The Implementation of Clinical Laboratory Quality Indicators in the Era of the COVID-19 Pandemic

The use of quality indicators (QIs) and risk assessment are valuable tools for maintaining the quality of laboratory tests. Both are requirements of ISO 15189: 2012 and are usually based on standard statistical and empirical data. In this chapter, the authors focus on evaluating clinical laboratory quality indicators in the era of the COVID-19 pandemic. The goal is to pose and discuss, based on the authors' experience, the quality evaluation and risk assessment through the collection, study, and analysis of quality indicators covering the pre-analytical, analytical, and post-analytical phases of the laboratory testing process. QIs were evaluated using the Six Sigma method. Moreover, FMEA risk analysis was performed, and the degree of risk priority was assessed using the Pareto method. The results show that in the analytical phase, the laboratory's performance is satisfactory, while the pre-and post-analytical phases need further preventive/corrective actions.

Implementation of Static Telecytology Applications for Accreditation Purposes According to ISO 15189

Telecytology can be defined as the process of diagnostic cytology performed on digital images. The process of diagnostic cytology performed on digital images can be used for teaching, professional examinations, obtaining expert opinions on severe cases, and routine diagnosis of the entire laboratory workload. Ηowever, little information exists about its possible use for proficiency testing purposes. The existing studies have found a high (90%–95%) concordance between telecytological and glass slide diagnoses, but they refer to a small number of cases. Thus, the purpose of the chapter is to examine the feasibility of developing a proficiency testing scheme for cytology labs wishing to be accredited according to ISO 15189:2012 by using low-cost telemedical applications.

DIAGNÓSTICO DE ESTÁNDARES DE CALIDAD INTERNACIONALES EN LABORATORIOS DE DOCENCIA DE UNA UNIVERSIDAD ECUATORIANA

Introducción: El Laboratorio de Docencia es un sitio donde el estudiante puede acceder a ella en su proceso de aprendizaje, al igual que el Laboratorio Clínico, están ligados a normas que se deben de cumplir para poder funcionar como sitio de enseñanza, un sistema de gestión de calidad son actividades coordinas para dirigir y controlar una organización con respecto a la calidad, están definidas por la Organización Internacional de Normalización (ISO), los indicadores estándar son aplicados de manera internacional y adaptables a cualquier tipo de laboratorio. Objetivo: diagnosticar los estándares de calidad internacionales en laboratorios de docencia una universidad ecuatoriana. Métodos: diseño de estudio descriptivo y analítico de corte transversal, se utilizaron fuentes bibliográficas basadas en fuentes primarias, secundarias y terciarias, el universo total fue de 4 laboratorios de docencia; para la recolección de información de utilizaron dos instrumentos validados por la OPS/HSP/HSE y el MSP del Ecuador. Resultados: Se encontró que, del total de indicadores de la primera encuesta, el 52,6% equivalente a 20 parámetros se cumplen, mientras que el 47,4% (n:18) no lo hace; en la segunda encuesta el 53,3% (n:16) cumple con lo requerido, mientras que el 46,7% (n:14) no lo hace. Conclusiones: los indicadores estándares son importantes a la hora de la pedagogía en los laboratorios de docencia de la Carrera de Laboratorio Clínico de la UNESUM. Palabras clave: Gestión de la calidad, Normas ISO 15189, Laboratorio de Docencia, Calidad ABSTRACT Introduction: The Teaching Laboratory is a site where the student can access it in their learning process, like the Clinical Laboratory, they are linked to standards that must be met in order to function as a teaching site, a management system Quality are coordinated activities to direct and control an organization with respect to quality, they are defined by the International Organization for Standardization (ISO), the standard indicators are applied internationally and adaptable to any type of laboratory. Objective: diagnose international quality standards in teaching laboratories an Ecuadorian university. Methods: descriptive and analytical cross-sectional study design, bibliographic sources based on primary, secondary and tertiary sources were used, the total universe was 4 teaching laboratories; Two instruments validated by PAHO / HSP / HSE and the MSP of Ecuador were used to collect information. Results: It was found that, of the total of indicators from the first survey, 52.6% equivalent to 20 parameters are met, while 47.4% (n:18) do not; in the second survey, 53.3% (n: 16) met the requirements, while 46.7% (n:14) did not. Conclusions: the standard indicators are important when it comes to pedagogy in the teaching laboratories of the Clinical Laboratory Career of UNESUM. Keywords: Quality management, ISO 15189 Standards, Teaching Laboratory, Quality

Análisis de la calidad de servicio y satisfacción al cliente durante el proceso de análisis de pruebas RT-PCR COVID19 en laboratorio clínico

La investigación tiene como objetivo analizar la calidad del servicio y establecer la relación con la satisfacción al cliente, durante el proceso de análisis de pruebas RT-PCR COVID19 de un laboratorio clínico en la provincia de Manabí en el cantón Manta, la metodología a utilizar se centra en el análisis del proceso a través de un enfoque mixto con un diseño transversal descriptivo, los instrumentos para la recolección de la información son de tipo documental, observación y la encuesta, el método a utilizar es crítico e interpretativo, analítico en base a la fundamentación teórica obtenida y cuantitativo. La investigación se desarrolló de acuerdo a las siguientes actividades: identificar los protocolos de servicio durante el proceso de análisis de pruebas RT-PCR COVID19 en un laboratorio clínico y sus aspectos críticos, para este paso se realizó un análisis documental de la información generada por la empresa en donde establece el procedimiento seguido en el procesos de análisis y para analizar las características generales se usó como base del cuestionario la norma ISO 15189:2013; a continuación para conocer la percepción de la calidad por parte de los clientes del servicio de análisis de pruebas RT-PCR COVID19, se aplicó un cuestionario donde se hace un acercamiento a la satisfacción del cliente con dotes de calidad del servicio establecido por el modelo Servqual en todas sus dimensiones con una adaptación al tipo de pruebas analizadas; finalmente y a través de los resultado obtenidos y de la comparación con otros autores se propusieron acciones estratégicas que permitan mejorar la calidad del servicio de análisis de pruebas RT-PCR COVID19 en el laboratorio estudiado.

Xây dựng ngân hàng mẫu chuẩn cho đánh giá phương cách xét nghiệm chẩn đoán HIV

Theo khuyến cáo của Tổ chức Y tế thế giới, từ năm 2013, Bộ Y tế giao nhiệm vụ cho Viện Vệ sinh dịch tễ Trung ương (VSDTTƯ) xây dựng và ban hành phương cách xét nghiệm HIV quốc gia để hạn chế các sai sót trong chẩn đoán. Mục tiêu của nghiên cứu là xây dựng ngân hàng mẫu chuẩn cho đánh giá phương cách xét nghiệm chẩn đoán HIV. Ngân hàng mẫu chuẩn đã được xây dựng có tổng số 800 mẫu thu thập từ các nhóm nguy cơ lây nhiễm HIV khác nhau, cả nam và nữ với độ tuổi khác nhau, ở 5 tỉnh/thành Hà Nội, Lào Cai, Nghệ An, Lạng Sơn và Quảng Ninh. Các mẫu được bảo quản vận chuyển, đánh giá đạt yêu cầu về chất lượng và được Phòng thí nghiệm tham chiếu quốc gia về HIV- ISO 15189, Viện VSDTTƯ xét nghiệm xác định đặc tính theo tiêu chuẩn vàng gồm 488 mẫu âm tính, 297 mẫu dương tính với HIV và 15 mẫu khó chẩn đoán. Các mẫu được chia thành các ống nhỏ với thể tích 1ml/ống, có dán nhãn mã số, xếp trong hộp lưu theo sơ đồ bố trí khoa học và bảo quản ở tủ lạnh âm 70oC trở xuống. Ngoài ra, thông tin của từng mẫu được lưu trữ trong phần mềm quản lý ngân hàng mẫu phục vụ công tác tìm kiếm, xuất nhập mẫu sẵn sàng phục vụ công tác đánh giá phương cách xét nghiệm HIV.

A novel practical approach to calculate measurement uncertainty in clinical pathology laboratories using quality control data with the use of biological variation where applicable

Background: Measurement Uncertainty (MU) can assist the interpretation and comparison of the laboratory results against international diagnostic protocols, facilitate a reduction in health care costs and also help protect laboratories against legal challenges. Determination of MU for quantitative testing in clinical pathology laboratories is also a requirement for ISO 15189. Methods: A practical and simple to use statistical model has been designed to make use of data readily available in a clinical laboratory to assess and establish MU for quantitative assays based on internal quality control data to calculate Random Error and external quality assurance scheme results to calculate Systematic Error. The model explained in this article has also been compared and verified against quality specifications based on Biological Variation. Results: Examples that explain and detail MU calculations for the proposed model are given where different components of MU are calculated with tabulated results. Conclusions: The designed model is cost-effective because it utilises readily available data in a clinical pathology laboratory. Data obtained from internal quality control programs and external quality assurance schemes are used to calculate the MU using a practical and convenient approach that will not require resources beyond what is available. Such information can additionally be useful not only in establishing limits for MU to satisfy ISO 15189 but also in selecting and/or improving methods and instruments in use. MU can as well play an important role in reducing health care costs as shown by examples in the article.

Một đánh giá về khả năng tương đồng kết quả xét nghiệm công thức máu

Đánh giá tương đồng thiết bị thông qua xác nhận tương đồng kết quả phân tích là một biện pháp được sử dụng trong đảm bảo chất lượng kết quả thử nghiệm dựa vào đó đưa ra quyết định về khả năng sử dụng thiết bị trong nghiên cứu và các hoạt động xét nghiệm khác. Từ 40 mẫu máu thực địa tuyển chọn ra 03 mẫu máu toàn phần có nồng độ huyết sắc tố dưới 120 g/L, gần 120 g/L và trên 120 g/L được xét nghiệm lặp lại 7 lần/ mẫu bởi 3 phòng xét nghiệm riêng biệt. Đánh giá tương đồng thiết bị thông qua tương đồng về kết quả tiến hành theo 3 cặp (2 phòng/ cặp) cho kết quả tốt nhất về độ tương đồng độ chụm/ độ lặp lại ở các cặp phòng có liên quan đến hoạt động vận hành và được chứng nhận ISO 15189. Độ tương đồng về giá trị trung bình cho 2 phương sai đồng nhất và không đồng nhất chưa tốt ở tất cả các phòng tham gia.

Patients’ (Clients) Satisfaction with Medical Laboratory Services Contributes to Health and Quality Improvement

Patients’ (clients/customer) services and satisfaction in Medical Laboratory Services and general healthcare is one of the twelve (12) quality essentials of Total Quality Management System (TQMS) emphasized by quality standards as seen in ISO 17025, ISO 15189 and ISO 9001. The patients otherwise referred to as customers or clients to Medical Laboratory and healthcare in general, is the heart-beat and kings to the healthcare system. This chapter looks into the quality aspect of medical laboratory services from the patients’ angle towards thorough satisfaction or dissatisfaction index and otherwise creates room for improvement in the services and healthcare in general. The chapter therefore, identified medical laboratory clients to include patients and patients’ relations, physicians and other healthcare workers, public health and government, communities and interested parties, and medical laboratory profession. There is a need to administer services satisfaction survey developed by Director of Medical Laboratory Services or human resources/quality officers in line with the ISO 15189, ISO 17075 and ISO 9001 to customers/clients from time to time so the outcome can be used to correct services errors and cause quality improvement. It is believed that patients’ satisfaction causes improvement in healthcare, quick recovery of patients and willingness of the patient to return to the healthcare facility in future. Patients’ and customers’ in medical laboratory feedback contributes to quality management and improvement to Medical Laboratory services and healthcare as an ingredient of TQMS.

Serological diagnostic for SARS-CoV-2: an experimental External Quality Assessment Scheme

Objectives Numerous analytical systems, rapidly made available on the market throughout the SARS-CoV-2 pandemic, aim to detect COVID-19, and to continuously update and improve the same systems. Medical laboratory professionals have also developed in-house analytical procedures in order to satisfy the enormous volume of requests for tests. These developments have highlighted the need control the analytical procedures used in order to guarantee patient safety. The External Quality Assessment (EQA) Scheme, an important quality assurance tool, aims to guarantee high standard performance for laboratory and analytical procedures. The aim of the present study was to report on the results collected in an experimental EQA scheme for the serological diagnosis of SARS-CoV-2. Methods All qualitative results collected in the different EQA surveys were summarized in order to identify the percentage of laboratory results in relation to typology of antibodies, results and samples. Results A total of 4,867 data sets were collected. The analysis of EQA data made, demonstrates a better agreement among laboratories results for total Ig than single immunoglobulins (IgG, IgM, IgA) in the case samples positive for SARS-CoV-2, and a wide divergence between IgM results for positive samples (only 34.9% were correct). Results for negative controls and specificity controls demonstrated a better overall agreement than results for positive samples. Conclusions Working in collaboration with the IVD manufacturers, laboratory professionals must strive to achieve harmonization of results, and to develop well-defined protocols complying with the ISO 15189 requirements.