System for tracking biological samples

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 method for configuring a device controlling at least one instrument in a laboratory comprising: configuring said device to store at least one item of device information, wherein the at least one item of device information is input to or generated by the device; configuring said device to store at least one item of central information wherein at least one copy of the at least one item of central information is stored in at least one other device, wherein at least one of the items of central information and device information are used by said device in connection with processing performed by said at least one instrument; configuring said device to identify a carrier in said laboratory; receiving, by a label associated with said carrier, a signal from a label scanner; and transmitting, by said label in response to said signal from said label scanner, an electromagnetic response signal including a unique identifier for uniquely identifying said carrier in said laboratory.

2. The method of claim 1, wherein said device and said at least one other device communicate with a central server to maintain an up-to-date local copy of said at least one item of central information.

3. The method of claim 2, further comprising: configuring at least one item of device information as a new item of central information; communicating said new item of central information to said central server; and configuring said at least one other device in accordance with said new item of central information using said central server.

4. The method of claim 1, wherein said device, said at least one other device and said central server are included in a laboratory network.

5. The method of claim 4, wherein said central server is connected to a laboratory information system.

6. The method of claim 1, wherein said laboratory instrument is an anatomical pathology laboratory instrument.

7. The method of claim 4, wherein said device performs offline processing with respect to said at least one other device and said central server, and said device uses said at least one item of device information in said offline processing with said at least one instrument.

8. The method of claim 7, wherein said device synchronizes said at least one item of central information with said central server when said device completes said offline processing, said device and said at least one other device being configured to use different items of central information.

9. The method of claim 1, wherein said at least one item of central information includes the unique identifier and a protocol.

10. The method of claim 1, wherein said configuring said device to identify a carrier includes using a symbology used with optical encodings in the laboratory.

11. The method of claim 10, wherein one of said instruments controlled by said device operates in accordance with said symbology.

12. The method of claim 11, wherein an optical scanner is one of said instruments controlled by said device, said scanner supporting scanning operations in accordance with said symbology.

13. The method of claim 11, wherein a printer is one of said instruments controlled by said device, said printer supporting printing operations in accordance with said symbology.

14. The method of claim 11, wherein said label is a bar code label associated with said carrier, and said symbology is used with said bar code label in connection with processing within the laboratory.

15. The method of claim 14, wherein said bar code label encodes an identifier used to obtain data from a database about said carrier associated with said bar code label, said data including at least one of said items of central information and of device information.

16. The method of claim 1, wherein said electromagnetic response signal is produced using information encoded in said label associated with said carrier.

17. The method of claim 1, further comprising: determining a location of said carrier in said laboratory in accordance with said electromagnetic response signal.

18. The method of claim 1, wherein said label is affixed to a surface of said carrier.

19. The method of claim 1, wherein said label is embedded in said carrier.

20. The method of claim 19, wherein said label includes optically recognizable data which is readable by a machine.

21. The method of claim 1, further comprising: using said unique identifier to obtain additional information about said element from a database.

22. The method of claim 1, wherein said devices, a central server, and a laboratory information system are included in a laboratory network, said laboratory information system in communication with said central server, and said central server is in communication with said device.

23. A system for laboratory information management and control comprising: a laboratory information system having patient and laboratory information, a first device configured with an item of device information and configured to share an item of central information, said item of device information being input to or generated by the device, said device using at least one of said items of central information and of device information in connection with performing processing on at least one laboratory instrument connected to said first device; said first device being further configured to identify a carrier in said laboratory, receive, by a label associated with said carrier, a signal from a label scanner, and transmit, by said label in response to said signal from said label scanner, an electromagnetic response signal including a unique identifier for uniquely identifying said carrier in said laboratory; a second device configured to share said item of central information; at least one laboratory instrument controlled by said device; and a server in communication with said laboratory information system and said at least one device, said server managing a database including said item of central information, said server communicating with said first device and said second device to maintain a current copy of said item of central information in said database, and local copies of said item of central information at each of said devices.

Description

DESCRIPTION OF DRAWINGS

(1) FIG. 1 is a diagram of an exemplary organization of one embodiment of the invention.

(2) FIG. 2 is a diagram of an exemplary architecture of one embodiment of the invention.

(3) Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

(4) In one aspect, a system for tracking the relevant samples and information is provided. It is designed to work for a single laboratory or for a network of laboratories and clients. In other aspects, the methods and apparatus for tracking samples and information are also provided. FIG. 1 shows one example of the flow of samples and information.

(5) In this example, the identifier is a printed barcode number and the sample is a tissue to be analyzed under a microscope.

(6) 1) A sample bag is received at laboratory receiving 110. The sender may have already used an accession workstation 180, to enter information into the central database 200 about the sample, such as information about the source of the sample, patient information, the tests required, and the barcode number of the bag and each sample container. The accession workstation 180 can be local or it can be at a remote location, such as in the surgery room where the sample may have been collected. Inputting information can also be done at the management workstation 120. The management workstation 120 can also allow configuration of all the instruments, as well as the laboratory information system (LIS), provide additional information or update information already in the system, and direct the processing of the sample.

(7) 2) A receiving clerk reads the bag barcode into the system. The clerk may also read the barcode on the package. This information could be linked to the delivery service so that the receipt of the package is automatically acknowledged to the delivery service. The central database finds the record of the shipment and displays a list of the expected contents for the clerk to check. If the individual samples do not have their own barcodes, the workstation can print them (as well as record the numbers).

(8) 3) At the grossing station 130, the technician shows the sample barcodes to the barcode reader and a screen displays a list of how the samples are to be divided for the requested tests. Note that no paper documentation needs to follow the sample because from the sample's unique identifier, the database can send, receive, and store the needed information. The sample may be subdivided into the needed number of vials or cassettes, as the case may be. If these vials or cassettes are prelabeled with unique barcodes, the operator shows them to the reader when he is finished to note that they are in use, otherwise the system assigns unique identifies to be affixed to the vial or cassettes. The unique identifiers can be affixed in any way known in the art, such as by affixing a label to the slide or imprinting it into the slide.

(9) 4) At the microtome 140, the same process is repeated, the operator shows the barcode of the cassette to the reader and a list appears of how many samples need to be cut for placement onto slides. Again, if the slides are not prelabeled, the station prints out the barcodes for the slides.

(10) 5) The labeled slides are loaded into an autostainer 150, which reads the barcodes and checks the central database to see what stains need to be applied to each slide.

(11) 6) Next, the slides are loaded in the automated microscope 160, which reads the barcode to see what magnification and other parameters to use to scan the slide. Automated microscopes include ACIS (automated cell image system) a device that scans the slides and presents images to the pathologist along with image processing tools to help in the diagnostic process. Apparatus for the automated analysis of samples are known in the art, for example, they are described in U.S. Pat. Nos. 6,215,892; 6,330,349; 6,418,236, the contents of which are incorporated by reference in their entirety.

(12) 7) Finally, an image is displayed to a pathologist who uses the image processing features of the review workstation 170 to study the image and arrive at a diagnosis.

(13) These diagnostic quality review workstations 170 display the images captured by the image acquisition system. In order to assist the pathologist in interpreting a medical image, a view station may be able to perform a variety of image processing operations on the medical image. For example, the pathologist at the view stations may invoke algorithms to perform densitometry on selected regions of the medical image in order to identify concentration of a particular analyte within the tissue sample. Other image processing operations are useful for finding objects within the image such as the nuclei of the cells, computing an integrated optical density for the nuclei of the cells and reporting the number of molecules per cell. Most image processing operations output a fixed number (score), often falling within a predetermined range. Demographic data about the patient, which was irrelevant to the processing of the slide, might be fetched from the central database and displayed at this point.

(14) Due to the size of some medical images for a single tissue sample, typically remote viewing is unworkable if there are bandwidth constraints. Compression algorithms can produce an image suitable for transmission, but the data lost during compression can lead to inaccurate results from the image analysis operations.

(15) A system can be utilized in which a remote review workstation 170 is communicatively coupled to an image server and receives a compressed version of a source medical image. The remote review workstation 170 can uncompress and display the received medical image. The compressed medical image can be transmitted over a global packet-switched network such as the Internet. The remote review workstation 170 can select a region of the displayed medical image as a function of input received from a user. Based on the input, the remote review workstation 170 can transmit region information, such as a series of pixel coordinates, back to the image server. The image server can then apply image analysis operations to a region of the source medical image that corresponds to the selected region of the compressed medical image. In this manner, the data loss that occurs during image compression does not affect the image analysis operations. As such, the image analysis operations can produce more accurate results than if the operations were applied by the remote review workstation 170 on the compressed image. U.S. patent application Ser. No. 09/542,091, filed Apr. 3, 2000, the contents of which are incorporated by reference, describes a system in which images are viewed at a site remote from the location of the ACIS microscope that collects the images. It further describes a method for carrying out the image processing at a remote site that has uncompressed versions of the images while transmitting compressed images for human viewing. Other means for viewing large images electronically are known to the skilled artisan. Therefore, in situations where the review workstation 170 is connected to the system with a limited bandwidth, e.g., over the WAN, one method for transmitting data involves generating a compressed medical image, transmitting the compressed medical image to a remote view station for display, selecting a region of the displayed medical image, and applying image analysis operations to a region of the source medical image corresponding to the selected region of the compressed medical imaged. The image displayed for review might be compressed, but the user's requests for image processing or scoring algorithms might be sent back to the central database for execution on uncompressed images. However, if there is no need to review the images from a remote location, e.g., over the LAN, then there is no reason not to send an uncompressed image.

(16) An optional feature of the system can include users being assigned their own identifying string, such as a barcoded badge. They can then log onto any one of the stations by scanning their barcoded badge. One method of utilizing the feature is to have the user log onto the station when they log in a slide. The system can then provide information about who has handled the slide at any given stage of its processing. This system can also be used to assess the quality and quantity of work being handled by an individual.

(17) Still other features of the system can include apparatus adapted for use in the system. For example, an autostainer may be designed to use its barcode reader to read IDs on the bottles of reagent to track which slides are stained with which lot of reagent. A scanner, such as a barcode reader, on a refrigerator or other sample storage space can be used to check in or check out samples for tracking purposes. An undedicated reader, for instance at a supervisor's station, could be used to identify a loose slide. It is contemplated that other equipment generally found in laboratories, not herein described, can also be adapted to transmit information to and/or receive information from the database to track and provide information about the sample or the process it undergoes.

(18) The system takes advantage of being able to assign unique identifiers, and utilize scanners that read them, to faithfully transmit the information to a database. Each time a slide or sample passes through some station, the database can record this event. It is, therefore, possible to provide more detailed reports and tracking information with less effort then can be done with paper based systems. For instance, if a slide is missing, the database can provide information about which station it was last logged in, when it was logged in and who logged it in, without a user having written any of this information into the system. If a batch of reagent becomes suspect, the database can provide information about all the samples that used the reagent and the test results from that use. If a stat (rush) result is needed on a sample, the database can provide in real time information about where the sample is in the process.

(19) The system may utilize a centralized database. One of the benefits of using a centralized database is that it does not matter if some steps in the processing of the sample occur at one facility and some at another. Since all the information is being stored in one database, someone accessing the database will see only the seamless processing of the sample. Furthermore, if a sample is sent from one facility to another, no paperwork need accompany it as long as the sample has its unique identifier. When the sample arrives at the new facility, its unique identifier can be scanned to log it in, to indicate its new location and when it arrived.

(20) FIG. 2 shows a block diagram of a system in which clients (who have review and accessioning workstations 310) are sending samples to reference laboratories 320 who are preparing slides and running them on an automated cell image system (ACIS). All of them are connected via the global Internet 330 to a data center 340, which is storing all the information. Table 1 shows an exemplary division of work in the application of an exemplary system.

(21) TABLE-US-00001 TABLE 1 Manual Event Automatic Event Sequence of Operation: For each Slide: Client enters accessioning info DC captures accessioning information DC sends accessioning info to RL Client sends samples DC center captures shipping DC notifies RL to expect shipment RL receives shipment DC captures receiving information RL prepares slides RL scans slides on ACIS RL ACIS sends lossless compressed images to DC RL ACIS deletes images DC sends lossy compressed images to client DC notifies Client slides are ready for review Client uses review analysis CW sends region coordinates to DC program to view slides and DC scores regions and sends scores select regions back to CW Client releases cases CW prints report DC enters billing data in database DC archives images if archive fee paid then deletes from hard disk At any time: Client requests case status on status CW queries DC and displays results display on Client workstation [if the RL had barcode readers at grossing and sectioning, the display could indicate the exact stage of each slide] Client requests re-review of CW queries DC on availability of archived case CW informs client how long tape (if they have this service) mount will take DC operator mounts tape DC sends notification to Client Client reviews case RL = CCIC reference lab 320 Client = CCIC client CW = Client's workstation 3 10 DC = CCIC data center 340

(22) Although barcodes are referred to here, any globally unique system of identifiers could be used, for instance letters and numbers if Optical Character Recognition (OCR) readers were used. An OCR system that can distinguish 80 symbols can detect 10 quintillion (a billion billion) different 10-character labels.

(23) In the system, each label is unique and is used to identify the information sent to the database and/or retrieved from the database. This allows any part of the system (within one laboratory or in other facilities) to work on the samples or slides without having to re-label for use with different equipment or for different processing steps.

(24) Other components of the system may include an autostainer and an automated microscope that reads the same barcode and each extracts the information it needs from the database; a microtome with a barcode reader and printer, which can read the barcode on a cassette (block), look up in the database what tests are to be performed on slides cut from this block, and then print the required number of slide barcodes; and/or a grossing station that can read the barcode on a sample bag and display a list of tests to be done on this sample for the guidance of the pathologist doing the grossing. It would then either print the needed barcodes for the appropriate number of cassettes or sample tubes or otherwise encode the cassettes or samples. If they were prelabled it would read the labels. In either case, it would automatically make the required entries in the database to maintain the link between the patient, sample, and the intermediate sample carriers.

(25) A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, other embodiments are within the scope of the following claims.