Characterization of add-on testing before and after automation at a core laboratory.

Objectives: Add-on testing refers to the process that occurs in clinical laboratories when clinicians request that additional tests be performed on a previously analysed specimen. This is a common but inefficient procedure, highly time-consuming, especially at core laboratories and could be optimised by automating these procedures. The aims of this study are: 1) To describe patterns of add-on testing at a core laboratory at a tertiary hospital, 2) To evaluate turnaround time (TAT) before and after automation of the pre-, post- and analytical phases. Methods: Retrospective, observational study conducted at the biochemistry area of a core laboratory of all add-on orders received in two different months (pre-automation and post-automation). Results: A total of 2464 add-on orders were analysed, representing around 5 % of total requests. Most orders were for either one (>50 %) or two (≈20 %) tests. Most orders were received during the week (from Monday to Friday), particularly during the morning shift (>50 %). More than 50 % of requests were made by the Emergency Department. The two most common add-on parameters were C-reactive protein and N-terminal pro-brain natriuretic peptide. After automation, the median TAT decreased by 42.3 % (from 52 to 22 min). The largest decreases in TAT were observed for routine samples (58.89 %) and fully automated analyses (56.86 %). Conclusions: Automation of our core laboratory substantially reduced turnaround time for add-on testing, indicating an increase in efficiency. Automation eliminated several manual steps in the process, leading to a mean reduction of 15 work hours per day (more than 2 full-time equivalents).

Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results.

The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements. The scope of this paper includes postanalytical activities and the personnel involved (laboratory management and staff). We describe the criteria and information required to review and validate analytical results and ensure that clear reports are sent to requesters. These criteria also guarantee that results are transcribed in a reliable way and that all necessary information is provided for the correct interpretation of results. Likewise, the requirements for the correct release of laboratory results are described, with special emphasis on the release of alarming or critical results. In some European countries, clinical laboratories are required to hold partial or full ISO 15189 accreditation, which is a global trend. Therefore, understanding ISO 15189 requirements is imperative for a progressive and more effective implementation of the Standard.

Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management.

ISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in reports issued by accredited laboratories. These recommendations are applicable to the postanalytical processes and the professionals involved. The Standard requires laboratories to define and document the duration and conditions of sample retention. Laboratories are also required to design an internal quality control scheme to verify whether postanalytical activities attain the expected standards. Information management requirements are also established and laboratories are required to design a contingency plan to ensure the communication of laboratory results. Instructions are finally provided about the correct use of the accreditation label in laboratory reports. A range of nations and scientific societies support that clinical laboratories should be required to obtain accreditation. With ISO 15189 being the most specific standard for demonstrating technical performance, a clear understanding of its requirements is essential for proper implementation.

Comparación de la ecuación CKD-EPI respecto a MDRD-IDMS en la derivación de pacientes a Nefrología / Comparison of CKD-EPI and MDRD-IDMS equations and referrals to specialized care

Introducción: Las Guías KDIGO 2012 recomiendan la ecuación CKD-EPI como una estimación más exacta del filtrado glomerular (FG). Realizamos un análisis retrospectivo para evaluar la concordancia entre CKD-EPI y MDRD-IDMS y para calcular el diferencial de derivaciones a Nefrología. Participantes y métodos: Para el estudio de concordancia se analizó una muestra de 16.720 solicitudes de pacientes visitados en Atención Primaria en el área de influencia del Hospital Universitario Joan XXIII de Tarragona durante un año. Para el cálculo del diferencial de derivaciones se seleccionaron 8.478 pacientes. Solo se tuvieron en cuenta parámetros de laboratorio (FG y albuminuria). Se siguieron las recomendaciones del documento de consenso sobre enfermedad renal crónica (ERC) del 2012 y se compararon con los resultados obtenidos al aplicar el documento de consenso del 2008. Resultados: Las ecuaciones mostraron una buena concordancia a nivel global (kappa = 0,94; p < 0,001). Con la aplicación del nuevo documento de consenso, CKD-EPI supuso un incremento de 9 derivaciones (12,7%) respecto a MDRD-IDMS, siendo 7 (9,9%) atribuibles al grupo de pacientes de edad superior a 80 años. Con la aplicación del antiguo documento de consenso, CKD-EPI hubiese supuesto un aumento de 28 derivaciones (7,4%) respecto a MDRD-IDMS. Conclusiones: La ecuación CKD-EPI conduce a una reclasificación de la ERC que afecta a la práctica clínica, al paciente y a la economía. En los pacientes de mayor edad se observa un aumento de las derivaciones, indicando la necesidad de aplicar en algunos casos ecuaciones de estimación del FG más exactas en este grupo de edad (AU)

Introduction: The new KDIGO 2012 Guidelines recommend CKD-EPI equation as a more accurate estimation of glomerular filtration rate (GFR). A retrospective analysis was performed in order to evaluate the correlation between CKD-EPI and MDRD-IDMS and to calculate the difference in referrals to Specialized Care using both equations. Participants and methods: A concordance study was performed comparing CKD-EPI equation to MDRD-IDMS. The sample consisted of 16,720 requests of patients seen in Primary Care in the referral area of the University Hospital Joan XXIII in Tarragona within a one year period. To calculate the difference in referrals between both equations 8,478 patients were selected from the initial sample. Only laboratory parameters were taken into account (GFR and urine albumin). The analysis used the recommendations from the current chronic kidney disease (CKD) consensus document. The results were also calculated applying the referral criteria from 2008. Results: The study showed a good correlation between both equations (kappa = 0.94, P < .001). The new consensus document involved an increase of 9 referrals (12.7%) using CKD-EPI in comparison to MDRD-IDMS, of which 7 (9.9%) were due to the group of patients older than 80 years. With the application of the old consensus document, using CKD-EPI would have had an increase of 28 referrals (7.4%) compared to using MDRD-IDMS. Conclusions: The CKD-EPI equation leads to a re-classification of CKD affecting clinical practice, the patient and the economy. An increase in the referrals of older patient was observed. In some cases, this reveals the need for applying more accurate equations to estimate GFR for this age group (AU)

Hemólisis masiva en un caso de sepsis por Clostridium perfringens / Fatal hemolysis due to Clostridium perfringens sepsis

Presentamos un caso de hemólisis masiva fulminante a causa de una sepsis por Clostridium perfringens en un paciente diabético que acude a un hospital comarcal manifestando dolor abdominal. Mostramos las imágenes de la sangre periférica obtenida antes de la muerte del paciente, que tuvo lugar 22 h después de su ingreso hospitalario (AU)

We report a case of fulminant massive hemolysis due to Clostridium perfringens sepsis in a diabetic patient who was seen in a local hospital complaining of abdominal pain. The patient died 22 h after hospital admission. We present images of peripheral blood taken before death (AU)