System for tracking biological samples

• US 8,676,509 B2
• Filed: 11/13/2002
• Issued: 03/18/2014
• Est. Priority Date: 11/13/2001
• Status: Active Grant

• Current Assignee: Agilent Technologies, Inc.
• Original Assignee: Dako Denmark A/S (Agilent Technologies, Inc.)
• Inventors: De La Torre-Bueno, Jose
• Primary Examiner(s): Dejong, Eric S
• Application Number:
  US10/294,996
• Publication Number:
  US 20030120633A1
• Time in Patent Office: 4,143 Days
• Field of Search: None
• US Class Current: 702/19
• CPC Class Codes: B01L 3/545 for laboratory containers
• CPC Class Codes: G01N 2035/00138 Slides
• CPC Class Codes: G01N 2035/00742 Type of codes
• CPC Class Codes: G01N 2035/00752 bar codes
• CPC Class Codes: G01N 2035/00831 identification of the sample, e.g. patient identity, place of sampling
• CPC Class Codes: G01N 2035/00841 results of the analyses
• CPC Class Codes: G01N 2035/00881 network configurations
• CPC Class Codes: G01N 2035/0091 GUI [graphical user interfaces]
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/00732 Identification of carriers, materials or components in automatic analysers
• CPC Class Codes: G01N 35/00871 Communications between instruments or with remote terminals
• CPC Class Codes: G16B 40/00 ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
• CPC Class Codes: G16B 50/00 ICT programming tools or database systems specially adapted for bioinformatics
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 30/20 for handling medical images, e.g. DICOM, HL7 or PACS
• CPC Class Codes: G16H 70/60 relating to pathologies

Abstract

Systems, methods, and apparatus are described for the handling of biological specimens for analysis. The systems, methods and apparatus are designed to reduce errors in misidentification, incorrect processing, and recordkeeping and reporting. The systems, methods, and apparatus can also provide real time tracking of samples at any stage, from collection to processing to analyzing to storage.

Claims

1. A system for tracking and processing biological tissue samples, comprising:

at least one central database configured to receive and store information relating to a biological tissue sample;

wherein the information comprises;

processing steps to be carried out on the biological tissue sample at different workstations;

last known location of the biological tissue sample;

processing history of the biological tissue sample; and

reagent lot numbers used to process the biological tissue sample;

wherein each biological tissue sample that will be processed is associated with at least one unique bar code identifier, the biological tissue samples to be processed being of unknown diagnosis,

wherein the unique bar code identifier represents a sequence of letters, numbers, symbols or combinations thereof, generated by a unique identifier algorithm or is assigned sequentially,

wherein the at least one central database is configured to communicate with a grossing workstation, the grossing station being configured to produce the biological tissue samples of unknown diagnosis, and at least one workstation chosen from shipping workstations, receiving workstations, management workstations, accessioning workstations, microtome workstations, automated stainer workstations, automated microscope workstations, and review workstations,

wherein the grossing workstation and the at least one workstation are configured to read the unique bar code identifier and to access, from the central database, workstation-specific tissue processing steps associated with the unique bar code identifier, and

a printer at the grossing workstation that is configured to automatically receive information from the central database, to automatically generate the unique bar code identifier for the biological tissue sample, and to enable the unique bar code identifier to be affixed to a tissue cassette at the grossing workstation.

2. The system of claim 1 wherein the unique identifier is a universally unique identifier (UUID) or a global unique identifier (GUID).

3. The system of claim 1 further comprising a printer at the microtome workstation, wherein the printer is configured to automatically receive information from the central database, to automatically generate the unique bar code identifier for the biological tissue sample and to enable the unique bar code identifier to be affixed to or imprinted on a microscope slide at the microtome workstation.

4. The system of claim 1 further comprising a bar code reader at the microtome workstation, wherein the bar code reader is configured to communicate with the central database and to recognize the unique bar code identifier that is prelabeled or imprinted on a microscope slide.

5. The system of claim 1 further comprising a bar code reader at the grossing workstation, wherein the bar code reader is configured to communicate with the central database and to recognize the unique bar code identifier that is prelabeled or imprinted on the tissue cassette.

6. A system for tracking and processing biological tissue samples comprising:

at least one central database configured to receive and store information relating to a biological tissue sample;

wherein the information comprises;

processing steps to be carried out on the biological tissue sample at different workstations, the processing steps being configured to prepare the biological sample for diagnosis;

last known location of the biological tissue sample;

processing history of the biological tissue sample; and

number of derived biological tissue samples to be cut from the biological tissue sample;

wherein each biological tissue sample that will be processed and each derived biological tissue sample is associated with at least one unique bar code identifier,

wherein the unique bar code identifier represents a sequence of letters, numbers, symbols or combinations thereof, generated by a unique identifier algorithm or is assigned sequentially;

a workstation for cutting the derived biological tissue samples from the biological tissue sample, wherein the workstation is configured to read the at least one unique bar code identifier and communicate with the central database, and wherein, based on the at least one unique bar code identifier, the number of derived biological tissue samples to be cut from the biological tissue sample is displayed at the workstation.

7. The system of claim 6 wherein the first workstation is a grossing workstation and the plurality of derived tissue samples is a plurality of tissue blocks to be embedded in wax.

8. The system of claim 6 wherein the first workstation is a microtome workstation and the plurality of derived tissue samples is a plurality of tissue sections to be placed on microscope slides.

9. A system for tracking and processing biological tissue samples comprising:

at least one central database configured to receive and store information relating to a biological tissue sample;

wherein the information comprises;

processing steps to be carried out on the biological tissue sample at different workstations, the processing steps being configured to prepare the biological sample for diagnosis;

last known location of the biological tissue sample;

processing history of the biological tissue sample; and

reagent lot numbers used to process the biological tissue sample;

wherein each biological tissue sample that will be processed is associated with at least one unique bar code identifier, wherein the unique bar code identifier represents a sequence of letters, numbers, symbols or combinations thereof, generated by a unique identifier algorithm or is assigned sequentially;

an automated stainer configured to communicate with the central database;

an automated slide image system configured to communicate with the central database;

a microtome workstation configured to communicate with the central database;

a first reader at the automated stainer, wherein the first reader is configured to read the unique bar code identifier, and wherein the unique bar code identifier is associated with at least one processing step for the automated stainer, and wherein the at least one processing step is displayed at the automated stainer; and

a second reader at the automated slide image system, wherein the second reader is configured to read the unique bar code identifier, and wherein the unique bar code identifier is associated with at least one processing step for the automated slide image system.

10. A system for tracking and processing biological tissue samples comprising:

at least one central database configured to receive and store information relating to a biological tissue sample;

wherein the information comprises;

processing steps to be carried out on the biological tissue sample at different workstations, the processing steps being configured to prepare the biological sample for diagnosis;

patient information;

last known location of the biological tissue sample; and

processing history of the biological tissue sample;

wherein each biological tissue sample that will be processed is associated with at least one unique bar code identifier, wherein the unique bar code identifier represents a sequence of letters, numbers, symbols or combinations thereof, generated by a unique identifier algorithm or is assigned sequentially;

wherein the at least one central database is configured to communicate with at least two workstation chosen from shipping workstations, receiving workstations, grossing workstations, management workstations, accessioning workstations;

microtome workstations, automated stainer workstations, automated microscope workstations, or review workstations;

wherein the at least one central database is configured to communicate with a laboratory information system (LIS); and

wherein at least two of the workstations are configured to read the unique bar code identifier and to access, from the central database, workstation specific processing steps associated with the unique bar code identifier.

11. The system of claim 10 wherein the central database is accessible by authorized users at remote sites.

12. The system of claim 10 wherein at least one first workstation is at a first laboratory and at least one second workstation is at a second laboratory.

13. The system of claim 10 wherein the accessioning workstation or the reviewing workstation is a remote workstation at a remote location from the central database or the other workstations.

14. The system of claim 13 wherein the remote workstation is configured to communicate with the central database via the Internet.

15. A method of tracking and processing biological tissue samples comprising:

providing at least one central database that receives and stores information relating to a biological tissue sample;

wherein the information comprises;

at least one processing step to be carried out on the biological tissue sample, the at least one processing step being configured to prepare the biological sample for diagnosis;

number of derived biological tissue samples to be cut at different workstations;

last known location of the biological tissue sample; and

processing history of the biological tissue sample;

wherein each biological tissue sample that will be processed is associated with at least one unique bar code identifier, wherein the unique bar code identifier is a sequence of letters, numbers, symbols or combinations thereof, generated by a unique identifier algorithm or is assigned sequentially and wherein the unique bar code identifier is used by the central database to access the information;

assigning, to a first tissue sample, a first unique bar code identifier, where the first unique bar code identifier is associated with the information in the central database;

providing a first workstation that recognizes the first unique bar code identifier and retrieves from the central database and displays the number of derived samples to be cut at the first workstation based on the first unique bar code identifier;

cutting derived tissue samples from at least one portion of the first tissue sample in accordance with the number of derived tissue samples to be cut at the first workstation; and

assigning a new unique bar code identifier to each derived tissue sample.

16. The method of claim 15 further comprising:

displaying, at the first workstation, the number of derived tissue samples to be cut at the first workstation.

17. The method of claim 15 further comprising:

reading at the first workstation, an operator identifier; and

associating the operator identifier with the information in the central database relating to the biological tissue sample.

18. The method of claim 15 further comprising:

placing the derived tissue samples in tissue cassettes at a grossing workstation; and

embedding the derived tissue samples in wax.

19. The method of claim 15 further comprising:

placing the derived tissue samples in microscope slides at a microtome workstation.

20. A method for tracking and processing biological tissue samples, comprising:

providing at least one central database that receives and stores information relating to a biological tissue sample,

wherein the information comprises;

tissue processing steps to be carried out on the biological tissue sample at different workstations, the processing steps being configured to prepare the biological sample for diagnosis;

last known location of the biological tissue sample;

processing history of the biological tissue sample;

reagent lot numbers used to process the biological tissue sample; and

assigning to each biological tissue sample that will be processed at least one unique bar code identifier,

wherein the unique bar code identifier represents a sequence of letters, numbers, symbols or combinations thereof, generated by a unique identifier algorithm or is assigned sequentially;

providing at least two workstations that are in communication with the at least one central database, wherein the at least two workstations are chosen from shipping workstations, receiving workstations, grossing workstations, management workstations, accessioning workstations, microtome workstations, automated stainer workstations, automated microscope workstations, or review workstations;

reading the unique bar code identifier at least two of the workstations to access workstation specific processing steps in the central database; and

displaying the tissue processing steps at one or more of the at least two workstations.

21. The method of claim 20 further comprising:

checking the database to confirm that the workstation reading the unique bar code identifier is the correct workstation to perform the next processing steps.

22. The method of claim 20 further comprising:

reading, at the first workstation, an operator identifier; and

associating the operator identifier with the information in the central database relating to the biological tissue sample.

23. The method of claim 20 further comprising:

reading the unique bar code identifier at the management workstation; and

displaying, at the management workstation, information in the central database relating to the unique bar code identifier and the biological tissue sample.

24. The method of claim 23 wherein the information is a real-time location of the biological tissue sample or a historical location of the biological tissue sample.

25. The method of claim 20 further comprising:

retrieving, from the central database, unique identifiers associated with previous biological tissue samples that have been processed with a specific reagent lot number at the stainer workstation.

26. A method of tracking and processing biological tissue, comprising:

providing at least one central database that receives and stores information relating to a biological tissue sample;

wherein the information comprises

processing steps to be carried out on the biological tissue sample, the processing steps being configured to prepare the biological sample for diagnosis;

reagent lot numbers used to process the biological tissue sample;

last known location of the biological tissue sample; and

processing history of the biological tissue sample;

wherein each biological tissue sample that will be processed comprises at least one unique bar code identifier, wherein the unique bar code identifier is a sequence of letters, numbers, symbols or combinations thereof, generated by a unique identifier algorithm or is assigned sequentially and wherein the unique bar code identifier is used by the central database to access the information;

providing, at a microtome workstation, a first reader that recognizes unique bar code identifiers and communicates with the central database through a network;

providing, at an automated stainer, a second reader that recognizes unique bar code identifiers and communicates with the central database through the network;

providing, at an automated slide image system, a third reader that recognizes unique identifiers and communicates with the central database through the network;

assigning a first unique bar code identifier to a first biological tissue sample, wherein the first biological sample is a tissue block, wherein the first unique bar code identifier is associated with the information in the central database;

recognizing the first unique bar code identifier with the first reader and accessing, in the central database, based upon first the unique bar code identifier, a first set of processing steps that comprises at least one processing step for cutting a derived tissue sample from the tissue block;

displaying the first set of processing steps at the microtome workstation;

cutting a derived tissue sample from the first tissue sample and assigning a new unique bar code identifier to the derived tissue sample;

recognizing the new unique bar code identifier with the second reader and accessing in the central database, based upon the new unique bar code identifier, a second set of processing steps that comprises at least one processing step for staining the derived tissue sample on a microscope slide;

automatically staining the derived tissue sample on the microscope slide in accordance with the second set of processing steps;

recognizing the new unique bar code identifier with the third reader and, based upon the new unique bar code identifier, accessing in the central database a third set of processing steps that comprises at least one processing step for imaging the derived tissue sample on the microscope slide; and

automatically imaging the derived tissue sample on the microscope slide in accordance with the third set of processing steps.

27. A system for tracking and processing biological tissue samples comprising:

at least one central database configured to receive and store information relating to a biological tissue sample;

wherein the information comprises;

processing steps to be carried out on the biological tissue sample at different workstations, the processing steps being configured to prepare the biological sample for diagnosis;

last known location of the biological tissue sample;

processing history of the biological tissue sample; and

reagent lot numbers used to process the biological tissue sample;

wherein each biological tissue sample that will be processed is associated with at least one unique bar code identifier, wherein the unique bar code identifier represents a sequence of letters, numbers, symbols or combinations thereof, generated by a unique identifier algorithm or is assigned sequentially;

wherein the at least one central database is configured to communicate with at least two workstations chosen from shipping workstations, receiving workstations, grossing workstations, management workstations, accessioning workstations;

microtome workstations, automated stainer workstations, automated microscope workstations, and review workstations; and

,

wherein the at least two workstations are configured to read the unique bar code identifier and to access, from the central database, workstation specific processing steps associated with the unique bar code identifier.

28. The system of claim 27 wherein the unique identifier is a universally unique identifier (UUID) or a global unique identifier (GUID).

29. The system of claim 27 further comprising a printer at the microtome workstation, wherein the printer is configured to automatically receive information from the central database, to automatically generate the unique bar code identifier for the biological tissue sample and to enable the unique bar code identifier to be affixed to or imprinted on a microscope slide at the microtome workstation.

30. The system of claim 27 further comprising a bar code reader at the microtome workstation, wherein the bar code reader is configured to communicate with the central database and to recognize the unique bar code identifier that is prelabeled or imprinted on a microscope slide.

31. The system of claim 27 further comprising a printer at the grossing workstation, wherein the printer is configured to automatically receive information from the central database, to automatically generate the unique bar code identifier for the biological tissue sample and to enable the unique bar code identifier to be affixed to a tissue cassette at the grossing workstation.

32. The system of claim 27 further comprising a bar code reader at the grossing workstation, wherein the bar code reader is configured to communicate with the central database and to recognize the unique bar code identifier that is prelabeled or imprinted on a tissue cassette.