internationally leading! AI-PBRTQC Intelligent real-time quality control leads the new era of inspection and quality control

2024-07-04 5686

PBRTQC Definition and domestic and international industry guidelines

Real time quality control based on patient data (PBRTQC) It is a method of testing results through clinical specimens of patients, real-time, Quality control method for continuous monitoring, detection, analysis of the entire process and stability of analysis performance, Compared with traditional quality control methods, it has many advantages, Including continuous real-time monitoring and detection system analysis performance, Analyze errors, Sensitive to pre analysis errors, No matrix effect, No additional cost, Can be used for monitoring the analytical performance of projects without quality control products, PBRTQC Joint quality control products QC Conducting quality control can form a comprehensive quality management plan (TQC) , It is a new quality control strategy based on patient risk.

Related to domestic and international guidelines and industry standards PBRTQC Related suggestions:
2011 The American Society for Clinical and Laboratory Standardization releasedEP23-A Recommendations for Laboratory Quality Control Approval Guidelines Based on Risk ManagementIncrease patient data quality control method, In the case where the number of patients and the distribution of test results are relatively stable, This method not only eliminates matrix effects, It can also monitor the distribution trend of patient test results over time and the systematic error of the detection system.

2018 The health industry standards of the People's Republic of China issued in WS/T641-2018 Clinical Laboratory Quantitative Determination Indoor Quality Control GuidelinesWe have also added quality control methods for applying patient data for quality control, And it is recommended to use the median value of the percentile method for inter laboratory comparison of test results.

IFCC PBRTQC working groupSeparate from 2019 Year and 2020 Guidelines have been released annually, right PBRTQC Requirements for Information System Characteristics, Innovation requirements, Program establishment, Provide guidance for performance validation and clinical implementation, PBRTQC The expert group proposed PBRTQC Will become the main quality control method in clinical laboratories, And it is recommended to widely apply it in clinical laboratories.

ISO15189: 2022 New version of guidelines requirements: When suitable indoor quality control products cannot be obtained, Laboratories should consider using alternative methods for indoor quality control. Examples of other methods include: Trend analysis of patient outcomes, for example: Floating mean of patient outcomes, Or the result is lower or higher than a specific valuePercentage of samples, Percentage of samples related to diagnosis or results. The method of recording result data should be able to detect trends and drifts, when applicable, Statistical techniques should be used to review the results.


Cross Strait cooperation, Creating a New Future of Smart Laboratory Medicine Together

recently, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineandFudan University Affiliated Zhongshan Hospital Qingpu BranchWe have received a special visitor, Chairman Cai Zongren, the leader of inspection industry in Taiwan, China, China. in PBRTQC Under the warm invitation and accompaniment of Professor Wang Xuefeng, Director of the Laboratory Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and Professor Gong Qian, Director of the Laboratory Department of Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University, the benchmark hospital for national demonstration leading units, President Cai Zongren visited Senxu Medicalbased on AI The intelligent real-time quality control platform for patient data real-time quality control (AI-PBRTQC) The clinical practical application of. This is a test of cross-strait intelligence and PBRTQC clinical application, Significant milestone significance.

In the forefront exploration of promoting smart healthcare and quality control in testing, Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital and Fudan University Affiliated Zhongshan Hospital Qingpu Branch PBRTQC The clinical application of the field has taken the lead in setting a national demonstration benchmark in China. Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicinePioneering the use of Senxu Medical in China AI-PBRTQC Intelligent real-time quality control platform, adopt PBRTQC  EWMA law, Median method and artificial intelligence technology are used for the overall and branch areas of the hospital2 ahospital campus, 7 aprofessional group, 271 aReal time dynamic monitoring of the stability of project testing system analysis performance and consistency of instrument inspection results, Intelligent comparison and intelligent warning. Including clinical blood analysis projects, Chemiluminescence project, Specific protein analysis project, Clinical Mass Spectrometry Project, 1046 abased on AI of PBRTQC Intelligent monitoring model for quality risk, 1152 abased on AI of PBRTQC Real time comparison model. Fudan University Affiliated Zhongshan Hospital Qingpu BranchHitachi Biochemical Assembly Line Middleware in Collaboration with Senxu Medical AI-PBRTQC Intelligent real-time quality control platform, adopt various PBRTQC Quality control methods and artificial intelligence technology, establish128 aClinical Biochemistry Project, 436 abased on AI of PBRTQC intelligenceReal time quality controlModel and1312 abased on AI of PBRTQC Real time comparison model, Analyze the stability of the performance of the assembly line detection system, Real time intelligent monitoring of consistency of instrument inspection results and patient quality risks.

Based on Senxu Medicine AI-PBRTQC Intelligent real-time quality control platform displays real-world big data and clinical application results, Shanghai Jiao Tong University Affiliated Ruijin Hospital and Fudan University Affiliated Zhongshan Hospital Qingpu Branch Quality Management System Specification, The detection system has stable performance analysis, excellent, Accurate inspection results. Real time dynamic intelligent monitoring of quality risks, Smart Early Warning, Ensure the accuracy of the results, Reduce medical risks, Realize the intelligence of quality risk management, visualization, Real time and controllability. 2 Under the leadership of Professor Wang Xuefeng and Professor Gong Qian, the benchmark hospital adheres to the concept of practical and innovative discipline construction, Adhering to the original intention of ensuring patient quality and medical safety, Leading the way in introducing based AI of PBRTQC New quality management tool, Continuously improving the quality of medical care, Strive to provide accurate information for clinical practice, timely, efficient, Quality service, Realize the construction of a people-oriented smart laboratory.


President Cai Zongren visited the site and met with Professor Wang Xuefeng, Director of the Laboratory Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Professor Gong Qian's team, Director of the Laboratory Department of Qingpu Branch of Zhongshan Hospital Affiliated to Fudan Universityon-site communication, President Cai Zongren's speech on Senxu Medical AI-PBRTQC The functional features of the intelligent real-time quality control platform, professionalism, innovativeness, The clinical application value and model establishment methods have gained a more intuitive understanding and comprehension.

After visiting, President Cai expressed his gratitude to Professor Wang Xuefeng, Director of the Laboratory Department at Ruijin Hospital, and Professor Gong Qian, Director of the Laboratory Department at Qingpu BranchAdmiration for innovative thinking in the construction of intelligent laboratories: The pioneering role of smart laboratory construction! Professor Wang Xuefeng, Director of the Laboratory Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and Professor Gong Qian, Director of the Laboratory Department of Qingpu Branch of Zhongshan Hospital Affiliated to Fudan UniversityTargeting the forefront of medical technology development in the construction of intelligent laboratories, Adhering to the concept of safeguarding the health of patients, dedication, lean, focus, innovation, Continuously strengthening quality awareness, Actively promote the intelligent construction of clinical laboratories and improve the level of quality management, Ensure the accuracy of the inspection results. Professor Wang Xuefeng and Professor Lu Yide's team from Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Dong Danfeng andFudan University Affiliated Zhongshan Hospital Qingpu BranchProfessor Gong Qian's team, including Xu Limingin SCI Publish the latest research results in domestic professional core journals 3 piece, Group standard writing 1 item, monograph 1 ministry, It reflects the exploration and innovation, The spirit of striving for progress, Emphasis on the development of disciplines and quality and safety, Played a demonstrative role domestically.


Professor Wang Xuefeng, Chief Physician, Ph. D. supervisor, Leader of the Laboratory Department at Ruijin Hospital. Current Director of the Experimental Diagnosis Center at Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Vice Dean of School of Medical Technology, Shanghai Jiao Tong University School of Medicine, Chairman of the Laboratory Branch of Shanghai Medical Association, etc, Hosted by the National Natural Science Foundation of China, Shenkang Three Year Action Plan, Multiple research projects including the Peak Plateau Discipline Plan, As the corresponding author Blood, ATVB, Science Bulletin, Haemotologica Waiting for the publication of papers in journals 100 remaining articles. Won successively "Leading Talents in Shanghai" , "First Prize of Shanghai Science and Technology Progress Award" , "Second Prize for Scientific and Technological Progress of the Ministry of Education" Waiting for multiple awards.


President Cai Zongren and Professor Wang Xuefeng, Director of the Laboratory Department of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Professor Lu Yide, head of the Clinical Chemistry Group, Group photo of Professor Dong Danfeng, the technical leader of the biochemical group, and other intelligent construction innovation teams



Professor Gong Qian, Director of Laboratory Department, Qingpu Branch, Zhongshan Hospital Affiliated to Fudan University, Head of Qingpu District Regional Inspection Center. Member of the Laboratory Medicine Specialty Branch of Shanghai Medical Association, Deputy Leader of the District Cooperation Group; Member of the Laboratory Physicians Branch of the Shanghai Medical Association; Vice Chairman of the Inspection and Health Special Committee of Shanghai Rehabilitation Medicine Association; Deputy Leader of the Management Group of the Second Laboratory Medicine Branch of the Shanghai Association of Traditional Chinese Medicine; Vice Chairman and Secretary General of the Regional Inspection Committee of the Norman Bethune Spirit Research Association; Experts in the construction of the health talent evaluation question bank at the Talent Exchange Service Center of the National Health Commission.

President Cai Zongren and Professor Gong Qian, Director of the Laboratory Department of Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University, Vice Director Professor Wang Jinjin, Professor Xu Ran, the leader of the Biochemistry Group, exchanged and took a group photo with the Intelligent Construction Innovation Team


National pride--Senxu Medical AI-PBRTQC Intelligent real-time quality control platform

President Cai Zongren is the founding director of Taiwan, China Medical Experiment Management Association, ISO15189 Expert consultant recognized by the quality management system of medical laboratories, We have been committed to exploring, practicing, and promoting innovative methods for quality management in medical laboratories ISO15189 recognize, And focus on international PBRTQC Research progress on applications. This visit, President CaiWen Dongmei, Chief Expert of Senxu Medical, and AI-PBRTQC Innovation of Intelligent Real time Quality Control Platform, cutting-edge, The professionalism and clinical application effectiveness have been highly recognized as follows:

one, Medical examination dreams come true
Patient data quality control method is an existing quality control theory, Due to insufficient computer functionality in the early years, Unable to implement the theory. In recent years, traditional quality control using quality control products has been unable to monitor all inspection and analysis errors, Especially errors from patient sample system bias, Unable to meet the demand for ensuring inspection quality, Therefore, the use of patient outcome quality control methods has received renewed attention, And rely on the development of Internet technology progress, Enable it to be implemented in daily inspection work, But the model building method is complex, Information software has high requirements, Difficult to popularize and apply in clinical practice, Senxu Medical AI-PBRTQC Intelligent real-time quality control platform overcomes international challenges PBRTQC Difficulties and bottlenecks in promoting clinical applications, Make the dream of medical examination come true.

two, Leading global technology
Senxu Medical Company's AI-PBRTQC The intelligent real-time quality control platform is an independent application of artificial intelligence and big data mining technology PBRTQC Professional software tools, It's from the references I've seen beforeCurrently the most advanced in the world, The most versatile patient data real-time quality control intelligent monitoring platform, fully comply with IFCC related to PBRTQC Professional software functional features, Program establishment, Technical requirements for implementation and operation, The technological content far exceeds that of similar products internationally, It is the pride of all Chinese people.

three, Leadership creates success
Director Wen Dongmei is a professional inspection technician, none IT Technical Background, But able to lead someone without a medical background IT engineer, Utilize cross disciplinary team collaboration, Successfully developed Senxu Medical AI-PBRTQC Intelligent real-time quality control platform, In addition to the abilities and efforts of team members, I personally think it is Director Wen's professional competence and belief, And her innovative ability and leadership, Can give birth to AI-PBRTQC The intelligent real-time quality control platform is a commercially valuable product, Director Wen is truly a medical examination genius.

Through this visit and exchange, President Cai Zongren not only fully understood Senxu Medical's advanced concepts and technological strength in smart laboratories and smart testing products, but also, Further deepened the understanding of the development trend of laboratory medicine. President Cai Zongren is a leading expert with a strong sense of mission to promote the development of the industry, President Cai stated that: He is full of confidence in the future development of laboratory medicine, And firmly believe that in the near future, China is expected to surpass European and American countries, Expecting Chinese people to become PBRTQC Leaders in the world! Enhance the level of quality management, satisfy ISO15189 New version of guidelines requirements, Ensure patient medical safety, Further promote the progress and development of the smart inspection industry.

President Cai, the industry leader in Taiwan, China, spoke highly of the AI-PBRTQC Intelligent real-time quality control platform holds an outstanding position in the global medical technology field.


Billion level data! Senxu Medical AI-PBRTQC Intelligent real-time quality control platform

Senxu Medical is based on AI of PBRTQC Intelligent real-time quality control platform (AI-PBRTQC)
Senxu Medical is based on AI The intelligent real-time quality control platform for patient data real-time quality control (AI-PBRTQC) , Modeling based on international quality control management theory and authoritative statistical methods of national industry standards, It is the first independent product launched domestically, Original independent research and development using artificial intelligence and big data mining technology PBRTQC Professional intelligent quality control software tool, Highly praised by international experts for leading the international level.

so far, Including the total number of top tier tertiary hospitals in China100 multipleThe hospital participatedLed by Senxu Medical, China based AI of PBRTQC Real world big data performance validation and clinical application multi center demonstration project, Including large tertiary hospitals, Regional Inspection Center, private hospital, Community, etc, Senxu Medical AI-MA and AI-PBRTQC 2 A version of the product has been established75 Ten thousand artificial intelligence modelsandOver 100 million level real-world big dataVerification and clinical application--The readiness and specificity for identifying quality risks and error results are as high as 98%above, At present, it should beThe world's leading and largest scale!

Sen Xu AI-PBRTQC The intelligent real-time quality control platform serves as a guiding direction in the context of the challenge of centralized procurement flood "Quality Lighthouse" , Not only at the technical level, but also domestically and internationally, for chemiluminescent reagents and tumor markers IVD The production, Application and Quality Management of Clinical Laboratories in Medical Institutions, The medical safety of patients provides a solid guarantee, Also promoted at the level of ideology and practice IVD The internationalization process of the inspection industry, Ensuring the highest standards of quality and safety for clinical laboratories and patients in the context of centralized procurement. Through an international intelligent real-time quality control strategy, Optimizing Quality and Cost Balance with Intelligent Quality Control Strategy, Optimizing the quality of life with intelligent big data.


Introduction to President Cai Zongren

President of the Founding Association of Taiwan, China Medical Laboratory Management AssociationCai Zongren Associationlong

current position:

1. President of the Founding Association of Taiwan, China Medical Laboratory Management Association (2018 The society was established in September of the year)

2. ISO15189 Medical Laboratory Quality Management System Accreditation Professional Consultant (2002-to date)

3. Health management consulting services (2002-to date)

expertise:

1. medical field: Planning, operation, and automated management of the Health Management Center; Hospital establishment planning, Hospital Service Quality Management; Planning and Operation of Inspection Department, medical laboratory ISO 15189 Quality System Accreditation, LIS system integration

2. management field: ISO9001 Quality Verification, cost control, Strategy Management, marketing, Biomedical Technology Management, AI In the application of laboratory medicine. Integrated Health Management Services

3. Master's thesis: Research on the Innovative Business Model of Health Inspection Industry in Taiwan, China, China (2005)