Decentralized biological sample management system and method thereof

Abstract

The present invention discloses a decentralized biological sample management system and method, which relates to the field of biological sample management technology. According to the different levels involved in the biological sample management process, it is divided into a supervision layer, an execution layer, a user layer, and a knowledge layer, and different levels correspond to different functions and responsibilities and authorities. The present invention provides a comprehensive management service platform for biological sample data information exchange, resource integration, allocation, monitoring, and matchmaking, and opens up information channels between donors, scientific research units, pharmaceutical companies, storage and transportation service providers, biological sample library operators, regulatory agencies, clinical hospitals, and recipients of the entire industry chain. It solves practical problems such as low biological sample resource matching efficiency, low actual sample utilization rate, poor economic sustainability, and uneven cross-regional, cross-industry, cross-field, and cross-disciplinary cross-border resource allocation caused by information asymmetry and other factors between key nodes such as people and people, people and institutions, and institutions and institutions.

Description

Technical Field

[0001] The present invention relates to the technical field of biological sample management, and in particular to a decentralized biological sample management system and method thereof. Background Art

[0002] Biological samples refer to organs, tissues, cells, biological macromolecules, etc. from human body, other animals or plants, which are usually stored in low temperature (below -30℃) or ultra-low temperature (below -80℃) environment after collection and used as samples in scientific research. Among them, biological sample banks composed of one or several types of biological samples are important resource facilities in scientific research. For example, in molecular genetics, some research projects require a large number of genetic resource samples, so they need to use human genome libraries to complete; pathological research usually requires a large number of pathological tissue samples, so they rely on pathological sample banks.

[0003] In order to ensure the richness and diversity of biological samples, a large number of biological samples need to be preserved and managed during the establishment and subsequent maintenance of the biobank; during the operation of the biobank, sample collection and storage will usually continue, so a biobank usually has a huge number of biological samples and the number continues to increase over time.

[0004] The current situation of the biological sample bank industry is that each sample bank operates independently, lacks resource sharing, has low sample utilization, high operating costs, poor economic sustainability, and imperfect sharing and charging mechanisms. These comprehensive problems have in turn restricted the development of the industry.

[0005] According to relevant surveys, there are large regional differences in the construction of biobanks in my country. The development levels of biobanks in various regions are uneven. The databases of various biobanks exist independently, resource sharing is limited, and it is difficult to carry out regional cooperation and international exchanges, resulting in waste of biological sample resources and low sample utilization rates. The current situation of biobanks in various regions acting independently has undoubtedly increased their own operating costs. Their relatively closed operating model is like water without a source. A single source of funds makes it difficult for biobanks to operate stably and sustainably. Summary of the invention

[0006] The purpose of the present invention is to provide a decentralized biological sample management system and method thereof, integrate existing resources, mobilize all relevant parties to actively participate in the construction of a biological sample library, so as to maximize the utilization rate of biological sample resources and maximize social benefits, so as to solve practical problems such as low biological sample resource matching efficiency, low actual sample utilization rate, poor economic sustainability, and uneven cross-regional, cross-industry, cross-field, and cross-disciplinary resource allocation caused by information asymmetry between key nodes such as people and people, people and institutions, and institutions and institutions.

[0007] To this end, the present invention provides the following technical solutions:

[0008] In one aspect, the present invention provides a decentralized biological sample management system, the system comprising:

[0009] A user layer management subsystem for implementing user layer functions, wherein the user layer serves the end users of biological samples, and the user layer functions are for the end users to make demands for biological sample events, including at least one or more of: sample filing, identity verification, demand management, and case management;

[0010] An execution layer management subsystem for implementing execution layer functions, wherein the execution layer serves local execution agencies of biological samples, and the execution layer functions are for local execution agencies to execute biological sample events, including at least one or more of process management, sample management, identity authentication, project management, demand management, and order management;

[0011] A supervisory layer management subsystem for implementing supervisory layer functions, wherein the supervisory layer serves supervisory agencies of biological samples, and the supervisory layer functions are supervisory agencies supervising the execution of biological sample events, including at least one or more of compliance review, identity verification, project approval, demand review, and order approval;

[0012] The knowledge layer management subsystem realizes the knowledge layer function for users. The knowledge layer management subsystem can perform two-way data exchange with the supervision layer management subsystem and the execution layer management subsystem. The knowledge layer function is to record and publish biological sample events and information, realize the interconnection and intercommunication of the user layer, execution layer and supervision layer, and at least include: one or more of the following: recording and preservation of user identity information, recording and preservation of sample information, recording and preservation of disease research project information, recording and publication of event information chain and contribution value, and optimization suggestions for standard operating procedures.

[0013] Furthermore, the supervision layer, execution layer, user layer and knowledge layer in the system all have different participants.

[0014] Furthermore, the participants of the regulatory layer include regulatory agencies, and the regulatory agencies include at least one or more of: industry associations, health commissions, and disease control centers;

[0015] The participants of the execution layer include execution agencies, which include at least one or more of: clinical hospitals, biological sample banks, scientific research institutions, pharmaceutical companies, and cold chain logistics;

[0016] The participants in the user layer include user groups, and the user groups include at least one or more of: clinical patients, scientific researchers, clinical medical staff, pharmaceutical company representatives, voluntary donors, sample library administrators, and cold chain logistics administrators.

[0017] Furthermore, the system also includes: an Internet of Things device for biological sample management;

[0018] The IoT devices for sample management include at least one or more of: identification devices, collection devices, storage devices, logistics tools, monitoring equipment, experimental equipment, preparation tools, local network and communication equipment, and local server host devices.

[0019] In another aspect, the present invention provides a decentralized biological sample management method based on the above decentralized biological sample management system, the method comprising:

[0020] S1. Participants at the user layer or execution layer initiate valid activity events related to biological samples at the knowledge layer;

[0021] Among them, effective activities include sharing effective and verifiable clinical experience, sharing successful and replicable treatment plans, participating in research projects on specific disease topics, participating in clinical trials of new drugs, or participating in the development of special drugs for difficult diseases;

[0022] S2. The knowledge layer records the valid activity event in the form of an information chain, finds the supervision corresponding to the valid activity event according to the corresponding relationship between the valid activity event and the supervision saved on the knowledge layer, and sends the valid activity event to the supervision of the supervision layer;

[0023] When a valid activity event is recorded and published, the knowledge layer allocates contribution points to each participant of the valid activity event based on the contribution value corresponding to the valid activity event and the actual participation of the event participants; the contribution points are used as a priority reference for units or individual users to initiate new valid activity events in the future, rather than actual currency or virtual currency, that is, the higher the contribution points, the higher the priority of obtaining resources, and the greater the chance of obtaining biological sample resources;

[0024] S3. After receiving the valid activity event, the corresponding supervisor of the supervisory layer approves the valid activity event according to the authority, and allocates resources according to the contribution points allocated by the knowledge layer to each participant of the valid activity event, and returns the approval result and resource allocation result to the knowledge layer;

[0025] S4. The knowledge layer sends the approval result to the corresponding user of the user layer or the execution layer, and notifies the execution layer to call resources according to the resource allocation result;

[0026] S5. When the execution layer calls resources to execute the scenario event, it automatically matches a system node that meets all necessary conditions of the scenario event at the current stage as the management center, and allocates resources to the management center according to the scenario event attributes;

[0027] Among them, scenario events are user scenarios preset in the system based on clinical experience or actual usage needs. When the end user has a demand, the scenario event can take effect;

[0028] System nodes are the basic elements that constitute a certain scene event, including the corresponding information data packets in the system of all relevant people, things, objects or organizations involved in the scene event;

[0029] S6, the execution layer uses the allocated resources to operate and process the management center at the current stage;

[0030] S7, repeat S5 and S6 until the operations and processing of each stage of the scene event are completed;

[0031] S8. The knowledge layer records the operations and processing of the execution layer at each stage of the scenario event, realizes the digital recording and publishing of each management center, and completes the recording, publishing and preservation of valid activity events.

[0032] Furthermore, the accumulation of contribution value is based on the mortality rate of one or more specific diseases involved in the effective activities published by the World Health Organization in the previous year as an anchor reference value. If the mortality rate decreases, the percentage of decrease will be used as the base of the contribution value; if the mortality rate remains unchanged or increases, it will not be included in the contribution value.

[0033] Furthermore, the content of the information chain includes: related party information, event time and location, and node result information.

[0034] Furthermore, the contribution points are divided into personal contribution points and unit contribution points according to the organizational form; personal contribution points are used to indicate the contribution of individual users in the decentralized biological sample management system; unit contribution points are used to indicate the contribution of units or institutions in the decentralized biological sample management system; unit contribution points are accumulated through the personal contribution points of all members within the unit or institution; the accumulation of personal user contribution points is accumulated according to the actual performance of users participating in valid activity events, and the accumulation of unit or institution user contribution points is accumulated according to the actual performance of all users within the unit or institution participating in valid activity events.

[0035] Advantages and positive effects of the present invention:

[0036] The present invention provides a comprehensive management service platform for information exchange, resource integration, allocation, monitoring, and matchmaking of biological sample data, which opens up information channels between all relevant parties in the entire industry chain, including donors, scientific research institutions, pharmaceutical companies, storage and transportation service providers, biological sample library operators, regulatory agencies, clinical hospitals, and recipients, and solves practical problems such as low efficiency in biological sample resource matching, low actual sample utilization rate, poor economic sustainability, and uneven cross-regional, cross-industry, cross-field, and cross-disciplinary resource allocation caused by information asymmetry between key nodes such as people and people, people and institutions, and institutions and institutions. BRIEF DESCRIPTION OF THE DRAWINGS

[0037] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0038] Figure 1 is a functional structure diagram of a decentralized biological sample management system in an embodiment of the present invention;

[0039] Figure 2 A schematic diagram of the association relationship between the supervisory layers in an embodiment of the present invention;

[0040] Figure 3 Schematic diagram of the relationship between the supervision layer and the execution layer in an embodiment of the present invention;

[0041] Figure 4 An organizational structure diagram of a decentralized biological sample management system in an embodiment of the present invention;

[0042] Figure 5 Schematic diagram of a decentralized biological sample management method in an embodiment of the present invention. DETAILED DESCRIPTION

[0043] In order to enable those skilled in the art to better understand the scheme of the present invention, the technical scheme in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work should fall within the scope of protection of the present invention.

[0044] It should be noted that the terms "first", "second", etc. in the specification and claims of the present invention and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged where appropriate, so that the embodiments of the present invention described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions, for example, a process, method, system, product or device that includes a series of steps or units is not necessarily limited to those steps or units that are clearly listed, but may include other steps or units that are not clearly listed or inherent to these processes, methods, products or devices.

[0045] The decentralized biological sample management system and method of the present invention belong to the biological sample library industry. The specific application mode of the present invention is: according to the different levels involved in the biological sample management process, it is divided into a regulatory layer, an execution layer, a user layer, and a knowledge layer. Different levels correspond to different functions and responsibilities. The regulatory layer serves the national regulatory agency, mainly facing the regional regulatory branches, and provides authority including but not limited to project approval, resource allocation, compliance supervision, order approval, etc.; the execution layer mainly serves local executive agencies, which include but are not limited to biological sample clinical collection and application agencies, scientific research units, biological sample library operators, cold chain transportation service providers, pharmaceutical companies, etc. The execution layer provides management authority including but not limited to project management, inventory management, order management, etc.; the user layer mainly serves end users, and end users include but are not limited to donors, recipients, scientific researchers, etc. The knowledge layer is used to record and publish events and information such as scientific research results, clinical experience, donation chains and recipient chains, and establishes the value chain of the biological sample industry through the publication and recording of the aforementioned events and information.

[0046] like Figure 1 As shown, it shows a functional structure diagram of a decentralized biological sample management system in an embodiment of the present invention, the system includes: a supervision layer management subsystem facing the supervision layer, an execution layer management subsystem facing the execution layer, a user layer management subsystem facing the user layer and a knowledge layer database system; supervision layer users can manage information from other supervision users, execution layer users within the jurisdiction, and user layer users within the jurisdiction through the supervision layer management subsystem; execution layer users can manage information from other execution layer users and user layer users within the jurisdiction through the execution layer management subsystem; user layer users can manage information fed back from supervision layer users and execution layer users through the user layer management subsystem.

[0047] in:

[0048] The supervisory management subsystem for the supervisory layer is used to implement various functions of the supervisory layer, including but not limited to compliance review, identity verification, project approval, demand review, order approval and other first management services; Figure 2 As shown, the system can include multiple supervisions, and multiple supervisions belong to the same supervision layer. "Supervision" specifically refers to the actual user group of the supervision layer management subsystem, including but not limited to industry associations, health and health commissions and other institutions, and each supervision can achieve information interconnection and interoperability.

[0049] The execution layer management subsystem facing the execution layer is used to implement various functions of the execution layer. The functions of the execution layer include but are not limited to process management, sample management, identity authentication, project management, demand management, order management and other second management services; Figure 3 As shown, the system can include multiple executions, and multiple executions belong to the execution layer, and multiple executions can be supervised by the same supervisor. "Execution" specifically refers to the actual user group of the execution layer management subsystem, which can be institutional users such as biological sample banks, scientific research institutions, pharmaceutical companies, cold chain logistics, etc.

[0050] The user layer management subsystem for the user layer is used to implement various functions of the user layer. The functions of the user layer include but are not limited to sample filing, identity verification, demand management, case management and other third-party management services;

[0051] The knowledge layer database system is used to realize various functions of the knowledge layer. The functions of the knowledge layer include but are not limited to recording and saving user identity information, recording and saving sample information, recording and saving disease research project information, recording and publishing event information chain and contribution value, recording and publishing contribution score distribution, standard operating process optimization suggestions and other fourth management services.

[0052] The supervision layer, execution layer, and user layer all have different participants, including both units and organizations and users. Figure 4 As shown, it shows an organizational structure chart of a decentralized biological sample management system in an embodiment of the present invention. The organizational structure of the system includes but is not limited to regulatory departments, executive agencies, user groups, sample management-related Internet of Things devices, etc., wherein: regulatory agencies include but are not limited to industry associations, health and health commissions, disease control centers, etc.; executive agencies include but are not limited to clinical hospitals, biological sample banks, scientific research institutions, pharmaceutical companies, cold chain logistics, etc.; user groups include but are not limited to clinical patients, scientific researchers, clinical medical staff, pharmaceutical company representatives, voluntary donors, sample bank administrators, cold chain logistics administrators, etc.; sample management-related Internet of Things devices include but are not limited to identification equipment, collection equipment, storage equipment, logistics tools, monitoring equipment, experimental equipment, preparation tools and other equipment, local network and communication equipment, local server host equipment, etc.

[0053] Participants at all levels of the supervision layer, execution layer, and user layer can generate effective activity events on the knowledge layer, that is, realize the various functions of the above-mentioned knowledge layer. The knowledge layer database system records and publishes these effective activity events, and determines their contribution value to the entire biological sample management system. Then the system allocates resources to the participants at each layer according to their contribution, and realizes hierarchical management of biological samples. Through the hierarchical management of biological samples by various subsystems, the process of the biological sample management system can be controlled and the operation is efficient.

[0054] like Figure 5 As shown, it shows a flow chart of a decentralized biological sample management method based on the decentralized biological sample management system in an embodiment of the present invention, the method comprising:

[0055] S1. Users at the user layer or execution layer initiate valid activity events related to biological samples at the knowledge layer;

[0056] Among them, effective activities include but are not limited to sharing effective and verifiable clinical experience, sharing successful and replicable treatment plans, participating in research projects on specific diseases, participating in clinical trials of new drugs, participating in the development of special drugs for difficult diseases, etc.;

[0057] S2. The knowledge layer records the valid activity event in the form of an information chain and sends it to the corresponding supervisor of the supervisory layer for approval;

[0058] The content of the information chain includes but is not limited to information about related parties, event time and location, node result information, etc.;

[0059] The knowledge layer stores the correspondence between valid activity events and supervision. The knowledge layer finds the supervision corresponding to the valid activity event based on the correspondence, and then sends the valid activity event to the supervision of the supervision layer. For example, participation in a specific disease research project is approved by the National Health Commission. Another example is participation in a research and development project of an innovative drug is approved by the provincial drug supervision and administration department and the National Drug Administration.

[0060] When a valid activity event is recorded and published, the knowledge layer allocates contribution points to each participant of the valid activity event based on the contribution value corresponding to the valid activity event and the actual participation of the event participants. Contribution points are used as a priority reference for units or individual users to initiate scientific research and medical events such as project inventions, sample requirements, and matching requirements in the future, rather than actual currency or virtual currency. That is, the higher the contribution points, the higher the priority of obtaining resources and the greater the chance of obtaining biological sample resources.

[0061] Contribution points are divided into individual contribution points and unit contribution points according to the organizational form. Individual contribution points are used to indicate the contribution of individual users in the decentralized biological sample management system; unit contribution points are used to indicate the contribution of units or institutions in the decentralized biological sample management system. Unit contribution points are accumulated through the individual contribution points of all members within the unit or institution. The accumulation of individual user contribution points is based on the actual performance of users participating in valid activities, and the accumulation of unit or institution user contribution points is based on the actual performance of all users within the unit or institution participating in valid activities.

[0062] The accumulation of contribution value is based on the case fatality rate of a certain disease or diseases involved in the effective activity, as announced by the World Health Organization in the previous year. If the case fatality rate decreases, the percentage of decrease is used as the contribution value base; if the case fatality rate remains unchanged or increases, it is not included in the contribution value. For example, for effective activity events participating in leukemia research projects, the case fatality rate of leukemia announced by the World Health Organization in the previous year was 10%, and the case fatality rate of leukemia announced by the World Health Organization this year was 9%. If the initial contribution value is 1, the contribution value base corresponding to the effective activity becomes 1.1. The higher the contribution value base, the higher the contribution points generated.

[0063] The knowledge layer can be regarded as the data center of the entire biological sample management system. Through data, it forms a bridge between the user layer and the regulatory layer, and between the execution layer and the regulatory layer, to achieve the interoperability of biological sample data information, breaking the original pattern that biological sample resources can only be distributed or used within a very small range.

[0064] S3. Upon receiving the valid activity event, the corresponding supervisor of the supervisory layer will approve and allocate resources to the valid activity event, and return the approval result and resource allocation result to the knowledge layer;

[0065] In the specific implementation, the corresponding supervision of the regulatory layer approves the valid activity events according to their authority, and also allocates resources according to the contribution points assigned by the knowledge layer to each participant of the valid activity event. The greater the contribution points of the participant, the more resources can be obtained and the higher the priority of obtaining resources.

[0066] S4. The knowledge layer sends the approval result to the corresponding user of the user layer or the execution layer, and notifies the execution layer to call resources according to the resource allocation result.

[0067] S5. When the execution layer calls resources to execute the scenario event, it automatically matches a system node that meets all necessary conditions of the scenario event at the current stage as the management center, and allocates resources to the management center according to the scenario event attributes;

[0068] Among them, scenario events are user scenarios preset in the system based on clinical experience or actual usage needs. When end users have needs, scenario events can take effect.

[0069] System nodes are the basic elements that constitute a certain scene event, including the corresponding information data packets in the system for all relevant people, things, objects, organizations and other entity objects involved in the scene event.

[0070] The management center is the central node in the set of system nodes used to fully describe the effective event process in the biological sample management system. When a scene event is initiated, the system matches the management center according to the event type and matches it with relevant resources.

[0071] In different scenarios, the system node suitable for the current scenario is matched through election as the management center of the current event. Specifically, the execution layer identifies the attributes of the current node, allocates resources to it according to the scenario event, and meets the needs.

[0072] The election logic of the management center is: when a new scenario event occurs in a certain scenario, the system will automatically allocate system nodes that meet all the necessary conditions of the scenario event according to the current scenario event requirements. As the scenario event progresses, the system automatically selects management centers suitable for each stage according to the development needs of the event at different stages, and allocates resources to them. The generation logic of the nodes serving as management centers in the system is automatically selected based on specific scenario events, rather than being assigned from top to bottom through administrative level relationships in the traditional sense.

[0073] It should be noted that according to the above election logic to match the management center, the management centers corresponding to different scene events are different. At different stages of the event, the system node serving as the management center may also be different. That is, the management center is not fixed.

[0074] The execution of some complex scene events often includes multiple stages, that is, they are executed in stages, and different resources are required for each stage. In the embodiment of the present invention, in order to avoid waste of resources caused by unnecessary occupation of resources, the system nodes suitable for the current stage are automatically matched as management nodes according to the different stages of the scene events, and relevant resources are matched for them; after entering the next stage, the execution layer will automatically select the management node that matches the stage, and match relevant resources for it; that is, there will be different management nodes in different stages of the scene events, and different management nodes occupy different resources, that is, a single event occupies resources according to the stage, and part of the resources can be released after completing a stage, thereby avoiding excessive occupation of system resources by a single event and realizing the rational use of resources.

[0075] S6, the execution layer uses the allocated resources to operate and process the management center at the current stage;

[0076] S7, repeat S5 and S6 until the operations and processing of each stage of the scene event are completed;

[0077] S8. The knowledge layer records the operations and processing of the execution layer at each stage of the scenario event, realizes the digital recording and publishing of each management center, and completes the recording, publishing and preservation of valid activity events.

[0078] Among them, each relevant step in the event process depends on the scenario event. Different scenario events will have different relevant steps in the event process. For example, in the scenario event of establishing a case file for a patient in a clinical hospital scenario, the relevant steps in the event process include: the patient's attending physician enters the patient's name, gender, age, history of drug allergies, diseased part, description of the condition and other case contents into the hospital's existing management platform through inquiries, examinations and previous examination and diagnosis materials, and establishes an electronic case file for the patient through the hospital's existing management platform. For example, in the scenario event of biological sample preservation scenario, where biological samples such as diseased tissues or blood of patients need to be preserved, the relevant steps in the event process include: the biological sample information sampling personnel collect the biological samples, and the sampled biological samples are retained at a designated location, and then the person responsible for managing the biological samples at the designated location enters the biological sample information into the local biological sample management system.

[0079] In each step of the above-mentioned decentralized biological sample management method, step S1 is the release of biological sample related events, which is executed by the user layer or the execution layer, step S3 is the approval of biological sample related events, which is executed by the approval layer, steps S5-S7 are the execution of biological sample related events, which are executed by the execution layer, and the intermediate steps S2, S4, and S8 are the data connectivity of biological sample related events, which are executed by the knowledge layer. The knowledge layer realizes the interconnection and interoperability of biological sample information between the user layer, the execution layer, and the approval layer, and opens up the information channel between all relevant parties in the entire industry chain such as donors, scientific research institutions, pharmaceutical companies, storage and transportation service providers, biological sample library operators, regulatory agencies, clinical hospitals, and recipients, solving practical problems such as low efficiency of biological sample resource matching, low actual sample utilization rate, poor economic sustainability, and uneven distribution of cross-regional, cross-industry, cross-field, and cross-disciplinary resources caused by information asymmetry between key nodes such as people and people, people and institutions, and institutions and institutions.

[0080] For ease of understanding, the following is a detailed description of the management center and the system's digital recording and publishing of the management center using specific scenario event examples:

[0081] Scene event example 1:

[0082] In the clinical hospital scenario, medical records are created for patients, and their contents should include but not be limited to the patient's name, gender, age, history of drug allergies, diseased parts, description of the condition, and auxiliary diagnostic materials. At this time, the case file information data package created for the patient is the management center of the treatment event. The system allocates medical resources to the management center through the hospital's existing management platform; the system captures the traceable information of clinical treatment to realize the digital recording and release of the management center.

[0083] Scene event example 2:

[0084] In the biological sample preservation scenario, when biological samples such as diseased tissues or blood of patients need to be preserved, a biological sample information entry biological sample management system should be established before collection. Its content should include but not limited to sample code, sample name, patient information chain, collection operator information chain, collection time, preservation method, circulation code and other information. At this time, the biological sample archive information data package containing the patient information chain is the management center of this sample preservation event. The system allocates resources related to sampling and sample preservation to the management center through the existing management platform of the executive agency such as the hospital or blood station. The system realizes the digital recording and release of the management center by capturing the traceable local preservation related information.

[0085] Scene event example three:

[0086] Pharmaceutical companies need to establish disease research projects to develop new drugs for a certain disease. Project information should include but not be limited to project name, project number, information chain of the diseases involved, information chain of sample requirements, informed consent, etc. At this time, the information package containing all the information of the disease research project is the management center of this new drug development event, which is initiated, approved, and approved through the local biological sample management approval process.

[0087] The decentralized biological sample management system and method in the above-mentioned embodiment provide a comprehensive management service platform for information exchange, resource integration, allocation, monitoring, and matchmaking of biological sample data, and open up information channels between all relevant parties in the entire industry chain, such as donors, scientific research institutions, pharmaceutical companies, storage and transportation service providers, biological sample library operators, regulatory agencies, clinical hospitals, and recipients, and solve practical problems such as low efficiency in matching biological sample resources, low actual sample utilization rate, poor economic sustainability, and uneven cross-regional, cross-industry, cross-field, and cross-disciplinary resource allocation caused by information asymmetry between key nodes such as people and people, people and institutions, and institutions and institutions.

[0088] In the several embodiments provided by the present invention, it should be understood that the disclosed technical content can be implemented in other ways. Among them, the device embodiments described above are only schematic. For example, the division of the units can be a logical function division. There may be other division methods in actual implementation. For example, multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some interfaces, indirect coupling or communication connection of units or modules, which can be electrical or other forms.

[0089] The units described as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place or distributed on multiple units. Some or all of the units may be selected according to actual needs to achieve the purpose of the present embodiment.

[0090] In addition, each functional unit in each embodiment of the present invention may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit. The above-mentioned integrated unit may be implemented in the form of hardware or in the form of software functional units.

[0091] If the integrated unit is implemented in the form of a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present invention, in essence, or the part that contributes to the prior art, or all or part of the technical solution can be embodied in the form of a software product, and the computer software product is stored in a storage medium, including a number of instructions for a computer device (which can be a personal computer, a server or a network device, etc.) to perform all or part of the steps of the method described in each embodiment of the present invention. The aforementioned storage medium includes: U disk, read-only memory (ROM, Read-Only Memory), random access memory (RAM, Random Access Memory), mobile hard disk, magnetic disk or optical disk and other media that can store program codes.

[0092] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A decentralized biological sample management method, characterized in that: Applied to a decentralized biological sample management system, the system includes: a user layer management subsystem for users to implement user layer functions, the user layer serves the end users of biological samples, the user layer functions are for end users to make demands for biological sample events, including at least one or more of sample filing, identity verification, demand management, and case management; an execution layer management subsystem for implementing execution layer functions, the execution layer serves local execution agencies of biological samples, the execution layer functions are for local execution agencies to execute biological sample events, including at least one or more of process management, sample management, identity verification, project management, demand management, and order management; a supervision layer management subsystem for implementing supervision layer functions, the supervision layer serves the Regulatory agencies, the regulatory layer function is for regulatory agencies to supervise the execution of biological sample events, including at least one or more of compliance review, identity verification, project approval, demand review, and order approval; a knowledge layer management subsystem for users to implement knowledge layer functions, the knowledge layer management subsystem can perform two-way data interaction with the regulatory layer management subsystem and the execution layer management subsystem, the knowledge layer function is to record and publish biological sample events and information, and realize the interconnection and interoperability of the user layer, execution layer, and regulatory layer, including at least one or more of user identity information recording and preservation, sample information recording and preservation, disease research project information recording and preservation, event information chain and contribution value recording and publication, and standard operating process optimization suggestions; The method comprises: S1. Participants at the user layer or execution layer initiate valid activity events related to biological samples at the knowledge layer; Among them, effective activities include sharing effective and verifiable clinical experience, sharing successful and replicable treatment plans, participating in disease research projects, participating in new drug clinical trials, or participating in the development of special drugs for difficult diseases; S2. The knowledge layer records the valid activity event in the form of an information chain, finds the supervision corresponding to the valid activity event according to the corresponding relationship between the valid activity event and the supervision saved in the knowledge layer, and sends the valid activity event to the supervision of the supervision layer; When a valid activity event is recorded and published, the knowledge layer allocates contribution points to each participant of the valid activity event based on the contribution value corresponding to the valid activity event and the actual participation of the event participants; the contribution points are used as a priority reference for units or individual users to initiate new valid activity events in the future, rather than actual currency or virtual currency, that is, the higher the contribution points, the higher the priority of obtaining resources, and the greater the chance of obtaining biological sample resources; S3. After receiving the valid activity event, the corresponding supervisor of the supervisory layer approves the valid activity event according to the authority, and allocates resources according to the contribution points allocated by the knowledge layer to each participant of the valid activity event, and returns the approval result and resource allocation result to the knowledge layer; S4. The knowledge layer sends the approval result to the corresponding user of the user layer or the execution layer, and notifies the execution layer to call resources according to the resource allocation result; S5. When the execution layer makes resource calls, it automatically matches a system node that meets all conditions of the current stage of the scene event as the management center at the current stage of the scene event, and allocates resources to the management center according to the attributes of the scene event; Among them, scenario events are user scenarios preset in the system based on clinical experience or actual usage needs. When the end user has a demand, the scenario event can take effect; System nodes are the basic elements that constitute a certain scene event, including the corresponding information data packets in the system of all relevant people, things, objects or organizations involved in the scene event; S6, the execution layer uses the allocated resources to operate and process the management center at the current stage; S7, repeat S5 and S6 until the operations and processing of each stage of the scene event are completed; S8. The knowledge layer records the operations and processing of the execution layer at each stage of the scenario event, realizes the digital recording and publishing of each management center, and completes the recording, publishing and preservation of valid activity events.

2. A decentralized biological sample management method according to claim 1, characterized in that: The supervision layer, execution layer, user layer and knowledge layer in the system all have different participants.

3. A decentralized biological sample management method according to claim 2, characterized in that: Participants in the regulatory layer include regulatory agencies, which include at least one or more of: industry associations, health commissions, and disease control centers; The participants of the execution layer include execution agencies, which include at least one or more of: clinical hospitals, biological sample banks, scientific research institutions, pharmaceutical companies, and cold chain logistics; The participants in the user layer include user groups, and the user groups include at least one or more of: clinical patients, scientific researchers, clinical medical staff, pharmaceutical company representatives, voluntary donors, sample library administrators, and cold chain logistics administrators.

4. A decentralized biological sample management method according to claim 2, characterized in that: The system also includes: an Internet of Things device for biological sample management; The IoT devices for sample management include at least one or more of: identification devices, collection devices, storage devices, logistics tools, monitoring equipment, experimental equipment, preparation tools, local network and communication equipment, and local server host devices.

5. The decentralized biological sample management method according to claim 1, characterized in that: The accumulation of contribution value is based on the mortality rate of the diseases involved in the effective activities published by the World Health Organization in the previous year as an anchor reference value. If the mortality rate decreases, the percentage of decrease will be used as the base of the contribution value; if the mortality rate remains unchanged or increases, it will not be included in the contribution value.

6. The decentralized biological sample management method according to claim 1, characterized in that: The content of the information chain includes: related party information, event time and location, and node result information.

7. The decentralized biological sample management method according to claim 1, characterized in that: The contribution points are divided into individual contribution points and unit contribution points according to the organizational form; individual contribution points are used to indicate the contribution of individual users in the decentralized biological sample management system; Unit contribution points are used to indicate the contribution of a unit or institution in the decentralized biological sample management system; unit contribution points are accumulated through the individual contribution points of all members within the unit or institution; the accumulation of individual user contribution points is based on the actual performance of the user's participation in valid activity events, and the accumulation of unit or institution user contribution points is based on the actual performance of all users within the unit or institution participating in valid activity events.

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