Fundamentos teóricos para un sistema de gestión de la calidad en el Laboratorio Provincial de Biología Molecular

El establecimiento de un sistema de gestión de la calidad es obligatorio para algunas instituciones de salud, entre las que se encuentra el Laboratorio de Biología Molecular, esto queda explícito en la Regulación D 03-21, que plantea la obligatoriedad de su cumplimiento para los laboratorios clínicos que se basan en técnicas de biología molecular. El objetivo del presente texto es exponer los presupuestos teóricos que sustentan un estudio sobre la gestión de la calidad en el mencionado laboratorio. Se realiza una revisión documental a partir de artículos publicados en el período comprendido de 2012-2022. Del total de las fuentes consultadas en las plataformas de acceso a bases de datos de la red de información de la salud cubana Infomed: PubMed, Scopus, SciELo, Redalyc, y Dialnet, se seleccionaron 33 para la revisión al considerar que abordaban el tema con mayor profundidad. La adopción de un sistema de gestión de la calidad garantiza y gestiona el alto nivel de los servicios, aumenta la satisfacción del cliente y el prestigio de la organización.

The establishment of a quality management system is mandatory for some health institutions, among which is the Molecular Biology Laboratory. This is explicit in Regulation D 03-21, which makes compliance mandatory for laboratories. clinical trials that are based on molecular biology techniques. The objective of this text is to present the theoretical assumptions that support a study on quality management in the aforementioned laboratory. A documentary review is carried out based on articles published in the period from 2012-2022. Of the total sources consulted on the database access platforms of the cuban health information network Infomed: PubMed, Scopus, SciELo, Redalyc, and Dialnet, 33 were selected for the review considering that they addressed the topic with greater depth. The adoption of a quality management system guarantees and manages the high level of services, increases customer satisfaction and the prestige of the organization.

Research on mixed teaching platform of pediatric clinical laboratory practice teaching based on the Laboratory Quality Management System / 中华医学教育探索杂志

Objective:To explore application of mixed teaching platform in the clinical practice teaching of the laboratory medicine in Children's hospitals.Methods:We constructed a mixed online and offline teaching platform based on the Laboratory Quality Management System (LQMS) in the Children's Hospital of Chongqing Medical University. The undergraduates from Batch 2016 ( n=15) and Batch 2018 ( n=12) of College of Laboratory Medicine of Chongqing Medical University were taken as control group and experimental group respectively. Traditional teaching method was adopted by the control group, and the mixed teaching method was adopted by the experimental group. The results of two groups' clinical practice assessment, rate of outstanding students (total score ≥ 90) and rate of satisfaction (score ≥ 90) were compared to evaluate the teaching effect. SPSS 17.0 was used to conduct t-test and Chi-square test. Results:The database of teaching platform includes 68 teaching cases, 198 pieces of courseware, 305 clinical cases and 3 036 atlases. The test bank has accumulated 4 657 tests, covering clinical laboratory, immunology, biochemistry, microbiology and blood transfusion. The results of students in experimental group were significantly better than those of the control group [the score of clinical practice assessment: (85.90±5.04) vs. (78.90±6.75)( P<0.05); rate of outstanding students: 33.3% (4/12) vs. 6.7% (1/15), P>0.05; rate of satisfaction: 86.7% (13/15) vs. 100.0% (12/12) ( P>0.05). Conclusion:The mixed online and offline teaching platform based on the LQMS is highly recognized by students and can significantly improve the effect of clinical practice teaching, which can provide typical medical case teaching at any time and make up for limited case type in children's hospital.

Discussion on Key Control Points and Common Problems of Molecular Diagnostic Reagents in the Process of Design and Development / 中国医疗器械杂志

Design and development process of molecular diagnostic reagents is critical to quality management system of in vitro diagnostic reagent. Based on the technical characteristics of molecular diagnostic reagents, the study analyzed the concerned key control points and common problems in the process of design and development from the view of registration quality management system. It aimed at offering technical guidance on design and development process of molecular reagents and registration quality management system to enterprises, thus improving the product development efficiency, optimizing the quality management system, and increasing the efficiency and quality of registration and declaration.

Discussion on the Authenticity Verification Method in the Verification of Medical Device Registration Quality Management System / 中国医疗器械杂志

Authenticity verification is a very important aspect of medical device registration quality management system verification of medical device. How to verify the authenticity of samples is a problem worth discussing. This study analyzes the methods of authenticity verification from the aspects of product retention sample, registration inspection report, traceability of records, hardware facilities and equipment. In order to provide reference for relevant supervisors and inspectors in the verification of registration quality management system.

Evaluation and improvement of blood station quality management system: based on external audit / 中国输血杂志

【Objective】 To identify the main unqualified items in the external audit of blood station quality management system (referred to as external audit), in order to take necessary measures to continuously improve the quality system. 【Methods】 Unqualified items(data) in the national and Shandong provincial blood safety technical audits (referred to as national and provincial audits) and four blood station blood safety technical joint audits (referred to as inter station mutual audits) from 2017 to 2019 were collected and analyzed by Excel and Pareto curves (graphs). Corresponding corrective and preventive measures were developed and implemented, and then tracked and evaluated by the quality management department three months after the external audit to verify their effectiveness. 【Results】 In a total of 7 external audits of blood station quality management system that our blood station has participated in over the past 3 years (including 2 national audits, 2 provincial audits, and 3 inter station mutual audits), the main unqualified terms were "12 monitoring and continuous improvement" 11.90% (15/126), "13 blood donation services" 11.90% (15/126), "06 equipment" 10.32% (13/126), "11 records" 10.32% (13/126), "03 organization and personnel" 8.73% (11/126), "15 blood preparation" 7.94% (10/126), "08 safety and health" 7.14% (9/126), and "14 blood testing" 7.14% (9/126). Among them, "monitoring and continuous improvement" ranked first in two national audits and two provincial audits, with 16.67% (5/30) and 14.71% (5/34), respectively, and was 8.06% (5/62) in inter station mutual audit, and the difference between the three kinds of audits was not statistically significant (P>0.05). "Records" accounted the highest proportion in inter station mutual review of 19.35% (12/62), while was respectively 0 and 2.94% (1/34) in national and provincial audits, with statistically significant difference between the three kinds of audits (P<0.05). 【Conclusion】 External audit against unqualified items is important for quality improvement. By analyzing the unqualified terms, taking corresponding measures to improve weak links, and evaluating the effectiveness of those measures, it can effectively ensure the effective operation of blood station quality management system.

Practice and exploration of training for clinical, teaching and scientific research ability of cardiovascular specialists / 中华医学教育探索杂志

Standardized training of specialists is an important part of medical education system. The training goal is to cultivate high-quality specialists with high clinical practice ability, teaching and scientific research ability. Based on the training practice of clinical, teaching and scientific research ability of the standardized training of cardiovascular specialists in Peking University Third Hospital, this paper discusses how to establish and improve the quality management system of cardiovascular specialist training, and introduces the training content, training methods, training organization and management, and training effect respectively, hoping to provide more practical basis for improving the quality of standardized training for cardiovascular specialists.

Antecedentes de los Procesos Iniciales de Acreditación de los Programas de Especialidades Odontológicas de La Universidad de La Frontera - Chile

RESUMEN: Este artículo presenta la experiencia y resultados de la Facultad de Odontología de la universidad de la Frontera al implementar un proceso a-priori de autoevaluación a la creación de los criterios para especialidades odontológicas de la Comisión Nacional de Acreditación (CNA-Chile), para luego entrados en vigencias éstos, se enviaron las tres primeras especialidades odontológicas a procesos de acreditación en Chile. Lo que generó que sea la primera Facultad de Odontología que implementara un Sistema de Gestión de Calidad, impulsando por búsqueda de la mejora continua de sus programas de especialidad.

ABSTRACT: This article presents the experience and results of the Dental School of the La Frontera University, when implementing a-priori process of self-assessment to the creation of the criteria for dental specialties of the CNA- Chile, the first three dental specialties were sent to accreditation processes in Chile. What generated that it is the first Dental School to implement a Quality Management System, driven by the search for the continuous improvement of its specialty programs.

Exploration of "Speed Dial Management" Model for Medical Device "MAH Policy" / 中国医疗器械杂志

This article expounds relevant policies of domestic medical device "MAH Policy" in recent years. When facing new development opportunities at this time of policy innovation, "Speed Dial Management" model summarized through the practice of "MAH Policy", together with the core elements of "three parties, three regulations and three flows" extracted from it, form a standardized, implementable and reproducible management mechanism. The experience has strong reference significance for the promotion and implementation of "MAH Policy" among medical device industry.

Discussion on Technical Review Guidance for Registration of Personalized Additive Manufacturing Medical Devices of Passive Implantable Bone, Joint and Oral Hard Tissues / 中国医疗器械杂志

OBJECTIVE@#This paper introduces the key content and background of Technical Review Guidance for the Registration of Personalized Additive Manufacturing Medical Devices of Passive Implantable Bone, Joint and Oral Hard Tissues.@*METHODS@#The core contents and importance of the construction of personalized design validation and verification and additive manufacturing system are described respectively.@*RESULTS@#The personalized design needs to be carried out under the control of interactive cooperation between healthcare professional and engineer. And the performance of personalized device must be validated and verified completely. At the same time, in view of the particularity of the quality management system of additive manufacturing, the technical focus is expounded.@*CONCLUSIONS@#New ideas and methods shall be used in evaluate and administrate personalized additive manufacturing medical device.

Research on Current Situation of Quality Management of Artificial Intelligence Medical Device Enterprises / 中国医疗器械杂志

OBJECTIVE@#To understand the current situation of artificial intelligence production enterprise quality management system, so as to provide reference basis for the research and standardization of Artificial Intelligence Medical Device (AIMD) product quality management.@*METHODS@#Based on YY/T 0287-2017 Medical Device Quality Management System for Regulatory Requirements, Medical Equipment Production and the Quality Control Standard for Independent Software Appendix and Xavier GMLP report, the relevant factors were screened and the questionnaire was designed by combining expert consultation and literature review. Then, a total of 32 representative AIMD enterprises were invited to fill in the questionnaire. Descriptive statistical analysis was performed on the data results using Excel 2016.@*RESULTS@#Through in-depth analysis of the four themes in product planning and design, result output, product quality control and product change, it was found that it was necessary for enterprises participating in the survey to improve the quality management system of AIMD products to different degrees.@*CONCLUSIONS@#This study is the first time to systematically investigate the status quo of quality management of AIMD enterprises. The result will be useful for the establishment and continuous improvement of product quality management system. It will also provide a reference for the research of AIMD product quality management and the establishment of the standard.

Research and Application of Quality Inspection Information System in Medical Device Manufacturers / 中国医疗器械杂志

OBJECTIVE@#To improve the production and inspection efficiency of medical device manufacturers, improve the quality system management level of manufacturers, and ensure the safety and effectiveness of medical devices.@*METHODS@#Sort out the business process of the medical device manufacturer, connect the database of production and ERP system to inspection system, and build the operation software for the quality control department.@*RESULTS@#The system has covered all the products of the manufacturer, and has realized the informatization and visualization of the inspection process.@*CONCLUSIONS@#The research and application of the system can improve the quality management traceability system of medical device manufacturers, and improve the efficiency and accuracy of medical device quality inspection.

Study of staff employee’s satisfaction / Монголын Анагаах Ухаан

Introduction@#Studies in many countries have found that the satisfaction of medical workers is closely linked to the quality and efficiency of medical services, as well as the satisfaction of patients. Satisfied employees will bring about satisfied clients. The satisfaction of employees remains a key factor linking the internal management and external management of an organisation. The World Health Organization (WHO) Global strategy on human resources on health workforce 2030 sets out the policy agenda to ensure a workforce that is ft for purpose to attain the targets of the Sustainable Development Goals (SDGs). Motivation of health care workers can initiate them to exert and maintain an efort towards organizational goals. Motivation depends up on many factors, and job satisfaction is one of the most important factors. Healthcare is a service industry where the overall service experience is important for customer satisfaction and quality of care (even if in different extents according to the professional at stake) and that the literature has been bringing about the pertinence of such a holistic approach, this research was conducted within this perspective. Likewise, it is also known that there is close correlation between the job satisfaction of health care staff and the total quality of health services. Different groups have reported differences between the job satisfaction of doctors and that of other health providers. Various satisfaction levels of health care workers, including general practitioners, nurses and midwives, have been reported previously. @*Materials and Methods@#This study was performed at the Amgalan Maternity Hospital, Urguu Maternity Hospital and Khuree Maternity Hospital The study involved 480 employees of above mentioned hospitals. The short form of the Minnesota Satisfaction Questionnaire, with 20 items, was used to examine satisfaction with professional life. The self-administered questionnaire was distributed to all people at their workplaces. Responses of 4 (satisfied) or 5 (very satisfied) were classified as ‘satisfied’, those of 1 (very dissatisfied) or 2 (dissatisfied) as ‘dissatisfied’.@*Results@#The study recruited total 480 employees consisting of 220 employees working at Urguu Maternity Hospital, 125 employees of Khuree Maternity Hospital and 135 employees of Amgalan Maternity Hospital. 46 administration officials, 75 doctors, 208 nurses and obstetricians, 105 caregivers and service assistants and 46 economic employees involved it. In table, 87.1% of total employees of maternity hospitals were female and 12.9% were male. While there had significantly difference for gender, occupation type and worked year in this sector and workplace between 3 maternity hospitals (p<.001), age and education level had no significantly difference between these 3 groups. The proportion of health care staff satisfied with their work was 80.7%. The chance to tell people what to do’ and ‘Being able to do things that do not go against my conscience’, and mostly dissatisfied with ‘The working conditions’ and ‘My pay and the amount of work I do’. There was no significant difference between satisfaction scores of health care staff according to age, gender, marital status, and experience of profession. When the 20 items constituting job satisfaction were examined specifically, the satisfaction score showed a difference related to profession. The midwives’ satisfaction score was significantly lower than that of the others. In table 4, to assess employee’s satisfaction of each maternal hospital: While the minimum satisfaction was assessed by employees of Urguu maternity hospital whether salary is equal for work performance, the maximum satisfaction was assessed by employees of Amgalan maternity hospital under scope of consistent workplace at 93.9 percent. @*Conclusion@#Maternity satisfy external and internal factors of employees are influenced. Maternity is different, depending on the satisfaction of other working areas of employment.

Preliminary Review of Relationship between Medical Device Evaluation and Quality Management System in Premarket Approval / 中国医疗器械杂志

This paper analyzed the current reform of review and approval mechanism for medical devices and discussed the method for technical review process extending to product quality controllable direction and found the measures and suggestions to strengthen technical review for quality management system with the help with complementary relationship between the technical review and the quality management system assessment of the pre-market registration. Nowadays, because of the demand of eRPS， MAH and the amendment of regulation, the integration of technical review and quality management system is more important, necessary and scientific. Scientific and systematic evaluation should be carried out to strengthen the pre-market approval of medical devices and ensure the safety and effectiveness of medical products.

Research on Marketing Permission of Cross-border Transfer Production of Medical Devices / 中国医疗器械杂志

At present, there is a growing call for overseas registration applicants to transfer the products that have been approved for import registration to China's domestic production. It deserves our regulatory authorities to study how to face and properly deal with this issue. First of all, this paper systematically combs the regulatory requirements of FDA, EU and Japan on the change of manufacturing site address. Secondly, the paper briefly analyzes the current regulatory differences between domestic and imported devices. Finally, according to the experience and practice of foreign countries, combined with the actual situation of our country, this paper puts forward suggestions on how to meet the needs of overseas registrants to transfer products to domestic production.

To construct of quality improvement program system and to promote the transition development of organ transplantation / 器官移植

As proposed in 2019 Annual Congress of the Chinese Society of Organ Transplantation, the overall objective of the development of organ transplantation in China is to deepen the structural reform of the supply side comprehensively, to promote the transition of organ transplantation from the quantitative scale model to the quality-lifting type, and to promote the scientific, balanced, standardized and high-quality development of organ transplantation. This paper introduces the construction of quality management system and the implementation of quality improvement program in the field of surgery and transplantation in the United States, summarizes the preliminary work of how to combine foreign experience to promote the construction of quality improvement program of renal transplantation in our country, and proposes the idea of extending the quality improvement program of organ transplantation.

Impacto de la implementación de un sistema documental en el aseguramiento de la calidad en un laboratorio de análisis clínicos de un hospital público / Impact of the implementation of a documentary system on quality assurance in a clinical analysis laboratory of a public hospital

El objetivo de este trabajo fue establecer el impacto de la implementación de un sistema de gestión de calidad (SGC) en el desempeño del laboratorio de análisis clínicos del Hospital Materno Provincial. Se diseñaron diez indicadores de calidad (IC), que se midieron pre y posimplementación del sistema documental. Se encontró para el indicador solicitud médica incorrecta (SMI) una disminución de 11,2% a 6% cuando se implementó la gestión documental. Para el indicador omisión del diagnóstico (OD), el porcentaje bajó de 41,6% a 27,9% luego de la intervención. Se encontró un 5% de errores en ingreso al sistema informático del laboratorio (EI-SIL) en situación basal y 3,9% posimplementación, mientras que el indicador muestras mal remitidas (MMR) disminuyó de 3,1% a 1,9%. El 58% de los analitos disminuyó el índice de error total (IET) y el 80% aumentó el valor de sigma luego de la intervención. El 61% de los analitos disminuyó el valor de incertidumbre, mejorando de esta manera el desempeño de los métodos analíticos. El porcentaje de valores críticos (VC) comunicados al médico terapeuta antes de los 60 minutos aumentó del 20 al 54% después de la implementación de la gestión documental, mientras que el indicador reimpresión de informes (RI) disminuyó de 5,2 a 1,8%. El tiempo de respuesta (TAT) disminuyó de 164 a 125 minutos. La implementación de un SGC bajo los requisitos de normas internacionales mejoró el conocimiento y funcionamiento de los procesos del laboratorio clínico, evidenciado por la disminución de los errores en las etapas preanalítica, analítica y posanalítica.

The purpose of this study was to analyze the impact of implementing a quality management system (QMS) in the performance of a clinical laboratory of Hospital Materno Provincial. Ten quality indexes (QI) have been designed; they were measured before and after the implementation of the document management system (DMS). For the "incorrect medical application" index, there was a reduction from 11.2% to 6% when the DMS was implemented. For the "diagnostic omission" index, the percentage decreased from 41.6% to 27.9% after the implementation. Five per cent of mistakes were found in the admission of the laboratory computer system in the baseline state and 3.9% of the mistakes were found after implementation of the system. Meanwhile, the "incorrect sent samples" index decreased from 3.1% to 1.9%. Fifty eight per cent of the analytes decreased the total error index and 80% of them increased the sigma value after the intervention. Sixty one per cent of the analytes decreased the uncertainty value, thus improving the performance of analytical methods. The percentage of critical values communicated to the physician before the 60 minutes increased from 20% to 54% after the implementation of the DMS, while the "reprint of reports" index decreased from 5.2% to 1.8%. The turn around time (TAT) decreased from 164 to 125 minutes. The implementation of a QMS, under the requirements of international standards, improved the knowledge and the functioning of different processes of the clinical laboratory. This has been evidenced by the decrease of mistakes in the pre-analytical, analytical and post-analytical phases.

O objetivo deste trabalho foi estabelecer o impacto da implementação de um sistema de gestão de qualidade (SGC) no desempenho do laboratório de análises clínicas do Hospital Materno Provincial. Foram desenhados dez indicadores de qualidade (IQ), que foram medidos antes e depois da implementação do sistema documental. Foi achada uma diminuição de 11,2% para 6% no indicador solicitação médica incorreta, (SMI) quando se aplica a gestão documental. Para o indicador omissão do diagnóstico, a porcentagem baixou de 41,6% para 27,9% após a intervenção. Foram encontrados 5% de erros em entrada ao sistema informático do laboratório (EI-SIL) em situação basal e 3,9% pós-implantação, enquanto que o indicador amostras mal encaminhadas (AME) diminuiu de 3,1% para 1,9%. cincuenta e ocho por ciento dos analitos diminuíram o índice de erro total (IET) e 80% aumentou o valor de sigma após a intervenção. Sesenta e uno por ciento dos analitos diminuiu o valor de dúvidas, melhorando desta maneira o desempenho dos métodos analíticos. A porcentagem de valores críticos (VC) comunicados ao médico terapeuta antes dos 60 minutos aumentou de 20 para 54% depois da implementação da gestão documental, enquanto que o indicador reimpressão de relatórios diminuiu de 5,2 para 1,8%. O tempo de resposta diminuiu de 164 para 125 minutos. A implementação de um SGC sob os requisitos de normas internacionais melhorou o conhecimento e funcionamento dos processos do laboratório clínico, evidenciado pela diminuição dos erros nas etapas pré-analítica, analítica e pós-analítica.

Solution to Unify the Review of Domestic Second Class Medical Device / 中国医疗器械杂志

In October 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued "The opinion on deepening the reform of the review and approval system and encouraging the innovation in pharmaceutical and medical devices" which clearly requires the unification of the evaluation stand for the second class medical device and realizes national review gradually. According to this requirement, this paper firstly reviews situation of foreign medical device evaluation system, and then introduces general situation of medical device review in our country, including the establishment of institutions and existed problem of medical device registrations, and corresponding reasons are also be analyzed. Finally we focus on giving proposal on how to realize the unification of class Ⅱ medical device technology review in China combined with real situation based on referring foreign experience.

Introduction of Quality Management System Audit in Medical Device Single Audit Program / 中国医疗器械杂志

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.

Thoughts on the Witnessed Audit in Medical Device Single Audit Program / 中国医疗器械杂志

Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.