estudiados. Se concluye que las actividades de capacitación deben realizarse en forma periódica y someterse a seguimiento continuo a fin de obtener disminuciones significativas y perdurables en la magnitud de los errores preanalíticos.

The aim of this study was to evaluate the effectiveness of a clinical audit program to monitor and reduce the magnitude of pre-analytical errors in the Emergency Laboratory of a Buenos Aires Province public hospital. During a 2004 period and another 2005 one, different types of errors were surveyed in 11.949 blood- and urine-sample flasks. The following indicators were calculated: sample pre-analytical error percentage (% PE), as well as percentages corresponding to coagulated samples, inadequate flask use, inadequate flask volume, samples that underwent haemolysis, shaken samples and poor sample identification. Nursing personnel were trained. Costs incurred were allocated to the extraction and delivery stages within the pre-analytical phase. PE % did not show any meaningful changes in 2004, while in 2005 its variations followed those of some of the other indicators. Costs attributed to pre-analytical error represented 10% of total cost of sample extraction and delivery in the periods that were studied. It can be concluded that training courses must be periodically offered and their results monitored on a permanent basis if any significant and long-lasting reduction in the magnitude of pre-analytical errors is to be achieved.