Abstract:
A method for automatic evaluation, processing and/or testing of an anatomic pathology specimen is disclosed. The specimen is placed into a primary or secondary container labeled with a unique identification code, placed into a specimen carrier, and the carrier marked with an identification code which uniquely identifies the specimen and, by virtue of the identification code, the evaluation, processing and/or tests to be conducted thereon. The identification code may be in the form of a bar code, an RFID tag or similar device or any other identification that is either human read able, machine readable or electronically transferred. The specimen contained within the specimen container or within the specimen carrier is entered into the anatomic pathology, histology or molecular diagnostics LAS at a receiving station, which reads the identification code.

Description:
BACKGROUND OF THE INVENTION 
     The present invention relates generally to anatomic pathology, histology and molecular diagnostic laboratory automation systems, and more particularly to an improved method for automating a laboratory for the evaluation, processing and/or testing of individual surgical pathology specimens, cytology specimens, autopsy specimens, histology specimens, molecular diagnostics/genetics specimen and any other specimen or part that is submitted to the anatomic pathology laboratory or laboratories. 
     Clinical laboratory and anatomic pathology, histology and molecular diagnostic evaluation, processing and/or testing has changed and improved remarkably over the past 100 years. Initially, and anatomic pathology, histology and molecular diagnostic evaluation, processing and/or tests or assays were performed manually, and generally utilized large quantities of serum, blood, tissues or other materials/body fluids. As mechanical technology developed in the industrial work place, similar technology was introduced into the clinical laboratory. With the introduction of new technology, methodologies were also improved in an effort to improve the quality of the results produced by the individual instruments and devices, and to minimize the amount of specimen required to perform each anatomic pathology, histology and molecular diagnostic evaluation, processing and/or test. 
     More recently, instruments have been developed to increase the efficiency of evaluation, processing and/or testing procedures by reducing turn around time and decreasing the volumes of biological tissues and materials necessary to perform various evaluations and/or assays. Present directions in laboratory and anatomic pathology, histology and molecular diagnostic evaluation, processing and/or testing focus on cost containment procedures and instrumentation. Anatomic pathology, histology and molecular diagnostic laboratory automation is one area in which cost containment procedures are currently being explored and refined. Robotic engineering and specimen processing has evolved to such a degree that various types of robotic devices have been applied in the clinical laboratory and anatomic pathology, histology and molecular diagnostic settings. 
     The main focus of prior art anatomic pathology, histology and molecular diagnostic laboratory automation relies on the implementation of automated processing devices for tissue processing, staining and cover slip application to stained or processed glass slides and systems to connect the specimen handling and information needs of the anatomic pathology, histology and molecular diagnostic laboratories. Known systems in the anatomic pathology, histology and molecular diagnostic laboratory setting utilize separate automated processing devices connected by conveyor segments to move specimens from processing station to processing station. In order to obtain cost savings, the specimens are sorted manually, and grouped to be conveyed to a specific location. In this way, a carrier or person will move a group of 5-20 specimens from the processing location to the specific workstation to perform a single evaluation, process and/or test, or a battery of evaluations. Processes and/or tests, on each of the specimens delivered. 
     While grouping a plurality of specimens in a single carrier may be more cost efficient where every specimen requires only a single specific anatomic pathology, histology and molecular diagnostic test, and none of the specimens within a carrier require special priority, it is not uncommon in the hospital environment for a specimen to be subjected to a variety of different evaluations, processes and/or tests, or for a particular specimen to require a very short turn-around time (stat evaluation, processing and/or testing). In such an event, the prior art automation systems may not be effectively or efficiently utilized, and the particular specimen would have to be manually moved to various work or processing stations or locations based upon the time constraints and evaluations, processes and/or tests designated for the specimen directed by a person or group of people. 
     Another problem with prior attempts at anatomic pathology, histology and molecular diagnostic laboratory automation is in tracking the specimen and reporting the results of the specimen evaluated, processed and/or tested. Results can serve as the basis for requiring additional evaluation, processing and/or testing of a particular specimen. If the evaluation, processing and/or testing is required within a short time period, rapid and efficient reporting of results can improve patient care quality and efficiency as well as laboratory quality and efficiency. 
     SUMMARY OF THE INVENTION 
     It is a general object of the present invention to provide a method for automating an anatomic pathology, histology and molecular diagnostic laboratory which permits individual and independent assignment of a specimen, including any part or subpart thereof, to one or more of a plurality of workstations within the laboratory. 
     Another object of the present invention is to provide a method for automating an anatomic pathology, histology and molecular diagnostic clinical laboratory which can prioritize individual specimens to improve turn around time for the evaluation, processing and/or testing of an individual specimen. 
     A further object is to provide a method for automating an anatomic pathology, histology and molecular diagnostic laboratory which determines optional routing to a particular workstation, and detects any time delays because of other specimens present in a queue at a workstation. 
     An additional object is to provide a method of automating a anatomic pathology, histology and molecular diagnostic laboratory wherein the tracking and transportation are independent of the mechanism; i.e., people, automated guided vehicles and conveyor systems may be used interchangeably. 
     Still another object of the present invention is to provide a method for automating a anatomic pathology, histology and molecular diagnostic clinical laboratory which tracks a specimen location throughout the laboratory and reports evaluation, processing and/or test results to a central database for immediate review by a physician. 
     These and other objects will be apparent to those skilled in the art. 
     The method for automatic testing of an anatomic pathology, histology and molecular diagnostic laboratory specimen of the present invention includes the initial step of obtaining a specimen to be evaluated, processed and/or tested and placing the specimen into a specimen container. Information regarding the specimen and any evaluation, processing and/or testing to be conducted thereon is entered into a computerized laboratory information system (LIS), an anatomic pathology information system (APIS) or Electronic Health Record (EHR) ordering system which is connected to and communicates with any or all parts of an anatomic pathology, histology or molecular diagnostics laboratory automation system (LAS) software. The specimen container is inserted in a specimen carrier, and the carrier marked with an identification code which uniquely identifies the specimen and, by virtue of the identification code, the evaluations, processing and/or tests to be conducted thereon. The specimen contained within the specimen carrier is entered into the LAS at a receiving station, which reads the identification code and thereby determines:
         1. If evaluation, processing and/or tests which require process/steps which can run at variety of workstations;   2. If evaluation, processing and/or tests can have certain steps merged in an effort to ensure that they are carried out properly;   3. The priority of the specimen relative to other specimens already in the LAS;   4. The priority of each evaluation, processing and/or test to be conducted on the specimen; and   5. The most direct route from their receiving station to the workstation for conducting the highest priority evaluation, processing and/or test on the specimen.       

     The specimen is then entered into the LAS either by electronic registration into the system alone or by physical entry into one or more components of the automation system with electronic registration at the point of entry into the system or device. The LAS software will operate a communication and/or a control linkage to the appropriate workstation to direct the function of the evaluation, process and/or testing at the workstation. Upon directing the specimen to the appropriate workstation, the anatomic pathology, histology or molecular diagnostics LAS software recalculates the priority of all specimens in the LAS. After completion of an evaluation, process and/or test, a specimen is returned to the transport media of the LAS and directed to any subsequent workstations for other evaluation, process and/or testing, or to an archiving station for temporary or permanent storage or disposal of the specimen. 
    
    
     
       BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS 
         FIG. 1  is a flow chart showing the integration of a anatomic pathology, histology or molecular diagnostics laboratory automation system with a computerized laboratory information system (LIS), an anatomic pathology information system (APIS) or Electronic Health Record (EHR) ordering system which is connected to and communicates with any or all parts of an anatomic pathology, histology or molecular diagnostics laboratory automation system (LAS) software; 
         FIG. 2  is a schematic diagram of specimen movement through a anatomic pathology, histology or molecular diagnostics laboratory automation system; and 
         FIG. 3  is an enlarged schematic view of the specimen processing station and one workstation along the schematic of  FIG. 2 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Referring now to the drawings,  FIG. 1  is a flowchart showing how the anatomic pathology, histology or molecular diagnostics laboratory automation system (LAS) of the present invention integrates with the day-to-day operations of a hospital or health care system. Box  10  refers to any patient who is in need of examination, process and/or diagnosis. Box  12  represents the relevant physician(s) or other practitioner(s) or provider(s) who will interpret the results of the examination in order to determine the necessity of examination, process and/or tests and the priority level to be given various required examinations, processes and/or tests, in order to make a final diagnosis and/or prescribe a specified treatment. Information passes in both directions between physician/provider and patient during this episode of care. 
     As a result of the examination, the Physician/Provider will make a record of the examination results, and may enter a request for a specific evaluation, process and/or test(s) to be performed and designate the priority level of such examination, process and/or test(s). This information is entered into the computerized laboratory information system (LIS), an anatomic pathology information system (APIS) or Electronic Health Record (EHR) ordering system which is connected to and communicates with any or all parts of an anatomic pathology, histology or molecular diagnostics laboratory automation system (LAS) software shown as box  14  in the flowchart. The LIS/APIS/EMR will correlate patient information, room information, as well as any insurance or other typical general information necessary for operation of a health care system or hospital. The EMR is an information system which communicates with various information systems of the health care system to integrate all functions of the health care system/hospital. 
     Once the physician/provider&#39;s order is correlated with the patient identification information, the EMR will forward the correlated information to the laboratory information system (LIS) and/or the anatomic pathology information system (APIS) designated as box  16  in the  FIG. 1 . The LIS and/or the APIS is an information system which may be connected to the EMR to quickly and efficiently communicate information. 
     As shown in  FIG. 1 , the computerized laboratory information system (LIS), an anatomic pathology information system (APIS) or Electronic Health Record (EHR) ordering system which is connected to and communicates with any or all parts of an anatomic pathology, histology or molecular diagnostics laboratory automation system (LAS) software assigns the task of obtaining a specimen to an appropriate technician, the retrieval/reception of the specimen, being designated generally at box  18 . The physical specimen(s), sample obtained from the patient is then entered in the laboratory automation system (LAS) designated generally as box  20 . The LAS takes the place of prior art manual evaluation, processing and/or testing procedures, including the reporting of the evaluation results to the computerized laboratory information system (LIS), an anatomic pathology information system (APIS) or Electronic Health Record (EHR) ordering system. The LIS, APIS and/or EHR, communicates with the LAS to order specific evaluations, processes and/or tests related to a specific specimen, and receive the results of those evaluations. The computerized laboratory information system (LIS) or an anatomic pathology information system (APIS) may also communicate with the Electronic Health Record (EHR) to report evaluation results for accounting and insurance purposes. The computerized laboratory information system (LIS) or an anatomic pathology information system (APIS) reports either to the physician/provider via a separate workstation, or via the EHR, to report the results of the requested evaluation. 
     Referring now to  FIG. 2 , a schematic diagram of specimen/specimen carrier movement throughout the LAS is shown. The specimen arrives at a specimen receiving/accessioning station  22 , where the specimen is entered on a conveyor system designated generally at  24 . During the assignment of the task of obtaining a specimen, the computerized laboratory information system (LIS) or an anatomic pathology information system (APIS) may also provide a specimen container marked with an appropriate patient identification code. The inventor has found that a conventional bar code label applied to the specimen container is a simple and efficient method for fulfilling this function. Anatomic pathology, histology and molecular diagnostic specimen containers are not all designed for transport in a transportation mechanism therefore, a separate carrier  26  may provided to support an individual specimen container in a transportation mechanism  24 . At specimen receiving station  22 , the carrier  26  is given an identification code which correlates through the LAS software with the specimen container and the specimen to be evaluated, processed and/or tested, so that the container and carrier may be directed throughout the laboratory automation system, even when the specimen container is removed from the carrier for specific testing at a workstation (i.e. paraffin embedding workstation). 
     As shown in  FIG. 2 , transportation mechanism  24  is preferably a continuously moving transportation mechanism which will move carriers  26  in a closed loop system. At receiving station  22 , the carrier identification is entered into the LAS to determine which workstations the specimen must utilize, the order in which the stations are to be utilized, the priority of the particular evaluations, processes and/or tests to be conducted or steps to be taken, and any other pertinent information with respect to priority or turn around time. Entry of this information may be as simple as scanning the bar code or RFID tag of the specimen or carrier with the appropriate machine reader. 
     While  FIG. 2  shows only  4  specific workstations,  28 ,  30 ,  32 , and  34 , obviously a conventional anatomic pathology laboratory could have a wide variety of such stations throughout a facility. The closed loop system of the transportation mechanism  24  permits a specimen to stop at any given workstation in a predetermined geographic location. Thus, if time constraints require that the evaluation, process and/or test of workstation  34  be performed first, and that an evaluation, process and/or test of workstation  32  be performed at some time after the evaluation, process and/or test of workstation  34 , the specimen can travel on the transportation mechanism  24  past workstations  30  and  32 , directly to workstation  34 , for immediate and evaluation, processing and/or testing. Carrier  26  is then reintroduced into the transportation mechanism  24  to follow the closed loop around to the next workstation assigned to the specimen. Once the testing has been completed, the specimens are forwarded to the specimen archiving station  36  for removal from transportation mechanism  24  and appropriate storage. 
     Referring now to  FIG. 3 , an enlarged view of a portion of the schematic of  FIG. 2  is shown. Workstations  28  and  30  are shown in schematic view to demonstrate portions of the method for detecting and routing specimens at each specific workstation located along transportation mechanism  24 . As carrier  26  moves along transportation mechanism  24 , it will pass within the zone of workstation  28  where a sensor  38  will detect the identification code on carrier  26 . In the preferred embodiment of the invention, sensor  38  is a bar code reader or RFID reader while the identification code on the carrier  26  is a bar code or RFID tag. Sensor  38  is connected with the LAS, to record the movement of carrier  26 , and determine routing of the carrier. 
     A gate  40  is connected to the LAS and will be activated to redirect the movement of carrier  26  off of conveyor  24  and on to an auxiliary conveyor  42  to reach the entry point  28   a  within the workstation  28 . Testing area  28   a  may be comprised of manual testing, fully automatic mechanical testing, or partially automated testing. An additional sensor  44  is positioned along auxiliary transportation mechanism  42  to track the location of the carrier and specimen, and may be utilized to activate any automatic mechanical equipment associated with the workstation  28   a.    
     As discussed above, the software of the LAS will direct the movement of the specimen or specimen to the appropriate workstation at the appropriate time. A keyboard  46 , or the like, is provided at each workstation to enter test results into the computerized laboratory information system (LIS) or an anatomic pathology information system (APIS), which in turn distributes the appropriate instructions to the pertinent sensors and workstations, as described in more detail herein below. Once testing has been completed, the specimen or specimen is again placed in into the LAS system  24  by auxiliary transportation mechanism  42 . 
     If the particular test requested by the physician/provider is performed at workstation  30 , then the receiving station input  22  will allow the LAS software to determine the optimal route to workstation  30 , while simultaneously determining the priority of the requested evaluation, process and/or test for carrier  26  relative to other specimen carriers in the system along the transportation mechanism  24 . Sensors  38  at each gate  40  of each workstation serve to detect the relative location of the carrier as well as the states of the gate  40  of the workstation. Each sensor  44  detects the presence of a carrier at the entry point of the particular workstation, as well as the number of other carriers which are queued in line for evaluation, processing and/or testing at the particular workstation. 
     In this example, sensor  38 ′ will acknowledge the passage of carrier  26  thereby, thereby triggering the LAS to direct gate  40 ′ to divert the carrier  26  onto the auxiliary transportation system  42 ′ of workstation  30 . A sensor  34 ′ will then direct the specimen to the appropriate testing area  30   a.    
     Once the carrier has been directed into the queue of workstation  30 , the priority table of all carriers in the LAS is recalculated to again direct the next highest priority specimen along the optimal route to the requested workstation. 
     Once the test performed by workstation  30  has been completed, the results are transmitted from the work area  30   a  to the computerized laboratory information system (LIS) or an anatomic pathology information system (APIS) by virtue of keyboard  46 ′, and the specimen is loaded in the specimen carrier  26  and positioned on auxiliary transportation mechanism  42 ′. The priority of any subsequent testing is then recalculated in the LAS priority table. The specimen will then be moved to the main transportation mechanism  24  for movement to the next appropriate station. 
     Workstations  32  and  34  are not shown in detail, but include the same basic equipment as workstations  28  and  30 . Thus, a sensor  38 ′ located at workstations  32  and  34  will acknowledge passage of the specimen at that location and either direct the specimen into the workstation, or direct the specimen to continue past the workstation. If the order in which the evaluations, processes and/or tests are conducted is important, the specimen can be directed to bypass any workstation along the transportation mechanism  24  so as to immediately reach the highest priority workstation to perform the appropriate testing. Since the transportation mechanism is a closed loop, the specimen can then be moved around the loop to any other workstation. 
     Once all requested tests have been performed, the specimen will be directed into the specimen archiving station utilizing a sensor  38 ′ and gate  40 ′ in the same manner as workstations  28 ,  30 ,  32  and  34 . Since every sensor  38 ,  38 ′,  44  and  44 ′ is interconnected by way of the LAS software, the location and status of any specimen or specimen is always readily accessible by the physician/provider. Since the computerized laboratory information system (LIS), an anatomic pathology information system (APIS) or Electronic Health Record (EHR) ordering system is programmable, the physician/provider can call for additional evaluations, processes and/or tests at any time during the movement of the specimen within the LAS. This ability to direct an individual specimen to one or more of a plurality of workstations decreases the turn around time and increases the versatility of the automation system. With the use of robotics, and fully integrated laboratory instrumentation, it is possible to fully automate the process of anatomic pathology specimen handling, processing and evaluation. 
     The results of standard testing may conventionally require additional testing. In such a case, the LIS may automatically assign additional or different workstation stops based upon the results received from an evaluation, processing and/or test at any given workstation. The capability of prioritizing the evaluation, processing and/or testing also permits a physician to diagnose and/or otherwise individualize the test battery which is required for an individual patient and/or the individual patient&#39;s specimen. 
     Whereas the invention has been shown and described in connection with the preferred embodiment thereof, it will be understood that many modifications, substitutions and additions may be made which are within the intended broad scope of the appended claims. There has therefore been shown and described an improved method for automatic evaluation, processing and/or testing of an anatomic pathology, histology and molecular diagnostic specimen.