National Healthcare Security Administration IVD The Quality Lighthouse in the Flood of Centralized Procurement: Sen Xu AI-PBRTQC

2024-05-26 3634

Image source: National Healthcare Security Administration

Notice from the National Healthcare Security Administration

5 moon 20 day, The National Healthcare Security Administration has released a heavyweight announcement "Regarding strengthening regional collaboration and doing a good job 2024 Notice on Quality Improvement and Expansion of Centralized Procurement of Pharmaceuticals in the Year" , Clarify Jiangxi's leading role in the procurement of biochemical in vitro diagnostic reagents alliance; Anhui leads the procurement of tumor markers and other in vitro diagnostic reagents alliance.

To build a broader collaborative network, The notice requires all provinces to actively participate in and conscientiously implement the centralized quantity based procurement of drugs and high-value medical consumables organized by the state, Encourage eligible provinces to upgrade their provincial alliances to national alliances, To form a unified national alliance centralized procurement system. The National Healthcare Security Administration will establish an online feedback mechanism for issues related to the implementation of centralized procurement, For enterprises with untimely and unstable supply, Handle according to the procurement tender and contract, Timely report quality issues to the local drug regulatory department and track and handle them.


Under the new situation of centralized procurement IVD The current situation and challenges faced by manufacturers

With the release of the notice from the National Healthcare Security Administration, Initiate centralized procurement of biochemical in vitro diagnostic reagents and tumor marker reagents, heralds IVD The industry will undergo significant changes. This brings opportunities for industry development to scale up, Also presents challenges, Especially higher requirements have been put forward for the quality control and inter batch stability of domestic brand reagents, Become the focus of attention.
1, The dilemma of balancing cost and quality deepens:

*Price compression and supply chain pressure: The intense bidding environment caused by centralized procurement forces IVD Reagent companies significantly reduce product prices, This directly compresses the profit margin. To maintain survival, Some companies may have to purchase raw materials, Reduce costs in production processes, Increased quality risk. Every link in the supply chain may be affected by cost pressures, From raw material suppliers to manufacturers, Go to the distributor again.

*R&D investment is limited: Long term cost compression strategies may lead to companies reducing their investment in research and development, Not only does it limit the development of new products, It also slows down the improvement and upgrading of existing products, Not conducive to the construction of long-term competitiveness of enterprises.

2, Specific manifestations of quality control bottlenecks:

*Standardization and lack of standardization: Standardization of Quality Control System for Domestic Brands, Standardization construction may be relatively lagging behind, Lack of unified quality control standards and strict enforcement, Causing significant fluctuations in product performance across different batches, Difficult to meet the consistency requirements of international standards.

*Difficulties in calibration and verification: Tumor biomarker detection requires extremely high precision, The inconsistency of calibration standards directly affects the accuracy and comparability of detection results. Lack of high-quality calibration standards and effective verification processes, It will further intensify clinical doubts about the reliability of domestic reagents.

3, The urgent need for technological upgrading:

*Core technology dependence: International brands usually have mature core technologies and patent protection, Domestic brands in antibody development, Marking technology, There may be technical blockades in terms of instrument matching and other aspects, Difficult to achieve catch-up in the short term.

*Innovation speed and conversion capability: Even with breakthroughs in new technologies, How to quickly convert it into a commercial product and ensure stable quality, This is also a major challenge faced by domestic brands. Technological innovation should not only focus on laboratory results, More consideration should be given to market adaptability, Cost effectiveness and regulatory compliance.


Quality and safety challenges faced by clinical laboratories and patients under the new situation of centralized procurement

In the specific context of the collection of chemiluminescence reagents and tumor markers, Clinical laboratories and patients may encounter the following challenges in terms of quality and safety:

1, The reliability of the test results decreases: Due to cost compression, it may sacrifice the quality of raw materials or simplify production processes, Causing unstable performance of the reagent, Enable clinical laboratories to use these reagents for tumor marker detection, May yield unreliable or inconsistent results. This directly affects the early diagnosis of the disease, Treatment monitoring and prognosis evaluation, May lead to misdiagnosis, missed diagnosis, Increasing medical risks for patients.

2, Increased difficulty in clinical decision-making: The accuracy of tumor biomarker detection results is an important basis for clinical doctors to formulate treatment plans. If the quality of the reagents is uneven, Causing significant fluctuations in the test results, Clinical doctors may find it more difficult to interpret these data, Additional checks may be required to confirm, Extended diagnosis time, Impact the timely formulation and adjustment of treatment plans.

3, Trust Crisis and Repeated Testing: Frequent inconsistent test results can damage the reputation of clinical laboratories and hospitals, Causing patients to have a negative impact on the domestic market IVD Lack of trust in reagent brands. for this, Patients may request repeat testing, Not only does it increase medical costs, It may also cause unnecessary physical burden and psychological pressure to patients due to multiple sampling.

4, Imbalance in resource allocation: If the quality of the reagent is unstable, Clinical laboratories need to invest more resources in internal quality control and validation, This may squeeze the manpower originally used for other important medical services or research projects, Material and financial resources, Affects the efficiency and effectiveness of the entire healthcare service system.

5, Compliance with regulations and liability risks: For clinical laboratories, Using unreliable reagents for testing, May violate relevant medical regulations and quality standards, Increase the legal liability risk of the laboratory, Affect its compliance management and social image.


National Healthcare Security Administration IVD The Quality Lighthouse in the Flood of Centralized Procurement: Senxu Medical AI-PBRTQC

(one) Senxu Medical AI-PBRTQC: Leading by intelligent innovation IVD The reagent industry responds to the challenges of centralized procurement

Under the wave of centralized procurement by the National Healthcare Security Administration IVD The demand for innovation in the reagent industry, Senxu Medical AI-PBRTQC The intelligent monitoring platform provides a new solution path for the industry. Senxu Medical AI-PBRTQCIntegrating artificial intelligence and precision big data analysis technology, Intended to optimize the production process, Strengthen quality control, And improve overall operational efficiency, Specifically manifested in the following aspects:

1, Intelligent optimization of cost and quality balance: Senxu MedicalAI-PBRTQC Analyzing production data through deep learning algorithms, Identify best practices for cost control and quality assurance, Assist enterprises in accurately positioning costs and reducing space, At the same time, ensure that product quality is not affected, Achieved a win-win situation of cost efficiency and quality control.

2, Refined batch management and calibration: The system can monitor the production parameters and finished product performance of each batch in real-time, Timely identify and correct inter batch differences, Ensure consistency of calibration standards, Thereby significantly improving the inter batch stability of the reagent, Enhance the reliability of clinical testing results.

3, Accelerate technological innovation and iteration: combine AI The predictive model, Senxu Medical AI-PBRTQC Ability to quickly analyze market demand and technological trends, Provide data support for the R&D team, Accelerate the development of new products and the iterative upgrade of existing products, Shorten the gap with international brands, Even surpassing in certain fields.

4, Enhance customer trust and market competitiveness: By continuously improving product quality and service, Senxu Medical AI-PBRTQC Assist enterprises in establishing a stronger brand image, Enhance medical institutions and patients' understanding of domestic products IVD Trust in reagents, Thus standing out in the fierce market competition, Especially in the centralized procurement environment, to gain more market share.

In summary, Senxu Medical AI-PBRTQC Not only for IVD The reagent industry provides an intelligent solution, Efficient solutions, To cope with the challenges brought by centralized procurement, It also promotes the development of the industry towards higher standards of quality management and technological innovation, for China IVD The transformation, upgrading, and sustainable development of enterprises have injected new impetus. In today's normalized centralized procurement, This technology driven strategy of combining quality and efficiency, Or it may lead IVD The reagent industry is entering a new stage of development.


(two) Senxu Medical AI-PBRTQC To safeguard the quality of clinical laboratories and patient medical safety

In the specific context of the collection of chemiluminescence reagents and tumor markers, Especially for the quality and inter batch stability of domestic brand reagents, Higher requirements have been put forward for inter batch differences, etc, Become the focus of attention. Sen Xu AI-PBRTQC The intelligent monitoring platform provides the following guarantees and positive effects for clinical laboratories and patients in terms of quality and safety:

1, International real-time quality control intelligent management platform: Through Senxu AI-PBRTQC The application, Real time dynamic capability, Continuous monitoring and analysis of quality risks throughout the entire process, Intelligent monitoring of different campuses, Or analyze the stability of performance using different testing systems in the same laboratory, Accuracy and consistency of inspection results, Smart Early Warning, Reduce medical risks, Realize the intelligence of quality risk management, visualization, Real time and controllability, Building internationalization, Comprehensive Quality Control and Patient Risk Management New System.

2, Monitor the inter batch differences of calibration samples: The system can accurately track the performance of calibration standards, Ensure its stability between different batches, Thus reducing detection errors caused by large inter batch differences in calibration standards, Ensuring strong comparability in clinical laboratories, Good repeatability of test results.

3, Intelligent risk management: Sen Xu AI-PBRTQC of AI Algorithms can sensitively and accurately identify and predict potential quality risks, Protecting patient medical safety.

4, Harmonious unity of cost and quality: Under the pressure of centralized procurement, AI-PBRTQC Through real-world patient big data analysis, intelligent monitoring, Realize a win-win situation between cost control and product quality, Providing cost-effective options for medical institutions, Assist in the rational allocation and sustainable development of medical resources.

5, Enhance clinical decision-making confidence: High quality test results provide accurate diagnostic basis for clinical doctors, Enhanced their confidence in developing treatment plans, Helps improve treatment effectiveness and patient prognosis, Ultimately improving the overall medical experience and health outcomes of patients.

6, Enhance patient safety and satisfaction: By ensuring high accuracy and reliability of detection, AI-PBRTQC Indirectly improved patient safety and security, Reduced secondary harm caused by misdiagnosis or missed diagnosis, At the same time, it has increased patients' satisfaction and trust in medical services.

In summary, Senxu Medical AI-PBRTQC Through its internationalization, specialization, intelligentization, lean, Visualized real-time dynamic quality management and intelligent monitoring, Not only does it provide strong technical support for clinical laboratories, Ensure the efficiency and accuracy of the testing work, It has also built a strong safety line for patients, To address the challenges of centralized procurement, An important tool for promoting both quality and cost excellence.


Billion level data! Senxu Medical AI-PBRTQC

Senxu Medical is based on AI of PBRTQC Intelligent monitoring platform (AI-PBRTQC)
Senxu Medical is based on AI Real time quality control intelligent monitoring platform for patient data (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, total100 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 As a guiding direction in the context of the challenges posed by the concentrated mining 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.


Sen Xu AI-PBRTQC Real Big Data Case Study on Identifying Quality Risks and Error Results of Centralized Procurement Reagent Consumables

Case One
Senxu Medical AI-PBRTQC Intelligent monitoring platform for sensitive and accurate identificationReplace the sample collection tube for centralized collectionSubsequently causedNSE Micro hemolysis and systematic error, The result is too high, The results of the entire batch of physical examination samples exceed the reference range.
Case 2

Senxu Medical AI-PBRTQC Intelligent monitoring platform for sensitive and accurate identificationConcentrated collection reagent creatinine Crea System error caused by residual reagent, The result is too high, The creatinine results of the entire batch of civil servants' physical examination samples exceed the reference range.
Case Three
Senxu Medical AI-PBRTQC Intelligent monitoring platform for sensitive and accurate identificationAfter the calibration of the centralized procurement reagent execution projectResulting in system errors, The result is too high, The creatinine test results of the entire batch of physical examination samples exceed the reference range.
Case Four
Senxu Medical AI-PBRTQC Intelligent monitoring platform for sensitive and accurate identificationReplace the batch number of the collected reagents with a new batch number and calibrate the calibration standardsSystem errors caused by subsequent events, The results show a positive bias. The results of the whole batch of physical examination samples for alpha fetoprotein exceed the reference range.
Case Five
Senxu Medical AI-PBRTQC Intelligent monitoring platform for sensitive and accurate identificationReplace the batch number of reagents for centralized procurement with a new batch number of reagentsSystem errors caused by subsequent events, The result shows negative bias.