WO2011144982A1

WO2011144982A1 - Method for tracking containers for biological material and marked containers

Info

Publication number: WO2011144982A1
Application number: PCT/IB2011/001011
Authority: WO
Inventors: Federica Bergamini; Alberto Battistel
Original assignee: Diapath S.P.A
Priority date: 2010-05-17
Filing date: 2011-05-12
Publication date: 2011-11-24
Also published as: ITMI20100875A1; EP2572320A1; IT1399930B1

Abstract

The invention relates to a method for tracking containers for biological material, the use of marking techniques in the method of the invention as well as the containers marked for this purpose.

Description

METHOD FOR TRACKING CONTAINERS FOR BIOLOGICAL MATERIAL

AND MARKED CONTAINERS"

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Background art

The biological samples to be examined, after having been drawn from the subject (be it a patient, a laboratory animal or a cadaver in the case of postmortem examinations) are normally identified through the application of an "abbreviation" before being processed according to the various techniques. Said abbreviation can be affixed by hand or through labelling or can be imprinted on the container.

The identification of the biological samples is necessary because said samples must be moved within the laboratories of histology, pathology or cytology, or the research or analysis facilities and, as is evident, the risk of confusion and the resulting damage especially, but not only, in the case of biological samples for diagnostic purposes, must be limited as much as possible.

In better organized facilities, like large laboratories and hospitals, such abbreviations consist of codes, for example optically-readable codes, such as the bar code or the data matrix, or they consist of electronically-readable codes, for example radio frequency identifiers (RFID from the English term Radio Frequency IDentification) that are imprinted or affixed on the containers by an operator and that are then connected to the subject from whom the sample has been drawn by electronic means.

It is apparent that every abbreviation should be such as not to cause confusion and the mixing-up of samples. However, even in the case that sophisticated codes are employed, like those mentioned above, there is always the possibility of errors being made, for example human errors since it is in any case an operator who creates and/or sets, applies or imprints said code on the container. Furthermore, other problems can derive from the breaking down of the machines responsible for the labelling, the generation of the codes or the imprinting of the codes, due to which the laboratories can find themselves in the circumstances of not being able to mark the samples to be examined.

There is thus a need to find new systems for marking and tracking the containers for hystological and/or post-mortem analysis, that are secure and prevent the possibility of generating errors, confusion and the mixing-up of samples.

Description of the invention

The aim of the present invention is to provide a method for marking and following the flow of containers for hystological and/or post-mortem analysis that obviates the drawbacks mentioned above.

Thus, according to one of its aspects, the invention is directed to a method for tracking the flow of containers for hystological and/or post-mortem analysis that comprises pre-marking said containers in the production phase with an identification code.

According to the present invention, "containers for hystological and/or postmortem analysis" is intended to mean any hystological cassette and microscope slide, usually employed in analysis laboratories, especially in hystological analysis and pathology laboratories.

According to the present invention, the terms "traceability" or "to trace" here mean the ability to mark, locate and identify the biological material in every phase of procurement, of processing, of testing and of storing, including the capability to identify the subject from whom said biological material originates; traceability furthermore implies the ability to locate and identify all relevant data relating to the products and to the materials that come into contact with such biological material.

According to the present invention, the term "to pre-mark" is intended to mean the affixing on said container of an identification code suitable for being read and recognized, and, where necessary, further processed.

"Identification code" is intended to mean a code that can be read for example optically, for example with a scanning sensor, and decoded.

Examples of such codes are bar codes, the data matrix. Alternatively, "identification code" can mean a code that can be read electronically, like for example radio frequency identifiers (RFID).

Other types of codes can in any case be used provided that they are optically/electronically processable.

According to another embodiment of the invention, "identification code" is intended to mean a code as defined above associated to the corresponding numeric code decrypted. Therefore, for example, in addition to the data matrix cells the container could show the numeric string, for example "1016- 0005".

According to a preferred embodiment of the invention, the method comprises pre-marking the containers with a code chosen between the bar code and the data matrix.

According to a particularly preferred embodiment, the invention employs the data matrix as identification code, particularly for pre-marking containers of small dimensions like slides and cassettes.

The data matrix code is indeed a reliable and very compact code that can memorize a large number of alphanumeric and alphabetic characters.

Furthermore, the data matrix is a particularly advantageous identification code because it offers the advantage of being read without errors even in case of partial damage; its correct reading is in fact normally guaranteed up to a degradation of approximately 25%.

According to another preferred embodiment of the invention, the method comprises pre-marking the containers with a code, advantageously chosen between the bar code and the data matrix, together with the corresponding numeric code.

According to a preferred embodiment, said code, advantageously either the bar code or the data matrix, is applied to the container through the use of laser or inkjet printers, according to the techniques known to those skilled in the art.

According to the method of the invention, the container for biological material can be pre-marked on any part useful for receiving the code, as shown in the figures.

The method of the invention therefore foresees that no code is to be affixed by the operator responsible for marking the container according to the invention, containing the biological material in order to render it identifiable and traceable, since said container already foresees its own "abbreviation", that is unambiguous and thus cannot be confused and advantageously not modifiable.

In other words, the method of the invention allows to provide containers that are unique and recognizable from the beginning of their production.

In this way, all that the operator needs to do is to associate the code already present on the container with the corresponding subject.

Thus, the invention also relates to a method for tracking the flow of containers for hystological and/or post-mortem analysis that comprises inserting some biological material in a container pre-marked in the production phase with an identification code as defined above, and electronically associating said pre-marked container with the subject to which said biological material belongs.

"Subject" is herein intended to mean a living being or a cadaver, human or animal. In some cases, said subject can also be of vegetal, bacterial or viral origin.

The term "to associate" intends to mean the creation of a connection, of the electronic type (for example through hardware/software systems), between the sample of biological material in the pre-marked container and the subject as defined above.

Such connection can for example be established by reading the code with an appropriate reader, associating the code with the subject as defined above and electronically storing the information relating to said association.

Naturally, said connection can be made, as mentioned, electronically, both by directly associating the identification code with the subject and, if desired or necessary, by associating the identification code with an internal code of the facility in which the container for biological material is used. It is therefore understood that thanks to the method of the invention, the risk of error is practically zero, since there is no need for the operator to write, create, set or apply any code on the container, with said container being pre- identified. ,

The advantages provided by the method of the invention are therefore evident; in particular:

- imprinters and other equipment necessary for the printing and/or for the application of the codes on the containers can be eliminated; considering that the imprinter is usually set by an operator, the possibility of human error is thus excluded; the same applies to identification through adhesive labels, that could be erroneously applied on a different container from the one foreseen;

- identification procedures are accelerated without the risk of interrupting the work in case of possible failure of the imprinters or of the printers;

- the risk of confusion is excluded in cases of homonymy, with the containers being pre-marked with unambiguous and non repeatable codes;

- the storing in third-party facilities is facilitated;

- the risk of confusion and substitution is avoided in the case of exchange of samples of biological material between different facilities (laboratories, hospitals, etc.), for example for research, consulting, etc. purposes.

According to another of its aspects, the invention has as its object a container for biological material selected from a slide and a cassette for histological and/or post-mortem analysis, pre-marked in the production phase, with an identification code.

According to a further aspect, the invention has as its object the use of an identification code as defined above for pre-marking containers for biological material, as above defined, in the production phase.

According to another of its aspects, the invention has as its object a process for the production of containers for biological material, as above defined, that comprises pre-marking said containers in the production phase.

According to a preferred embodiment, the invention has as its object a process for the production of containers for biological material, as above defined, that comprises pre-marking said containers in the production phase, wherein said containers are intended for an hystological and/or post-mortem analysis.

Brief description of the drawings

- Figure 1 is a schematic representation of a tracking for biological material pre-marked with a data matrix code.

- Figure 2 is a schematic representation of a slide for biological material pre-marked with a data matrix code and the corresponding code decrypted.

- Figure 3 shows a block diagram for the production and the use of the containers according to the invention.

With reference to the figures, Figure 1 schematically shows a cassette 10, suitable for containing and treating biological material, for example a cassette for biopsies, pre-marked with a data matrix code 20.

Figure 2 schematically shows a slide 30, suitable for the processing of biological material, pre-marked with a data matrix code 20.

With reference to Figure 3, according to the method of the invention, a container for biological material, as above defined, is produced and is pre- marked before being sold, i.e. before reaching the laboratory, hospital, etc. in which it will be used. At the moment of drawing and/or of processing of the biological material of a given subject, the operator takes the appropriate pre- marked container, inserts the biological material under examination within it, lets a suitable reader (optical, electronical, etc.) read the code affixed on said container and associates said code with the subject through a hardware/software system.

By doing so, whenever it will be necessary to verify which subject the biological material under examination belongs to, it will suffice to let a suitable reader read the code shown on the container, that is unambiguously associated with the given subject.

In the same manner, in order to find the containers containing the biological material under examination belonging to a given subject, it will suffice to retrieve from the hardware/software system the codes associated with the given subject.

Claims

I . A method for tracking the flow of containers for histological and/or post-mortem analysis, which comprises pre-marking, in the production phase, said containers with an identification code.

2. The method according to claim 1 , characterized in that said container is a histological cassette or a microscope slide.

3. The method according to claim 1 or 2, characterized in that said identification code is optically or electronically readable.

4. The method according to any one of claims 1 to 3, characterized in that said identification code is chosen among a bar code, a data matrix code and radio frequency identifier (RFID).

5. The method according to any one of the claims from 1 to 4, characterized in that said identification code also comprises the corresponding code decrypted.

6. A method for tracking the flow of containers for biological material that comprises inserting said biological material in a container pre- marked in the production phase with an identification code, and electronically associating said identification code with the subject to whom said biological material belongs.

7. The process for the production of containers for biological material that comprises pre-marking said containers in the production phase.

8. The process according to claim 7, characterized in that said container is for histological and/or post-mortem analysis.

9. A container for biological material, selected from a slide and a cassette, characterized in that said container is pre-marked, in the production phase, with an identification code.

10. The container of claim 9, characterized in that it is a cassette for histological, cytological and/or post-mortem analysis.

I I . Use of an electronically- or optically-readable identification code for pre-marking in the production phase containers for biological material.