JP2006221384A - Cultured bone production management method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To strictly relate a specimen provider with a specimen, treatment history to the specimen, and a cultured bone produced from the specimen over a long period while preventing leakage of personal information of the specimen provider. <P>SOLUTION: This cultured bone production management method comprises steps of acquiring, in a medical institution which collects the specimen for producing the cultured bone from the specimen provider, biometrics information of the specimen provider and storing the biometrics information in association with individual identification information of the specimen provider (S6); transmitting the acquired biometrics information to a cultivation institution (S7); storing the transmitted biometrics information in the cultivation institution (S9); transmitting the biometrics information with a container from the cultivation institution to the medical institution (S11); and collating, at the time of storing the specimen collected from the specimen provider in the container transmitted from the cultivation institution in the medical institution, the biometrics information attached to the container with the specimen provider. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a culture bone production management method.

  2. Description of the Related Art Conventionally, in medical institutions such as hospitals, specimens such as blood and cells, and diagnostic information of a specimen provider that provides the specimen are personal information for identifying the specimen provider, such as names, facial photographs, and unique Are managed in association with their identification numbers. On the other hand, even in research institutions that receive clinical specimens such as genetic analysis of specimens after receiving specimens and medical examination information from medical institutions, the specimens and diagnostic information received from medical institutions and their specimen providers are in some form. It is necessary to associate it.

However, when specimens and personal information are provided to research institutions as they are, it cannot be denied that the privacy and human rights of individuals may be seriously violated.
In order to solve this problem, anonymized clinical research support methods and systems have been proposed as methods for smoothly conducting clinical research in a research institution while anonymizing specimen providers and specimens (for example, patent documents). 1).

  According to this patent document 1, anonymization processing is performed on the personal information of the specimen provider and the examination information on the specimen by the anonymization system provided on the medical institution side, and the anonymized personal information and examination information are obtained from the research institution. Provided on the side. The anonymization process deletes or processes a part of the personal identification information for identifying the specimen provider such as the name, date of birth, gender, address, and telephone number of the specimen provider, This process makes it difficult to specify the sample provider.

As a result of the anonymization process, an anonymous sample number that cannot be linked to personal information is pasted to the container containing the sample and passed to the research institution unless the medical institution database is searched. Therefore, the research institution records all the clinical research results in association with the anonymous specimen number, and after returning to the medical institution, links the clinical research result and the specimen provider using the anonymous specimen number as a key. Will be able to.
Japanese Patent No. 3357039

  However, such an anonymization system is not universal, and an anonymous sample number artificially generated based on personal identification information is a unique number for each sample provider when there are multiple medical institutions. There may be cases where it does not. In addition, when the sample provider changes his / her hospital, or when the hospital from which the sample is collected disappears, there is a problem that the connection between the sample or the processing history for the sample and the sample provider is lost.

In particular, in the case of cultured bone that is manufactured in a culture institution based on a sample collected from a sample provider in a medical institution and is transplanted back to the sample provider in the medical institution again, it is manufactured from the sample provider and the sample and the sample. It is demanded that the cultured bones and the like to be strictly associated with each other over a long period of about 30 years. Therefore, the conventional anonymization system has a disadvantage that it cannot sufficiently satisfy such a request.
In addition, providing such an anonymization system on the hospital side imposes a burden on the hospital side and is not preferable.

  The present invention has been made in view of the above-mentioned circumstances, and while preventing leakage of personal information of the sample provider, the sample provider, the sample, a processing history for the sample, and a cultured bone produced from the sample, It is an object of the present invention to provide a method for managing cultured bone production that can be rigorously matched over a long period of time.

In order to achieve the above object, the present invention provides the following means.
The present invention acquires biometric information of a specimen provider in a medical institution that collects a specimen for producing cultured bone from the specimen provider, and obtains the obtained biometric information and the personal identification information of the specimen provider. A step of storing the information, a step of sending biometric information acquired at the medical institution to a culture institution that produces cultured bone based on a specimen provided from the medical institution, and a step of sending from the medical institution at the culture institution. A step of storing the obtained biometric information in a storage device, a step of sending the biometric information to a medical institution in a culture institution, and a sample collected from the specimen provider in the medical institution The biometric information attached to the container and the sample provider Providing cultured bone production management method comprising the steps of coupling.

  According to the present invention, first, biometric information is acquired from a sample provider who provides a sample in a medical institution, and is stored in association with personal identification information such as a name. Therefore, in a medical institution, it is possible to specify an individual sample provider based on biometric information.

  Next, biometric information is sent from the medical institution to the culture institution. Biometric information is unique to each individual, such as fingerprints, blood vessels, irises, retinas, palm prints, DNA, etc., and the person can be identified by searching the database using this biometric information as a key. Although it is information, it cannot identify the person directly like a name or a face photo. Therefore, even if only biometric information is distributed alone, personal information is not directly distributed.

  In the culture institution, it is possible to perform information management for identifying the specimen provider based on the sent biometric information. In this case, since the information obtained from the medical institution by the culture institution is only the biometric information, the culture institution cannot identify the specimen provider himself / herself based on the biometric information.

The biometric information sent from the medical institution is attached to the container in the culture institution. The biometric information can be attached to the container in the form of a two-dimensional identification code, for example.
The container with the biometric information is sent to the medical institution, and when the sample collected from the specimen provider is stored in the sent container, the biometric information and the specimen provider are collated. Is done. The biometric information attached to the container and the sample provider can be directly compared with each other by reading the biometric information constituting a part of the sample provider's body. Therefore, since the specimen provider itself is directly read, it is possible to more reliably prevent the container from being mixed up.

In the above invention, in the culture institution, the step of attaching the biometric information to the container containing the cultured bone manufactured using the specimen in the container sent from the medical institution and sending it to the medical institution; The method may further comprise a step of collating biometric information attached to the container with the sample provider when transplanting the cultured bone to the sample provider.
By comprising in this way, collation with the biometric information attached to the container which accommodates culture bone, and a sample provider is performed directly by reading the biometric information which constitutes a part of a sample provider's body. be able to. Therefore, since the specimen provider itself is read directly, the risk that the cultured bone is erroneously transplanted to a different specimen provider can be more reliably eliminated.

Moreover, in the said invention, it is preferable to provide the step which memorize | stores the manufacture log | history of cultured bone in relation to biometric information in a culture | cultivation organization.
By doing so, it is possible to search the stored history of cultured bone production using biometric information as a key. Therefore, even when the sample provider changes the medical institution, or even when the medical institution that collected the sample disappears due to business closure or the like, the history of the cultured bone can be searched over a long period of time.

  According to the present invention, since production management of cultured bone is performed using biometric information as a key, it is possible to prevent a mix-up in a medical institution. In addition, while preventing the personal information of the specimen provider from being leaked, the specimen provider can be strictly associated with the specimen, the processing history for the specimen, and the cultured bone produced from the specimen over a long period of time. .

A cultured bone production management method according to an embodiment of the present invention will be described below with reference to FIGS.
The cultured bone production management method according to the present embodiment is a method implemented by a medical institution such as a hospital that collects a specimen from a specimen provider and a culture institution that manufactures cultured bone based on the collected specimen.

  First, the preparation stage for producing cultured bone will be described with reference to FIG. When a patient who needs cultured bone (hereinafter referred to as a specimen provider) goes to a medical institution, personal information of the specimen provider is input to the management database A of the medical institution (step S1). The personal information includes information for identifying the sample provider such as the name, date of birth, sex, address, and telephone number of the sample provider. In addition, since a medical chart is created by a doctor's examination, the medical chart number and medical information are also registered and managed in the management database A in association with personal information. As a result of the examination, when it is determined that the production of the cultured bone is necessary, a request for manufacturing the cultured bone is transmitted from the medical institution to the culture institution (step S2).

The culture institution that has received the manufacturing request from the medical institution generates a request number and registers it in the management database B of the culture institution (step S3), and lends a reader for obtaining biometric information to the medical institution. (Step S4). The reader is preferably portable. Biometric information is information unique to each individual, such as fingerprints, blood vessels, irises, retinas, palm prints, DNA, and the like. These pieces of biometric information are information that cannot identify individual specimen providers. In the present embodiment, a fingerprint that is easy to handle will be described as an example.
Further, in the culture institution, a production schedule of cultured bone for the specimen provider is created and stored in the management database B.

  When a reader is lent from the culture institution, the medical institution performs an operation of acquiring fingerprint information, which is biometric information of the specimen provider, using the reader (step S5). The acquired fingerprint information is stored in association with personal information in the management database of the medical institution (step S6). The acquired fingerprint information is transmitted to the culture institution (step S7). The transmission method may be any method.

  When receiving the fingerprint information, the culture institution registers the received fingerprint information in the management database B in the culture institution (step S9). The fingerprint information may be used as management information as it is, but may be stored as sample provider information instead of management information, and a separate management number stored in association with the fingerprint information may be adopted as the management information. Good.

  Next, the culture institution converts the fingerprint information into a code such as a two-dimensional identification code, and pastes or prints it on a container for receiving the specimen (step S10). Containers include blood collection bags that contain blood collected for medium preparation and sampling, bone marrow containers that contain collected bone marrow fluid, and infection test containers that contain specimens such as cells collected for infection tests. Can be mentioned. A two-dimensional identification code seal for attaching fingerprint information to the chart is attached.

  The container with the fingerprint information is sent from the culture institution to the medical institution (step S11). In the medical institution, the fingerprint information attached to the sent container is read by the reader (step S12). Further, the management database in the medical institution is searched using the read fingerprint information as a key, and the corresponding chart is specified (step S12). A two-dimensional identification code seal representing fingerprint information sent from the culture institution is affixed to the identified medical chart (step S13).

In this state, in a medical institution, as long as the sample provider, the chart, and the container are related by fingerprint information that is biometric information and exist at the same place at the same time, they are directly compared without searching the database. It is possible to collate.
In addition, each process in a medical institution and culture | cultivation institution is left | separated in the management databases A and B each time.

Next, a process for collecting specimens such as blood and bone marrow fluid necessary for producing cultured bone will be described with reference to FIG.
When blood is collected from a sample provider, when the sample provider visits a medical institution, the fingerprint information of the sample provider is read at the medical institution (step S15), and a management database in the medical institution is searched using the fingerprint information as a key. The chart and the container are specified (step S16).

Since the identified chart and container are provided with the fingerprint information of the specimen provider, the specimen provider, the chart and the container can be simultaneously present at the blood collection site.
Then, the identified chart and fingerprint information of the container are read (step S17), and the specimen provider and the chart, and the specimen provider and the container are directly collated by the fingerprint information (step S18). As a result of the collation, if the fingerprint information does not match, the operation is stopped, and if the fingerprint information matches, blood is collected from the sample provider and the blood is stored in the collated container (step) S19). Thereby, the blood collected from the sample provider can be stored in the container collated with the sample provider via the fingerprint information.
Similarly, when bone marrow fluid is collected from a sample provider, the bone marrow fluid collected from the sample provider can be stored in a container that is collated with the sample provider via fingerprint information.

That is, the sample of the sample provider is not stored in the container associated by the management database A using indirect personal information such as name, identification number, medical record number, and address as a key, but directly on fingerprint information or the like. Because it is stored in a container that is collated without using the management database A by biometrics information, which is personal information, it is possible to more reliably prevent mistakes in the container due to input errors at the time of creating the database, or operator misunderstandings or misunderstandings. Can do.
In this way, a sample such as blood or bone marrow fluid stored in the container that is accurately associated with the fingerprint information is sent to the culture institution in a state of being stored in the container (step S20). Further, in the culture institution, the container is received and the carry-in history is recorded in the management database B.

Next, the process from the production of the cultured bone to the delivery to the medical institution in the culture institution will be described below with reference to FIG.
In the culture institution, the fingerprint information of the container sent is read (step S21), the management database is searched using the fingerprint information as a key, the request number is specified, and the corresponding manufacturing schedule is specified (step S22). ). And according to the specified manufacturing schedule, the manufacturing process of a cultured bone is implemented (step S23).

At this time, various events that occur during the manufacturing process of the cultured bone are recorded in the management database in association with fingerprint information as a manufacturing history. This makes it possible to search for the manufacturing history using fingerprint information as a key at a later date. Therefore, the conventional inconvenience that occurs when managed in association with the identification number provided by the medical institution, that is, when the sample provider changes the medical institution or the medical institution disappears For example, the production history of the cultured bone can be prevented from being traced, and the production history can be managed over a long period of time.
The cultured bone thus produced is stored in a delivery container with fingerprint information (step S24) and then sent to a medical institution (step S25).

  In the medical institution, the fingerprint information attached to the delivered delivery container is read (step S26), the management database is searched using the fingerprint information as a key, and the sample provider is specified (step S27).

Next, a process of transplanting cultured bone to a specimen provider in a medical institution will be described with reference to FIG.
At the time of transplantation to the specimen provider, the fingerprint information of the visited specimen provider is read by the reader (step S28), the management database in the medical institution is searched using the fingerprint information as a key, and the chart and the container with the cultured bone are specified. (Step S29).

  Then, the fingerprint information of the specified chart and the cultured bone container is read (step S30), and the specimen provider and the chart, and the specimen provider and the cultured bone container are directly collated by the fingerprint information (step S31). . Even in this case, the comparison between fingerprint information is a direct comparison not via the management database, and does not cause a mistake due to human error such as an input error.

  If the fingerprint information does not match as a result of the collation, the operation is stopped. If the fingerprint information matches, the cultured bone taken out from the collated container is transplanted to the specimen provider (step S32). ). Then, after the transplantation operation is completed, the portable reader is no longer necessary and is returned to the culture institution side (step S33).

  Thus, according to the manufacturing management method for cultured bone according to the present embodiment, it is difficult to identify the specimen provider, the chart, and various containers that contain the specimen and the cultured bone by human eyes like fingerprint information. However, by using the identification information that directly represents the sample provider, the medical institution can prevent the occurrence of a mistake due to an input error or a human error such as a misunderstanding or misunderstanding.

Also, biometric information that cannot be identified by individuals, such as fingerprint information, is handed over to the culture institution side, and the production management of the cultured bone is performed via the biometric information, so that the medical institution side can incubate The leakage of personal information to the side can be prevented.
Furthermore, on the culture institution side, by managing the production history of the cultured bone through the biometric information, the produced cultured bone and its production history can be associated with the specimen provider over a long period of time.

  In addition, according to the method for producing and managing cultured bone according to the present embodiment, a container with biometric information is created on the culture institution side and sent to the medical institution side, and the biometric information is read from the culture institution side. Since it is supposed to lend a reader that collates the two biometric information transmitted or read to the management database and return it after the completion, the medical institution side should supply the container manufacturing device or biometric information printing device or bio There exists an advantage that it can implement without providing new facilities, such as a metrics information reader.

  In the present embodiment, fingerprint information has been described as an example of biometric information for specifying a specimen provider. Instead, other biometric information, for example, iris, blood vessel, iris, retina, is used. Information such as palm prints may be employed. Biometric information that is identifiable by humans is excluded.

  In addition, in the culture institution that received the provision of biometrics information, various containers with the biometrics information were created, but in this case, so that it can be identified at a glance that it is a container for the same specimen provider, For example, the color of the identification code representing the biometric information may be different for each specimen provider.

It is a flowchart which shows the preparatory process for cultured bone manufacture among the cultured bone manufacturing management methods which concern on one Embodiment of this invention. It is a flowchart which shows a sample collection process among the cultured bone manufacturing management methods of FIG. It is a flowchart which shows the process from cultured bone manufacture to delivery among the cultured bone manufacturing management methods of FIG. It is a flowchart which shows the transplant process of the cultured bone to a sample provider among the cultured bone manufacturing management methods of FIG.

Explanation of symbols

A, B Management database (storage device)
S6 Step of storing biometric information and personal identification information in association with each other S7 Step of sending biometric information to the culture institution S9 Step of storing biometric information in the storage device S11 Sending the biometric information to the medical institution with the container Step S18 Step of collating the biometric information of the container with the specimen provider S23 Step of storing the production history of the cultured bone in association with the biometric information S25 Step of attaching the biometric information to the container containing the cultured bone and sending it to the medical institution S31 Step of collating the biometric information of the container with the sample provider

Claims (3)

In a medical institution that collects a specimen for producing cultured bone from a specimen provider, the biometric information of the specimen provider is acquired, and the acquired biometric information and the personal identification information of the specimen provider are stored in association with each other. Steps,
Sending biometric information acquired at the medical institution to the culture institution that produces the cultured bone based on the specimen provided by the medical institution;
In a culture institution, storing biometric information sent from a medical institution in a storage device;
In a culture institution, attaching biometric information to a container and sending it to a medical institution;
In a medical institution, when storing a sample collected from the sample provider in a container sent from the culture institution, a culture comprising a step of comparing biometric information attached to the container with the sample provider Bone production management method. In the culture institution, attaching the biometric information to the container containing the cultured bone manufactured using the specimen in the container sent from the medical institution and sending it to the medical institution;
The cultured bone production management method according to claim 1, further comprising: collating biometric information attached to the container with the sample provider when transplanting the cultured bone to the sample provider in a medical institution.   The cultured bone production management method according to claim 2, further comprising a step of storing the production history of the cultured bone in association with the biometric information in the culture institution.

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