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 computer program product for communicating data in a laboratory information management and control network comprising code that: receives data at a server from a single input point, said data including a first portion comprising at least one of case information, patient information and test order information, said data being entered at said single input point; stores said data in a first database managed by said server; automatically replicates said data from said first database to one or more hosts in communication with said server, a first host of said hosts controlling at least one laboratory instrument, said data being replicated without further data entry and using messages exchanged between said server and said first host; and stores said data in a second database which is local to said first host.

2. The computer program product of claim 1, wherein said single input point is a laboratory information management system managing patient and laboratory information.

3. The computer program product of claim 1, wherein said at least one laboratory instrument includes at least one of: an imager, a stainer, a bar code reader, a label printer, an optical scanner, an instrument that writes information to a label, and an instrument that reads information from a label.

4. The computer program product of claim 1, further comprising code that: receives diagnostic information from a pathologist, wherein at least a portion of said information is received using at least one of: a computer entry station, a touch pad data entry device, a voice data entry device, and an interactive video with voice data entry device.

5. The computer program product of claim 1, further comprising code that: records pathologist diagnostic information on a label associated with a sample using a data recording device in communication with one of said hosts.

6. The computer program product of claim 1, further comprising code that: exchanges communications between said server and said host to automatically maintain a synchronized copy of said data in said first database and said second database in accordance with any updates made to said data by said server, said host, or another component in communication therewith.

7. The computer program product of claim 3, wherein one of said instruments is an imager, said imager including a local memory or a data storage device upon which some of said data is stored.

8. The computer program product of claim 7, further comprising code that: produces image information using said imager; stores said image information in said one of said local memory or said data storage device; uploads said image information to said second database of said host; and automatically replicates said image information to said first database and another host by exchanging messages therebetween to maintain data synchronization of shared data elements, said image information being a shared data element.

9. The computer program product of claim 7, further comprising code that: reports, by said imager, identifying information about a sample being processed at a point in time; communicates said identifying information to said first host; and automatically replicates said identifying information to said first data and another host by exchanging messages therebetween.

10. The computer program product of claim 1, wherein said first host controls a first set of one or more laboratory instruments operating in accordance with a first set of operations, and a second host is in communication with said first host and said server and controls a second set of one or more laboratory instruments operating in accordance with a second set of operations different than the first set of laboratory instruments.

11. The computer program product of claim 8, further comprising code that stores a portion of said image information on a label associated with a sample.

12. A method for communicating data in a laboratory information management and control network comprising: receiving data at a server from a single input point, said data including a first portion comprising at least one of case information, patient information and test order information, said data being entered at said single input point; storing said data in a first database managed by said server; automatically replicating said data from said first database to one or more hosts in communication with said server, a first host of said hosts controlling at least one laboratory instrument, said data being replicated without further data entry and using messages exchanged between said server and said first host; and storing said data in a second database which is local to said first host.

13. The method of claim 12, wherein said single input point is a laboratory information management system managing patient and laboratory information.

14. The method of claim 12, wherein said at least one laboratory instrument includes at least one of: an imager, a stainer, a bar code reader, a label printer, an optical scanner, an instrument that writes information to a label, and an instrument that reads information from a label.

15. The method of claim 12, further comprising: receiving diagnostic information from a pathologist, wherein at least a portion of said information is received using at least one of: a computer entry station, a touch pad data entry device, a voice data entry device, and an interactive video with voice data entry device.

16. The method of claim 12, further comprising: recording pathologist diagnostic information on a label associated with a sample using a data recording device in communication with one of said hosts.

17. The method of claim 12, further comprising: exchanging communications between said server and said host to automatically maintain a synchronized copy of said data in said first database and said second database in accordance with any updates made to said data by said server, said host, or another component in communication therewith.

18. The method of claim 14, wherein one of said instruments is an imager, said imager including a local memory or a data storage device upon which some of said data is stored.

19. The method of claim 18, further comprising: producing image information using said imager; storing said image information in said one of said local memory or said data storage device; uploading said image information to said second database of said host; and automatically replicating said image information to said first database and another host by exchanging messages therebetween to maintain data synchronization of shared data elements, said image information being a shared data element.

20. The method of claim 12, wherein said first host controls a first set of one or more laboratory instruments operating in accordance with a first set of operations, and a second host is in communication with said first host and said server and controls a second set of one or more laboratory instruments operating in accordance with a second set of operations different than the first set of laboratory instruments.

Description

DESCRIPTION OF DRAWINGS

[0029] FIG. 1 is a diagram of an exemplary organization of one embodiment of the Invention.

[0030] FIG. 2 is a diagram of an exemplary architecture of one embodiment of the invention.

[0031] Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION

[0032] 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.

[0033] In this example, the identifier is a printed barcode number and the sample is a tissue to be analyzed under a microscope.

[0034] 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.

[0035] 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).

[0036] 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 pre labeled 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.

[0037] 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.

[0038] 5) The labeled slides are loaded into an auto stainer 150, which reads the barcodes and checks the central database to see what stains need to be applied to each slide.

[0039] 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.

[0040] 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.

[0041] 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 he fetched from the central database and displayed at this point.

[0042] 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.

[0043] 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.

[0044] 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 anyone 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.

[0045] Still other features of the system can include apparatus adapted for use in the system. For example, an auto stainer 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.

[0046] 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.

[0047] 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.

[0048] 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.

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 program to view CW sends region coordinates to DC slides and select regions DC scores regions and sends scores 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 display CW queries DC and displays results [if on Client workstation the RL had barcode readers at grossing and sectioning, the display could indicate the exact stage of each slide] Client requests re-review of archived case CW queries DC on availability of (if they have this service) CW informs client how long tape 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 310 DC = CCIC data center 340

[0049] 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.

[0050] 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.

[0051] Other components of the system may include an auto stainer 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.

[0052] 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.