METHOD OF HANDLING AT LEAST ONE PATHOLOGIC SECIMEN

Abstract

The present invention relates to a method of or for handling at least one specimen. Such a specimen can be any specimen being the result of an examination and also embraces tissue samples and/or liquid biopsies. The method can comprise the steps of: providing at least one container for the specimen, transferring at least one specimen into the container, and capturing a first data set in a first station. These method steps can be performed in any order. The further step can be a generating of a transfer sheet with accumulated data on the basis of at least the first data set. The method can also comprise the delivering of the container with the specimen and the transfer sheet to a further preparing and/or analyzing stage.

Claims

1-17. (canceled)

18. A method for handling a pathologic specimen, comprising: providing a container for the pathologic specimen; transferring the pathologic specimen into the container; capturing a first data set at a first station; generating a transfer sheet based on accumulated data comprising the first data set; and delivering the container with the specimen and the transfer sheet to a pathological preparing and/or analyzing stage.

19. The method according to claim 18, further comprising capturing a container-related ID data set and accumulating the container-related data to the transfer sheet.

20. The method according to claim 19, wherein the ID data set is attached to the container, in machine-readable and/or human readable form, further comprising scanning the ID data set and then accumulating the first data set and the ID data set.

21. The method according to claim 20, wherein the ID data set attached to the container comprises a bar code and/or a data-matrix code.

22. The method according to claim 21, further comprising submitting the ID data set to a web form where the accumulated data is generated to comprise the first data set and the ID data set.

23. The method according to claim 20, further comprising: attaching the ID data set to a side and/or a bottom of the container; and/or printing the ID data set on the side and/or the bottom of the container.

24. The method according to claim 20, further comprising capturing a second data set at a second station, wherein the accumulated data comprises the first data set and/or the ID data set and the second data set.

25. The method according to claim 24, further comprising submitting and accumulating two or more of the first data set, the ID data set and the second data set to a first database (LIS) and submitting the accumulated data via an application program interface (API) to the transfer sheet.

26. The method according to claim 24, wherein the first data set comprises sample information, diagnostic information, an anatomic origin of the specimen and/or handling information, and the second data set comprises patient information and/or billing information.

27. The method according to claim 26, wherein a plurality of specimen and/or a plurality of portions of the specimen are transferred into the container and the first data set further comprises information about the number of specimen, an anatomic origin of the specimen or a kind of the specimen.

28. The method according to claim 19, wherein the ID data set comprises an ID of the container, container-batch information, and/or an intended use of the container-batch.

29. The method according to claim 18, wherein the generating the transfer sheet comprises: compiling the accumulated data set and conveying the accumulated data to a web-application, and/or transferring the accumulated data in a matrix-data-code, a barcode, a QR-code, a RFID tag, and/or an NFC tag, and/or issuing the accumulated data in machine and/or human readable form, and/or generating and conveying an access-handle to the web-application.

30. The method according to claim 18, further comprising introducing the container or a rack comprising the container and the transfer sheet into a package for the delivering.

31. The method according to claim 18, wherein the delivering the container with the specimen and the transfer sheet to the further preparing and/or analyzing stage further comprises sending at least a portion of the accumulated data of the transfer sheet to a second database (LIS) remote from the first laboratory information database (LIS).

32. The method of claim 18, wherein the pathological preparing and/or analyzing stage is used for analysis of one or more tissues and/or pathological biopsies.

33. A device, comprising: a rack configured to hold a plurality of containers; and a support for the rack, wherein the plurality of containers comprises at least one container with a specimen and a transfer sheet generated based on accumulated data comprising a first data set, captured at a first station before a pathological preparing and/or analyzing stage, and wherein the rack and/or the plurality of containers are indexed before initial use of the rack and to scan and submit the ID data set of each of the plurality of containers to a first laboratory database (LIS).

34. A transfer sheet for a container used to hold a pathologic specimen, wherein the transfer sheet is generated based on accumulated data, comprising a first data set, captured when the container including the pathologic specimen is at a first station.

Description

DRAWINGS

[0062] FIG. 1 shows an example of a container for the handling of pathologic specimen according to the present invention;

[0063] FIG. 2 exemplifies a bottom view onto a container for the handling of pathologic specimen according to the present invention;

[0064] FIG. 3 exemplifies a preferred scheme of a method for handling pathologic samples according to the present invention and

[0065] FIG. 4 depicts an embodiment of a method for handling pathologic samples according to the present invention.

BRIEF DESCRIPTIONS OF THE DRAWINGS

[0066] FIG. 1 displays part of a container 1 in accordance with an aspect of the present invention and as described above. The container can have many shapes such as brick stone shaped or cylindrical as shown. It can comprise a cassette (not shown) as it is generally used in the art. One or more cavity/cavities (not shown) can be provided in the container. The cavities can be formed by respectively shaped side walls and/or a bottom. A separation wall can keep the contained samples apart.

[0067] The cassette in the container 1 can have a box-shape or a cylindrical shape that inter alia can be used for labelling the cassette or the whole container assembly. The base of the cassette can be generally perforated with a grid in order to allow liquid to penetrate there through. The grid an extend over the whole bottom of the cassette or just a part thereof.

[0068] The container 1 can be opened by a lid 3 that can be attached to a remaining container body 2 in any form. In the embodiment shown the lid 3 can be screwed onto the remaining container body 2. The specimen can be introduced into the container 1 by opening the lid 3 and putting the specimen (not shown) in the container body 2 with an or to an already existing liquid, such as formalin.

[0069] A bottom 2a of the container body 2 can have a different shape as is sketched in the embodiment shown. Anyhow, it can have any shape and also the same shape as the body of the container.

[0070] In FIG. 1 a container ID data set 4 is shown, in the embodiment depicted in QR-code form. It can be of any other form such as human-readable or machine-readable codes. The ID data set 4 can be printed on the container 1 directly or printed on a sticker that is then attached or sticked onto the container.

[0071] FIG. 2 represents another embodiment of the container 1 and the placement of the ID data set 4 onto the bottom 2a of the container body 2. In this figure also the lid 3, the container body 2 as well as the container body bottom 2a are shown. The perspective is from the bottom side or from the bottom of FIG. 1.

[0072] This embodiment can provide the advantage that in case the container 1 is placed in a rack (not shown) together with other containers (not shown), the ID data set 4 of each container can be read out from the bottom and a respective window or transparent part (both not shown) of the rack. The respectively read out ID data set 4 can then be assigned to a respective container at that position in the rack.

[0073] FIG. 3 depicts one example of a method in accordance with the present invention. In a step S2 a first data set can be captured. This first data set can be the sample information or specimen information, the diagnostic information, the anatomic origin of the specimen or a biopsy sample by description, sketching etc., the handling information about the steps to be performed when analyzing the specimen, etc.

[0074] Another data set can be already provided or captured in step S1, as an example a second data set. This data set can be provided by another station or being captured from a database. The second data set can comprise patient related data, such as patient ID information, patient parameters, billing information, hazard information etc.

[0075] There are now depicted two potential routes of further data processing or handling. One is directly to step S5 that can be an online application or software that is called web form for the sake of brevity. This web form is able to capture either semi-automatically or automatically the data to be accumulated and to transmit it to a transfer sheet generated in step S6. The capturing in automatic fashion can mean a pulling process of all data sets by the web form in step S5. Semi-automatic can mean that the web form in step S5 is initiated and controlled by a user.

[0076] The alternative or additional route is via step S3 that can be a first database capturing the first and potentially also the second data sets and provide it via an API to the web form in step S5. In this case the first database has the function to accumulate and push the data from the upstream data sets. The first data base may also be an insurance card on which personal and/or accounting data can be stored and further can comprise specific health data.

[0077] In a step S4 the ID data set assigned to the container is provided and read out and fed to step S5. The reading out can be done by a user and preferably by a scanning of a machine-readable code, such as a QR-code. The ID data set is then joined in step S5 by the web form to the first and potentially second data sets and accumulated therewith. The ID data set can alternatively also be fed into the second data set in step S1, into the first data set in step S2 or sequentially or parallel thereto and then accumulated in step S3 and further processed.

[0078] In step S5 the transfer sheet is prepared that is provided in step S6 by printing, labeling the container etc. In step S5 a QR-code can be generated that accumulates the data sets fed in or at least relevant parts thereof. This QR-code can then be printed onto the transfer sheet to make the transfer sheet machine-readable. Alternatively, or additionally a text can be provided in step S6 and in the respectively generated transfer sheet. The transfer sheet can be any paper document or other media to transmit the accumulated data together with, in connection to or in conjunction with the container when being sent out or shipped. A special package (not shown) to join the container and the transfer sheet can also be provided as described before. Also, the containers can be shipped individually or in rack form with the respective transfer sheets.

[0079] In step S8 a device or assembly of devices can derive the specimen from the container and the data from the transfer sheet in semi-automated or fully automated manner. It can also derive any pictures etc. from the accumulated data on the transfer sheet or aside the transfer sheet.

[0080] In step S7 the accumulated data from the transfer sheet can also be extracted or scanned and fed into a second database remote from the first database. In the second database the data or at least parts thereof can be stored. The internet-based transmittal of the accumulated data can, thus, be avoided and requirements in several jurisdictions can be met while still ensuring a quick and safe procession of the data.

[0081] The data can be transmitted from the transfer sheet according to step S6 to step S7 either directly or via step S8. In step S7 also marking can be re-fed into step S8, particularly when the pathological preparation and/or storing by a cassette is done in order provide the respective data onto the cassette either directly or by a sticker or by any other media, such as an RFID or NFC medium.

[0082] In step S9 a pathologist can also interact with the steps S7 and S8. The pathologist can derive data and information and can feed it back in step S8, i.e. into the second database. Also, pictures and videos can be displayed to the pathologist in step S9 that have been gathered in the lab and transmitted, such as pictures of the anatomic origin of the specimen of a patient. The unpacking and/or preparation can be done automatically and/or independently in step S8.

[0083] FIG. 4 depicts an embodiment of a method in accordance with the present invention. The practitioner at party T2 prepares a histological specimen that has to be examined; further to the specimen itself s/he also can take a picture or a drawing, a video or a thorough description. T3, for the sake of brevity called a “transfer-sheet” requests further responses via channel A1 from the party T2 that T2 can convey to T3 via channel A2. Channels A1 and A2 can be a questionnaire, either on paper, via a dialog system like an IT-system and/or a submission of a diagnosis apparatus located at party T2.

[0084] Once all required data collected by transfer-sheet T3, a web-based application T4 receives the information conveyed by T3 via channel A5. Per back channel A6 the transfer-sheet T3 receives a status message via A6, that can comprise an acknowledgement or a fault message. The web-application or database T4 can request from IT-system T1 via channel A3 information about patient data, client data, billing data and/or further data that may be needed for further processing a sample or specimen. Channel A4 can be used to convey the requested information to the web-application T4 and further can transfer hazard information or further important, not requested information either in a formalized method or as a free text or code.

[0085] As soon as T4 has all relevant data from T1, T2 and T3, a set of data may be produced, stored and/or forwarded that can be written to a writable media along with the container with the specimen or with a cassette housing the specimen. Further to an electronically message written onto an electronically writable media like a RFID or an NFC tag, that can be of a type write once/read multiply. This method can grant a tamper proof method to allocate information to a specimen. Further, write multiply/read multiply RFID or NFC media can be used in case if data protection and privacy concerns are less relevant.

[0086] Also, a laser, an ink-jet and/or a human can write coded or plain data onto a cassette or on a sticker in a human and/or machine-readable form. Such information can, for instance, comprise a code under which the full, readable information can be retrieved from the web-application T4 and/or a laboratory information system (LIS) T5 and further to the originating party T2 or to the database associated with database T1.

[0087] LIS T5 can be adapted to communicate with the examining site T6 via channels A9 and A0 which can be a pathologist, a person specialized in histological examination, an automated apparatus that examines or compiles the diagnostic information or a combination thereof.

[0088] A0 is meant to represent the diagnosis of the specialist or a specific apparatus, who/which can access most if not all of the data in the method disclosed. A0 shall finally be transferred to party T2 and/or to database T1; further steps can be taken (and will usually be taken) by the initiating person at party T2.

[0089] T1 can be the database that is handled by the responsible party T2, such that the communication (represented by a dotted line) is self-explanatory. However, even T1 and T2 can be separated entities, wherein the party at T2 doesn't need information from database T1 directly. This is one option, if privacy or data-protection rules prohibit transfer of sensual data.

[0090] It should be noted that all information channels A1 to A9 and A0 can either be an automated transfer of information via cable, wireless network, code-driven or a combination thereof, where only codes are transferred that allow the user to retrieve the human-readable information from a display or a printout in accordance with data-protection rules. It should be understood that all transfer of information (A1-A9 and A0) can be hand-written, machine-written, electronically written and even can comprise an orally conveyed information.

[0091] Where a data transfer is referenced to be done to a LIS, it should be understood that such a transfer may be accomplished via an integration server.