Abstract:
A replenishment center connected to a plurality of analyzer systems each comprising at least one analyzer module which performs analysis using a replenishable item is disclosed. The replenishment center includes a receiver configured to receive operation information from at least one of the plurality of analyzer systems that relates to utilization of the replenishable item, a database configured to record the operation information in relation to the at least one of the plurality of analyzer systems, an inventory calculator configured to calculate and store in the database a remaining quantity of inventory of the replenishable item kept for the at least one of the plurality of analyzer systems, based on the operation information recorded in the database, and a suggested order generator configured to generate, when the calculated remaining quantity becomes less than a predetermined threshold, a suggested order programmed to give a user of the at least one of the plurality of analyzer systems an option of accepting or rejecting the suggested order.

Description:
BACKGROUND 
       [0001]    Medical devices and instruments such as, for example, XE-Series Automated Hematology Analyzers designed, manufactured and marketed by Sysmex Corporation®, utilize one or more reagents and other consumable or replenishable items to test and evaluate patient samples. In laboratory environments, these medical devices and instruments are utilized to process a high volume of samples received from many different sources and locations. For example, one medical device may be utilized in a hospital laboratory to process testing and samples from patients of the hospital. In another example, one or more medical devices or instruments may be utilized in an independent laboratory that receives and tests samples from numerous hospitals, clinics or other sources. In order to ensure full or optimal utilization of the medical devices, a continuous supply of the one or more reagents and other consumable or replenishable items must be available for the testing and evaluation of the patient samples of interest. 
         [0002]    U.S. Patent Application Publication No. 2002/0107642, titled “Method and Apparatus for Managing Consumer Goods Used in an Analyzer”. The application discloses a method and apparatus which manage consumer goods used in an analyzer and prevent order loss from occurring due to an analyzer user&#39;s human error. In the method, consumption status of consumer goods consumed by an analyzer is monitored and analyzed according to consumer goods in which said consumer goods suppliers deal. The analyzed consumer goods consumption status and supply management information are transmitted to a management unit for the analyzer, consumer goods suppliers&#39; supply management units or a supply management unit for a consumer goods vendor. Supply status is confirmed based on the consumer goods supply management information. Payment is requested from an analyzer administrator, consumer goods suppliers or a consumer goods vendor in consideration of use of the information based on said step that monitors consumer goods consumption status and said step that analyzes the consumer goods consumption status. 
         [0003]    U.S. Patent Application Publication No. 2009/00134978, titled “Stock Article Management System”. The application discloses that an automatic analyzer transmits information about stock articles used in automatic analyzers provided in a plurality of facilities, respectively, to a management station through a network. The management station manages the stock articles in the plurality of facilities. Each facility includes an information exchanger on which stock articles each appended with an RFID tag are arranged; a first reader/writer exchanging, with the RFID tag, information about the stock articles, when the stock articles are arranged on the information exchanger; a second reader/writer provided in the automatic analyzer, wherein the second reader/writer exchanges, with the RFID tag, information about the stock articles, shares, with the first reader/writer, the information about the stock articles, when the stock articles are mounted on the automatic analyzer; and a processor that processes the information about the stock articles. The management station collectively manages in real time the stock articles in the facilities. 
         [0004]    Japanese Patent Application Publication No. 2003-248005 discloses an analyzer that sends reagent information to a reagent supplier via a network. The reagent supplier prepares and sends a reagent shipping list, based on the received reagent information. 
         [0005]    Japanese Patent Application Publication No. 2002-350451 discloses an analyzer that sends reagent information to a reagent supplier via a network. Based on the received reagent information, the reagent supplier predicts future consumption of reagents by a user and sends an order to its reagent vender, based on the prediction. 
         [0006]    In each of the above-identified U.S. and Japanese patent records, the user of the system or device has no control over the ordering of reagent supplies. 
         [0007]    It would be desirable to improve on each of these known systems and methods to decrease the monitoring and management activities necessary to efficiently utilize the medical devices and instruments and manage the one or more reagents, consumables or replenishable items. Moreover, it would be desirable to streamline the management and replenishment of the one or more reagents and other consumable or replenishable items. 
       SUMMARY 
       [0008]    The disclosed system, apparatus and method relates to an auto-replenishment system that provides a mechanism by which medical devices may be configured to monitor, communicate and automatically reorder one or more reagents and other consumable or replenishable items. 
         [0009]    In an embodiment, a replenishment center connected to a plurality of analyzer systems each comprising at least one analyzer module which performs analysis using a replenishable item is disclosed. The replenishment center includes a receiver configured to receive operation information from at least one of the plurality of analyzer systems, wherein the operation information relates to utilization of the replenishable item, a database configured to record the operation information in relation to the at least one of the plurality of analyzer systems, an inventory calculator configured to calculate and store in the database a remaining quantity of inventory of the replenishable item kept for the at least one of the plurality of analyzer systems, based on the operation information recorded in the database, and a suggested order generator configured to generate, when the calculated remaining quantity becomes less than a predetermined threshold, a suggested order programmed to give a user of the at least one of the plurality of analyzer systems an option of accepting or rejecting the suggested order. 
         [0010]    In another embodiment, a method for soliciting an order of a replenishable item from a plurality of analyzer systems each comprising at least one analyzer module which performs analysis using the replenishable item is disclosed. The method includes receiving operation information from at least one of the plurality of analyzer systems which relates to consumption of the replenishable item, recording in a database the operation information in relation to the at least one of the plurality of analyzer systems, calculating and store in the database a remaining quantity of inventory of the replenishable item kept for the plurality of analyzer systems, based on the operation information recorded in the database, and generating, when the calculated remaining quantity becomes less than a predetermined threshold, a suggested order programmed to give a user of the analyzer system an option of accepting or rejecting the suggested order. 
         [0011]    In another embodiment, an analyzer system is disclosed. The analyzer includes an analysis module utilizing a replenishable item to analyze a sample, a tracking module configured to monitor analysis operations of the analysis module and create operation information indicative of the analysis operations of the analysis module, wherein the operation information relates to consumption of the replenishable item, a transmitter configured to transmit the operation information to a replenishment center, and an order presenter configured to present a suggested order in such a way as to give a user of the system an option of accepting or rejecting the suggested order. 
         [0012]    In another embodiment, a method for giving a user of an analyzer system an option on an order for a replenishable item used in the analyzer system is disclosed. The method includes utilizing the replenishable item during the analysis of a sample, monitoring analysis operations and creating operation information indicative of the analysis operations, wherein the operation information relates to consumption of the replenishable item, transmitting the operation information to a replenishment center, receiving a suggested order for ordering the replenishable item from the replenishment center, and providing the received suggested order to the user of the analyzer system with an option of accepting or rejecting the suggested order. 
         [0013]    In another embodiment, a system for auto-replenishment and monitoring is disclosed. The system includes an analyzer system disposed at a first location and connected to a network, wherein the analyzer system further includes an analysis module using a replenishable item to analyze a sample, a tracking module configured to monitor analysis operations of the analysis module and create operation information indicative of the analysis operations of the analysis module, wherein the operation information relates to consumption of the replenishable item, and a transmitter configured to transmit the operation information to a network. The system further includes a replenishment center disposed at a second location and connected to the network, wherein the replenishment center includes a receiver configured to receive operation information from an analyzer system which relates to consumption of the replenishable item, a database configured to record the operation information in relation to the at least one analyzer system, an inventory calculator configured to calculate and store in the database a remaining quantity of inventory of the replenishable item kept for the analyzer system, based on the operation information recorded in the database, and a suggested order generator configured to generate, when the calculated remaining quantity becomes less than a predetermined threshold, a suggested order programmed to give a user of the analyzer system an option of accepting or rejecting the suggested order. 
         [0014]    Other embodiments are disclosed, and each of the embodiments can be used alone or together in combination. Additional features and advantages of the disclosed embodiments are described in, and will be apparent from, the following Detailed Description and the figures. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0015]      FIG. 1  illustrates an embodiment of a system for auto-replenishment and monitoring as disclosed herein; 
           [0016]      FIG. 2  illustrates a block diagram representative of a medical device configured according to the disclosure provided herein; 
           [0017]      FIG. 3  illustrated a block diagram representative of a replenishment center configured according to the disclosure provided herein; 
           [0018]      FIG. 4  illustrates an embodiment of a multi-site system for auto-replenishment and monitoring as disclosed herein; 
           [0019]      FIG. 5  illustrates another embodiment of the multi-site system for auto-replenishment and monitoring shown in  FIG. 4 ; 
           [0020]      FIG. 6A  illustrates an operational flowchart of a medical device configured for operation in an auto-replenishment system; 
           [0021]      FIG. 6B  illustrates an operational flowchart detailing an information update between a medical device and an auto-replenishment center; 
           [0022]      FIGS. 6C and 6D  illustrate replenishment and monitoring operational flowcharts that may be utilized in connection with an exemplary auto-replenishment system; and 
           [0023]      FIGS. 7A to 7E  illustrate exemplary interface screens that may be utilized in connection with an exemplary auto-replenishment and monitoring system. 
       
    
    
     DETAILED DESCRIPTION 
       [0024]    The system, apparatus and method disclosed herein are configured to provide an efficient process by which by which medical devices may be configured to monitor, communicate and automatically reorder one or more reagents and other consumable or replenishable items. In particular, the disclosure provides an efficient ordering process, a way to manage a customer or user&#39;s on-site inventory of reagents, consumables and other replenishable items, and reduces or eliminates the need for expedited shipping reagents, consumables and other replenishable items to may arise from the inefficient inventory control mechanisms utilized in known/current asset management systems. 
         [0025]    In order to maximize the utilization and throughput of medical devices such as a hematology device or other blood analysis equipment, a constant, available supply of reagents and other consumable or replenishable items must be ensured. If a customer or other user of, for example, a hematology device insufficiently stocks or otherwise runs out of reagents or other consumable materials, the medical device can be rendered non-functional until replacements can be procured. Rush procurement of reagents and other consumable or replenishable items can be a costly and time-consuming endeavor. Moreover, reagents and other consumable materials used for analysis in medical devices are often viable for limited periods. Large inventories of reagents and other consumable or replenishable materials may result in waste and disposal of unused inventories after their expiration dates. Customers or other users of the exemplary medical devices such as a hematology device or other blood analysis equipment often lack the personnel, inventory tracking resources and/or system monitoring tools to detect and address when a low inventory situation is about to occur. The disclosed system, apparatus and method addresses the shortcoming noted above and provides numerous additional benefits. 
         [0026]    Additional benefits realized by the disclosed system, apparatus and method include an ability to: accurately deduce replenishable item usage patterns; forecast replenishable item production requirements based on usage patterns; reduce shipping costs associated with expedited shipping and processing of replenishable items; reduce inventory management costs; and improve or enhance the overall utilization or “up-time” of the medical devices being monitored. 
         [0027]    In one embodiment, the disclosed system, apparatus and method may be configured to track and determine, based on medical device identifier such as a machine or model serial number, a number of reagent or consumable cycles, reagent or consumable container usage, a correlation between reagent or consumable cycles and reagent or consumable container usage, and identify the reagent or consumable products or items depleted and necessary to continued efficient operation of the medical device and/r hematology device. The gathered information may, in turn, be communicated via the medical device and/or hematology device to a replenishment center for order and fulfillment of the depleted reagent or consumable items. 
         [0028]      FIG. 1  illustrates one embodiment of an auto-replenishment system  100  constructed in accordance with the disclosure provided herein. The auto-replenishment system  100 , in this exemplary embodiment, includes a medical device  200  in communication with a replenishment center  300  via communications network or link  102 . The medical device  200  may be, for example, an XE-Series Automated Hematology Analyzers designed, manufactured and marketed by Sysmex Corporation®. As used herein, the term medical device is intended to be synonymous with the terms “hematology device”, “medical instrument”, “medical analysis device” and all other reasonable descriptions for a device utilizes reagents and other consumable or replenishable items in a medical or laboratory operation. The medical device  200  may include a communication agent or more specifically a device communication agent  202 . The device communication agent  202  may be any hardware or software module such as a transmitter and/or receiver configured to facilitate communication. For example, the device communication agent  202  may be provided by Axeda Corporation based on technology developed by the Questra Corporation and may enable communications between the medical device  200  and the communications link  102 . The communications link  102  may incorporate the Internet, a virtual private network (VPN), a wide area network (WAN), a public switched telephone network (PSTN) or any other known or foreseeable communications medium. 
         [0029]    The communications link  102  may, in turn, connect the medical device  102  to the replenishment center  300  via a replenishment communication agent  302 . The replenishment communication agent  302  may, similar to the device communication agent  202 , be any hardware or software module configured to facilitate communication. The replenishment center  300  may be any known back office, order processing, material storage and/or order fulfillment center or combination thereof. 
         [0030]      FIG. 2  illustrates a detailed block diagram of the medical device  200  including the components, subsystems, elements and modules relevant and/or utilized in connection with the auto-replenishment system  100 . In this exemplary embodiment, the medical device  200  is shown to include a replenishment subsystem  200   a  and an analysis subsystem  200   b.  It will be understood that the subsystems  200   a  and  200   b  have been identified and/or designated to aid in the explanation and understanding of the auto-replenishment system  100  and is not intended to limit scope and configuration thereof. While these subsystems  200   a  and  200   b  are shown as components or elements of the medical device  200 , they may, in alternative embodiments, be physically separate systems or subsystems in communication with each other. 
         [0031]    The replenishment subsystem  200   a , in this exemplary embodiment, includes the device communication agent  202  in communication with a control module  204  and a database  206 . The control module  204  may include a processor  204   a  communicatively coupled to a memory  204   b.  The memory  204   b  may be any known or contemplated volatile or non-volatile storage medium (e.g., RAM, ROM, a solid state hard drive (SSD), a hard drive (HD), and an optical drive) configured to store program logic and/or computer readable instructions. The processor  204   a  may be any general or specific circuit or controller configured to execute or run the program logic or instructions stored in the memory  204   b.  The processor  204   a  and the memory  204   b  may cooperate to generate and present a graphical user interface (GUI)  204   c  to a user of the medical device  200 . The GUI  204   c  may provide the user access to the replenishment subsystem  200   a , analysis subsystem  200   b  and the replenishment center  300  (see  FIGS. 1 and 3 ) via the communication link  102 . 
         [0032]    The replenishment subsystem  200   a  may, in this exemplary embodiment, include a database  206  configured to store data or information relating to the reagents and other consumable or replenishable items utilized in a medical or laboratory operation. For example, the database  206  may searchably store information or data related to: reagent and/or quality control identifiers; reagent and/or quality control lot identifiers or number; reagent expiration dates, reagent load dates, operational history data; troubleshooting data; and communication logs or data. The database  206  may further be in communication, via the control module  204 , with a tracking module  208  within the analysis subsystem  200   b.    
         [0033]    The tracking module  208  may include both hardware and software necessary to gather, organize and monitor the reagent and quality control information and identifiers stored in the database  206 . For example, the tracking module  108  may include a scanner  208   a  configured to read product information via a barcode associated with each of the reagents or other consumables generally identified by the reference numerals  210   a  to  210   d . Alternatively, the scanner  208   a  may be configured to receive product information contained on a radio frequency identification (RFID) tag associated with each of the reagents or other consumables  210   a  to  210   d . The tracking module  208  may further store cycle and procedure use information received from an analysis module  212 . Alternatively, the analysis module  212  may communicate or copy information directly to the database  206  and/or the control module  204 . 
         [0034]    The analysis module  212  may be fluidly coupled as well as communicatively coupled to the reagents or other consumables  210   a  to  210   d . The analysis module  212  may include the instruments, components, analysis and controls systems necessary to test and analyze patient samples. For example, the medical device  200  may be a hematology device such as an XE-series hematology diagnostic device. In this case, the analysis module  212  may include a semi-conductive laser, cell specific lyse and fluorescent flow cytometry components, platelet preparation and control components. Other device configurations and/or analysis capabilities may require different components. 
         [0035]    The analysis module  212  may further include one or more printers or storage device to saved and report analysis results. Moreover, the analysis module  212  may record locally, or communicate to, for example, the database  206  or the control module  204 , the number of operation or testing cycles performed by the analysis module  212 . As used herein, operation or testing cycles and information includes any functions, sample analyses, cleaning and maintenance activities that deplete or otherwise consume reagents or other replenishable items  210   a  to  210   d.  In another embodiment, the reagents or other replenishable items  210   a  to  210   d  may be monitored, weighed or otherwise measured to directly determine the amounts of each is consumed or utilized during the operation or testing cycles of the medical device  200 . 
         [0036]    The gathered operation information relating to the testing or operational cycles performed by the analysis module  212  may be communicated and/or stored by the database  206  and control module  204 . Moreover, the gathered operation information relating to the testing or operational cycles performed by the analysis module  212  may be combined and correlated with the product information stored in the database  206 . Because the amount of each reagent or other replenishable item  210   a  to  212   d  is known for each test or analysis performed by the analysis module  212 , the combined and correlated data may be analyzed to determine how much of each reagent or other replenishable item  210   a  to  212   d  remains. 
         [0037]    The combined and correlated data can further be analyzed to determine how long the reagents or other replenishable items  210   a  to  212   d  have been loaded onto the medical device  200  and whether or not they are within their expiration periods. The combined and correlated information and/or the operation information may be provided to the device communication agent  202  or transmitter for transmission to the replenishment center  300  and receiver or replenishment communication agent  302  via the communication link  102 . Transmission to the replenishment center  300  may be pushed from the medical device  200  or pulled from the replenishment center  300  at regular intervals or upon occurrence of one or more predefined triggers or flags. For example, the replenishment center  300  may request the combined and correlated data from the medical device  200  on a regular (e.g., daily, hourly) schedule. Inversely, the medical device  200  may provide the combined and correlated data to the replenishment center  300  on a regular (e.g., daily, hourly) schedule during, for example, a predefined working period. The combined and correlated data and/or operation information may be provided in an uncompressed, compressed and/or encrypted format. 
         [0038]    In operation, the user of the medical device  200  may at startup or at the prompting of the GUI  204   c , load one or more reagents or other replenishable items  210   a  to  210   d.  For example, the user may utilize the scanner  208   a  to scan or read a barcode  214   a  associated with the replenishable item  110   a.  The scanned information may be communicated to the database  206  for storage and to the control module  204  for display via the GUI  204   c.  The user may visually verify that the scanned and presented data matches the data on the replenishable item  110   a.  Alternatively, the GUI  204   c  may require the user to record and affirm the data by pressing an ACCEPT button or other graphical or text indication. The scanned information may further be communicated to the analysis module  212  for use in the operation or testing cycles. The scanned information may further include location or position information at which replenishable item  210   a  is coupled to the analysis module  212 . 
         [0039]      FIG. 3  illustrates a detailed block diagram of the replenishment center  300  including the components, subsystems, databases and modules utilized in connection with the auto-replenishment system  100 . The replenishment communication agent  302 , as previously discussed, is in communication with the device communication agent  202  and may be a transmitter and receiver configured to receive and/or request the combined and correlated data from the medical device  200 . The replenishment communication agent  302  may include or be in communication with a communication database  304 . The communication database  304  may store the communication or information request schedule associated with the medical device  200 . The communication database  304  may further include device identifiers such machine serial number, secure internet protocol address, location information or identifiers or any other alias information utilized to uniquely identify the medical device  200 . 
         [0040]    The transmitter and receiver portions of the replenishment communication agent  302  may further be in communication with an auto-replenishment module  306 . The auto-replenishment module  306 , as with the control module  204 , includes the memory and processing capabilities necessary to store, analyze and manipulate the received the combined and correlated data. For example, the auto-replenishment module  306  may include the logic and algorithms to unencrypt and/or decompress the received combined and correlated data. If required, the received the combined and correlated data may be parsed or otherwise manipulated to return it to a usable format. 
         [0041]    The auto-replenishment module  306  may further communicate with an auto-replenishment database  308 . The auto-replacement database  308  may store the details of a service agreement between the user of the medical device  200  and the replenishment center  300 . For example, the auto-replenishment database  308  may include shipping addresses to which the replenishable items  210   a  to  212   d  are delivered; purchase orders to be referenced in any given replenishment order, order history details, maximum credit or charge information, minimum supply thresholds based on previous orders and/or direct query of a customer&#39;s stock system (if allowed). The auto-replenishment module  306  may receive via the receiver portion of the replenishment communication agent  302  the combined and correlated data and/or operation information from the medical device  200 . The auto-replenishment database  308  may, in turn, utilize a record adjustor and/or updater to store the received operation information. The auto-replenishment module  306  and the auto-replenishment database  308  may further include an inventory calculator to determine, based on the known and type of operating cycles performed by the medical device  200 , whether the replenishable item  210   a  has or will be exhausted in the near future. The auto-replenishment database  308  and the auto-replenishment module  306  may further utilize an alert sender to generate and communicate alerts to the medical device  200  if the user attempts to load and/or utilize a replenishable item that has passed an expiration date. 
         [0042]    The auto-replenishment module  306  may query an enterprise resource planning (ERP) module  310  and utilize the inventory calculator to determine, based on order histories, whether a replacement replenishable item  210   a  is available to the user. If a replacement replenishable item  210   a  is available, the records of replenishment center  300  may be updated utilizing the record updater to reflect the change in status. If a replacement replenishable item  210   a  is not available, the ERP system  310  or other suggested order generator may automatically generate a proposed purchase and shipping order to supply a replacement replenishable item  210   a  to the user. For example, if it is determined by the auto-replenishment module  306  that the stock level of the replenishable item  210   a  falls below a predefined threshold stored in the auto-replenishment database  308 , the replenishment center  300  may access the suggested order generator or subroutine to automatically generate a proposed purchase and shipping order to supply a replacement replenishable item  210   a  to the user. In this way, the order may be sent directly to the medical device  200  for approval and/or acknowledgement by the user. 
         [0043]    In another embodiment, a determination by the auto-replenishment module  306  and/or the inventory calculator that the stock level of the replenishable item  210   a  falls below a predefined threshold may trigger an alert in a customer service center (CSC)  312 . In this embodiment, the CSC  312  acting as a suggested order generator generates a proposed purchase and shipping order to supply a replacement replenishable item  210   a  to the user. The CSC  312 , in turn, may utilize the transmitter portion of the replenishment communication agent  302  to communicate the proposed purchase and shipping order to the medical device  200  for confirmation. Utilizing the CSC  312  provides an opportunity to verify and troubleshoot the replenishment process prior to implementing a fully automated system. In addition, the CSC  312  provides a mechanism by which users that do not have the infrastructure to support a fully automated replenishment system may receive many of the benefits of the fully automated replenishment system  100 . 
         [0044]    The proposed purchase and/or shipping orders, regardless of how they are generated at the replenishment center  300 , may be communicated via the transmitter portion of the replenishment communication agent  302  to: the medical device  200  for acceptance, modification or rejection by the user via the GUI  204   c;  a laboratory supervisor for approval; an accounting or inventory department; or to any other desired location or individual responsible for the approval and/or ordering of reagents and other replenishable items. 
         [0045]      FIGS. 4 and 5  illustrate alternate multi-device, multi-location embodiments of the auto-replenishment system  100 .  FIG. 4  illustrates an embodiment of an auto-replenishment system  100  that includes a client having multiple locations and/or multiple medical devices at each location. In this embodiment, a single contract or service agreement may be established between the replenishment center  300  and the medical devices  400 ,  402  at a first location  404  and medical device  406  at a second location  408 . In this embodiment, the service contract may be stored in the replenishment database  308 . The service contract, in turn, may contain and identify each of the medical devices  400 ,  402  and  406  by, for example, a machine serial number, a unique alias or name, an Internet Protocol (IP) address and/or a location identification. In this way, communications to and from the medical devices  400 ,  402  and  406  and the replenishment center  300  may specifically be addressed and delivered to a desired recipient. 
         [0046]      FIG. 5  illustrates an embodiment of an auto-replenishment system  100  that includes a client having multiple locations and/or multiple medical devices at each location. In this embodiment, multiple contracts or service agreements related to a single client or user may be established between the replenishment center  300  and a first location  500  and a second location  502 . The first location  500  may include medical devices  504  and  506  and the second location may include medical devices  508  and  510 . In this embodiment, the service contracts may be stored in the replenishment database  308  and may contain different business rules, thresholds and/or requirements for replacing reagents and/or replenishable items. For example, the first service contract associated with the first location  500  and the medical devices  504  and  506  may define a different replenishment threshold than the second service contract because each location may have different consumption rates, different storage capacity for reagents, replenishable items and other consumables, or each location may require different shipping times based on their relative distance from the replenishment center. 
         [0047]      FIG. 5  further includes, an alternate embodiment, a router or server  512  that may be configured to intercept and direct communications between the medical devices  504  and  506  and the replenishment center  300 . For example, the replenishment center  300  may broadcast a communication to the first location  500  and the router  512  may direct and/or address the communication to one of the intended medical devices  504  and  506 . Alternatively, the router  512  may redirect the communication to an accounting terminal  514  or other supervisory system for approval. In an alternate embodiment, the router or server  512  may act as a collection or aggregation point for the medical devices  504  and  506 . For example, each of the medical devices  504  and  506  may communicate the cycle count and testing information related to the reagent and other consumable or replenishable item stored in the database  206 . The router or server  512  may package, compress or otherwise communicate information related to each of the medical devices  504  and  506  at the first location in a single transmission to the replenishment center  300 . 
         [0048]    The medical devices  400 ,  402 ,  406  and  504  to  510 , as used herein, are intended to contain the same capabilities and functions as the medical device  200  discussed above in connection with  FIGS. 1 and 2 . In other embodiments, each of the medical devices  400 ,  402 ,  406  and  504  to  510  may be different types of medical devices, hematology device or other testing instruments. 
         [0049]      FIG. 6A  illustrates an example of a high level flowchart  600  representative of a normal start up and operational cycle of the medical device  200 . At block  602 , a user may begin a power-up and initialization routine associated with the medical device  200 . The power-up and initialization routine may include a login with a user name and password which may provide access to the functionality of the medical device  200 . Moreover, the user name and password may provide or allow access to the communication functionality provided by the device communication agent  202  and the communication link  102 . In this way, a user may be allowed access to the Internet, other networked equipment and resources. The power-up and initialization routine may include mechanical and software checks intended to place the medical device  200  in operational condition. 
         [0050]    At block  604 , the status of the reagents and other replenishable items  210   a  to  210   d  can be determined. For example, the medical device  200  may automatically weigh or otherwise measure the reagents and other replenishable items  210   a  to  210   d.  Alternatively, the user may visually inspect or evaluate the reagents and other replenishable items  210   a  to  210   d.    
         [0051]    At block  606 , one or more of the reagents and other replenishable items  210   a  to  210   d  has been determined, either automatically or manually, to be low or near exhaustion. A replacement reagent and/or other replenishable item(s)  210   a  to  210   d  may be requested from a local or off-site supply depot or storage and prepared for use when the corresponding reagent or replenishable item is completely exhausted. Once the replacement reagent or replenishable item is prepared and ready for eventual use, the process returns to block  604 . 
         [0052]    At block  608 , the reagents and other replenishable items  210   a  to  210   d  has been determined, either automatically or manually, to be ready for operation. The analysis subsystem  200   b,  and more particularly the analysis module  212 , performs the instructed analysis, testing and/or cleaning cycles. The analysis module  212  may access reagent and/or replenishable item information in database  206  as shown by way of example in Table 1. The first two columns of Table 1 provide the complete name and an abbreviation for each of the reagents and/or replenishable items, respectively. The third column provides an approximate number of cycles and/or tests which may be expected from a given known reagent and/or replenishable item. The fourth column provides the size and/or volume of each container of reagent and/or replenishable item. 
         [0000]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 1 
               
             
             
               
                   
               
               
                 Approximate number of cycles per particular reagent, which may 
               
               
                 be run by the medical device 200. 
               
             
          
           
               
                 Replenishable 
                   
                 # of cycles per 
                 Capacity per 
               
               
                 Item 
                 Abbreviation 
                 container 
                 container 
               
               
                   
               
             
          
           
               
                 Cellpack 
                 EPK 
                 Approx. 660 
                 20.0 
                 L 
               
               
                 Cellsheath 
                 ESE 
                 Approx. 7300 
                 20.0 
                 L 
               
               
                 Stromatolyser-FB 
                 FBA 
                 Approx. 2750 
                 5.0 
                 L 
               
               
                 Stromatolyser- 
                 FFD 
                 Approx. 2750 
                 5.0 
                 L 
               
               
                 4DL 
                   
                   
                   
                   
               
               
                 Stromatolyser- 
                 FFS 
                 Approx. 200 
                 42  
                 mL 
               
               
                 4DS 
                   
                   
                   
                   
               
               
                 Stromatolyser- 
                 SNR 
                 Approx. 2000 
                 3.6 
                 L 
               
               
                 NR(L) 
                   
                   
                   
                   
               
               
                 Stromatolyser- 
                 SNR 
                 Approx. 2000 
                 43 
                 mL 
               
               
                 NR(S) 
                   
                   
                   
                   
               
               
                 Sulfolyser 
                 SLS 
                 Approx. 10000 
                 5.0 
                 L 
               
               
                 Stromatolyser-IM 
                 SIM 
                 Approx. 3200 
                 10.0 
                 L 
               
               
                 Ret. Search (II)- 
                 RED 
                 Approx. 550 
                 1.0 
                 L 
               
               
                 (Diluent) 
                   
                   
                   
                   
               
               
                 Ret. Search (II) - 
                 RED 
                 Approx. 550 
                 12 
                 mL 
               
               
                 (Die solution) 
               
               
                   
               
             
          
         
       
     
         [0053]    Based, at least in part, on the information represented in Table 1, the analysis module  212  may cooperate with the database  206  and the tracking module  208  to generate a cycle count analysis. Alternatively, the cycle count analysis may be performed at the auto-replenishment module  306  utilizing the inventory calculator. Table 2 illustrates an exemplary cycle count analysis that details cycle test versus reportable test count generated and provided by the analysis module  212 . The first column of Table 2 indicates the tests or procedures that may be performed by the medical device  200 . The second through the fifth columns break down the cycle count associated with a medical device  200  into different count categories. For example, the second list the approximate number of cycles that can be conducted before a given reagent or other consumable item is depleted. The third column lists the approximate number of rerun or retests that may be conducted by the medical device  200  during testing of various patient samples. The fourth column indicates the number of quality control, cleaning and or maintenance cycles that may be conducted by the medical device  200  during testing of various patient samples. The sixth column provides a total of the preceding three columns while the seventh column lists the total number of cycles that may be reported for the purposes of replenishment. In other words, to analyze six hundred patient samples, it may be necessary to conduct six hundred and sixty cycles. 
         [0000]    
       
         
               
             
               
               
               
             
               
               
               
               
               
               
             
               
               
               
               
               
               
             
           
               
                 TABLE 2 
               
             
             
               
                   
               
               
                 Cycle count versus reportable test count 
               
             
          
           
               
                   
                 Cycle Count 
                   
               
             
          
           
               
                 Test 
                 Order 
                 Rerun 
                 QC 
                 Total 
                 Reportable 
               
               
                   
               
             
          
           
               
                 1 
                 600 
                 50 
                 10 
                 660 
                 600 
               
               
                 2 
                 500 
                 45 
                 10 
                 555 
                 500 
               
               
                 3 
                 100 
                 5 
                 5 
                 110 
                 100 
               
               
                 4 
                 150 
                 10 
                 5 
                 165 
                 150 
               
               
                 Total 
                 1350  
                 110 
                 30 
                 1490  
                 1350 
               
               
                   
               
             
          
         
       
     
         [0054]    At block  610 , the analysis module  212  and tracking module  208  may cooperate with the control module  204  and database  206  to determine reagent and replenishable item utilization. For example, because the amount of each reagent or other replenishment item used for each given test is known and fixed, because the number of test, maintenance and/or cleaning cycles is known and record, the quantity of reagent and replenishable item utilized may be determined and compared to capacity per container (see Table 1). Once programmed tests and analysis have been completed by the medical device  200 , and the reagent and/or replenishable item status is determined, stored and reported, the process returns to block  604 . 
         [0055]    If one or more of the reagents and other replenishable items  210   a  to  210   d  has been determined, either automatically or manually, at block  604  to be exhausted, the process moves to block  612 . If the exhausted replenishable item its determined automatically, the control module  204  and GUI  204   c  may display an alert. At this point the user of the medical device  200  may clear or otherwise acknowledge the alert. The alert may further signify a shutdown or pause in any ongoing analysis or test conducted by the analysis module  212 . In another embodiment, the alert may trigger or otherwise initiate a communication or update to the database  206  and/or the replenishment center  300  via the communication link  102 . 
         [0056]    At block  614 , the user may retrieve the previously prepared replacement reagent and/or replacement item discussed in connection with block  606 . However, should this be the first indication or a depleted reagent and/or replenishable item, the user may be required to retrieve a replacement from a stock room or other storage location. The replacement reagent may be scanned for use via the scanner  208   a.    
         [0057]    At block  616 , the information retrieved via the scanner  208   a  may be displayed via the GUI  204   c  for verification, communicated to the database  206  for storage and/or communicated to the replenishment center  300 . 
         [0058]    At block  618 , the cycle counter may be reset to zero (0) with respect to the replaced reagent or replenishable item. The resetting process may be accomplished automatically via a user input received and processed via, for example, the GUI  204   c.  Alternatively, the resetting process may be triggered or initiated by the action of scanning the replacement or clearing the alert. 
         [0059]    At block  620 , an automatic or auto-cleaning function may be initiated. The auto-clean function may include preparing or priming the medical device with replacement reagent or other replenishable item loaded thereon. Alternatively, the auto-clean function may include the analysis module  212  and include preparing the included subsystems for operation. Once resupply operation has been completed and the medical device  200  is once again fully operational, and the reagent and/or replenishable item status is determine, stored and reported, the process returns to block  604 . 
         [0060]      FIG. 6B  illustrates an exemplary communication and update process between the medical device  200  and the replenishment center  300 . 
         [0061]    At block  624 , the user may interact with the GUI  204   c  to identify and select one or more tests and/or analyses to be performed on a patient sample. In response to a user command, the medical device  200  executes and performs one or more analysis processes on the patient sample. 
         [0062]    At block  626 , the medical device  200  may index and update a test or maintenance counter detailing the type of tests performed in response to the user&#39;s selection(s). 
         [0063]    At block  628 , the analysis module  212  and/or the tracking module  208  of the medical device  200  may update and store the updated test counter information in the database  206 . The updated test counter information may include a time stamp to allow creation of a time based history file or record within the database  206 . The history file may in turn be utilized to predict usage patterns for the medical device  200 . Alternatively, the updated test counter information may be stored at a specific memory location within the database  206  such that it overwrites any previously stored test counter information. The updated test counter information may, in another embodiment, be combined or augmented with any or all of the correlated data stored within the database  206 . 
         [0064]    At block  630 , the updated test counter information may be communicated from the database  206  to the transmitter portion of the device communication agent  202  and the communication link  102 . 
         [0065]    At block  632 , the updated test counter information may be received by the receiver portion of the auto-replenishment communication agent  302 . The received test counter or operation information may, in turn, be utilized by the inventory calculator portion of the auto-replenishment module  306  and/or the record updater portion of auto-replenishment database  308  of to the replenishment center  300 . 
         [0066]      FIGS. 6C and 6D  illustrate exemplary interactions between the medical device  200  and the auto-replenishment center  300  during a manual and/or automatic replenishment operation. At block  634 , the replenishment center  300  may manually or automatically, according to a pre-determined schedule, begin utilizing the inventory calculator to perform a replenishment analysis for one or more medical devices. For example, a timed schedule may be established that results in the replenishment analysis being conducted every twenty-four (24) hours. Alternatively, the replenishment analysis may be initiated manually by the replenishment center. 
         [0067]    Alternatively, at block  640 , the user of the medical device  200  may manually initiate the replenishment process by accessing, either via the medical device itself or an Internet website, an e-supply menu screen  750  (see  FIG. 7A ). 
         [0068]    At block  636 , the auto-replenishment module  306  may access and evaluate the updated test counter information provided at block  632  of  FIG. 6B . For example, the auto-replenishment module  306  may utilize the inventor calculator to calculate the reagent  210   a  remaining based on the difference between the initial amount of reagent (see Table 1) and the number and type of tests performed (see Table 2). The remaining amount of reagent may be compared to a threshold to determine if resupply is in order. In one embodiment, the threshold may be fifty percent (50%) of, for example, the total number of replenishable item boxes in inventory and/or the initial volume of a reagent or replenishable item. In another embodiment, the threshold may be dynamically calculated based on the history file and delivery time associated with replacement order. If the remaining reagent exceeds the threshold, the process may terminate and return to block  634  to await the next scheduled or manual activation. 
         [0069]    If the inventory calculator that performs the replenishment analysis determines that the remaining amount of a replenishable item is less than the threshold, then at block  638 , the auto-replenishment module  306  may determine that the remaining reagent is below the threshold thereby triggering a replenishment alert to be generated by an alert sender portion of the replenishment communication agent  302 . The replenishment alert generated by the alert sender may be communicated via the transmitter portion of the replenishment communication agent  302  to the GUI  204   c  of the medical device  200 . Alternatively, the replenishment alert generated by an alert sender portion of the replenishment communication agent  302  may be an email alert containing a link to the e-supply menu screen  750  shown in  FIG. 7A . 
         [0070]    At block  642 , the e-supply menu screen  750  and/or the replenishment alert provides access, via the GUI  204   c , to a replenishment order screen shown in  FIG. 7B . In this example, it will be assumed for clarity that the replenishment order screen shown in  FIG. 7B  is accessed by the replenishment alert generated by the alert sender discussed above. The replenishment alert may identify the reagent or other replenishable item determined to need replacement (in this example the reagent  210   a ), may suggest a replacement amount and/or may identify the stock levels as determined by the auto-replenishment module  306 . The replenishment alert may provide the ACCEPT, REJECT and MODIFY functionality discussed in connection with  FIGS. 7A to 7E . 
         [0071]    At block  644 , the user may interact with the GUI  204   c  to accept the proposed purchase order via the SUBMIT button  710 . 
         [0072]    At block  646 , prior to final acceptance and submission of the proposed purchase order delivered via the replenishment alert, the user may modify the proposed or recommended quantity. The proposed or recommended quantity may be determined by one or more business rules stored by the auto-replenishment database  308 . For example, the auto-replenishment database  308  may store previous orders and based on usage or consumption patterns attempt to predict and recommend the proposed resupply amount. Alternatively, the auto-replenishment database  308  may store a fixed resupply amount based on stock and/or usage level desired by the user. 
         [0073]    At block  648 , if the user has decided to modify the proposed or recommended quantity, the user has a further opportunity to provide comments, instructions and/or other information during the acceptance/submission process. 
         [0074]    At block  650 , the information gathered via the proposed and/or modified purchase order may be communicated via the transmitter portion of the device communication agent  202  to the replenishment center  300 . 
         [0075]    At block  652 , the information received by the receiver portion of the replenishment communication agent  302  at the replenishment center  300  may be utilized by the auto-replenishment module  306  to process and complete the proposed replenishment order. 
         [0076]    At block  654 , an acknowledgement message or receipt may be transmitted or communicated from the replenishment center  300  to the medical device  200 . The acknowledgement message or receipt may be displayed by the GUI  204   c  as an order confirmation screen  760  (see FIG.  7 E). Alternatively, the acknowledgement message may be delivered to one or more email clients designated by the user. 
         [0077]    If the user at block  644  does not submit or accept the proposed replenishment order, then at block  656  the user has the opportunity to reject the proposed purchase order. 
         [0078]    At block  658 , if the user has decided to reject the proposed or recommended quantity, the user has an opportunity to provide comments, instructions and/or other information. The provided comments may serve to modify future proposed purchase orders, modify delivery instructions and/or provide any addition information deemed important by the user. 
         [0079]    At block  660 , the order rejection information may be communicated via the transmitter portion of the device communication agent  202  to the replenishment center  300 . 
         [0080]    At block  662 , the rejection information received at the replenishment center  300  may be utilized by the auto-replenishment module  306  to update the information stored in the auto-replenishment database  308 . 
         [0081]    At block  664 , a secondary replenishment alert may be established or generated by the alert sender to act as a reminder or backup. The secondary replenishment alert may be emailed or otherwise transmitted to the medical device  200  after, for example, a proscribed period of time (e.g., a day, a week, etc.), a predefined increase in the test counter, the remaining reagent volume falls below a second threshold that is less than the first threshold. 
         [0082]    At block  666 , the secondary replenishment alert may be delivered to the receiver portion of the device communication agent  202  of the medical device  200 . The secondary replenishment alert may be received via an email client or displayed via the GUI  204   c.    
         [0083]    If at block  656  the user does not reject the proposed replenishment purchase order, then at block  668 , the stock quantities stored at the replenishment center  300  may be evaluated and updated. 
         [0084]    At block  670 , a request for stock information made be generated and communicated to the replenishment center  300 . 
         [0085]    At block  672 , the received stock information request may cause the auto-replenishment module  306 , the auto-replenishment database  308  and/or the ERP  310  to package and communicate the requested information. 
         [0086]    At block  674 , the requested information is delivered to the medical device and displayed via the GUI  204   c.  In particular, the received information may be formatted and displayed as shown in  FIG. 7C . 
         [0087]    At block  676 , the user may interact with the GUI  204   c  to adjust or otherwise change the stock quantities stored at the replenishment center  300 . 
         [0088]    At block  678 , the updated quantity information may be communicated via the transmitter portion of the device communication agent  202  to receiver portion of the replenishment communication agent  302  of the replenishment center  300 . 
         [0089]    At block  680 , the stock information stored at auto-replenishment module  306 , the auto-replenishment database  308  and/or the ERP  310  may be updated utilizing the record adjuster to reflected to information provided by the user. 
         [0090]    If at block  668  the user does not modify or adjust the stock quantities stored at the replenishment center  300 , then at block  682 , a report detailing current and past replenishment orders may be requested and generated. 
         [0091]    At block  684 , a request for report information made be generated and communicated to the replenishment center  300 . 
         [0092]    At block  686 , the received report information request may cause the auto-replenishment module  306 , the auto-replenishment database  308  and/or the ERP  310  to package and communicate the requested information. 
         [0093]    At block  688 , the requested information is delivered to the medical device and displayed via the GUI  204   c.  In particular, the received information may be formatted and displayed as shown in  FIG. 7D . 
         [0094]    If, at block  682 , a report request is not generated, the process may continue and/or return to block  642  and await further commands. 
         [0095]      FIGS. 7A to 7E  illustrate auto-replenishment interface screens that may be presented via the GUI  204   c.    FIG. 7A  illustrates an e-supply menu screen  750  that may be accessed by the user. For example, the user may interact with the GUI  204   c  and an e-supply link  752  to access the functionality provided by the replenishment center  300 . Alternatively, the user may selected an active link or hyperlink embedded within the secondary replenishment alert to access the e-supply menu screen  750 . For example, by selecting the hyperlink, the user may be directed to a secure webpage hosted by the replenishment center  300 . 
         [0096]      FIG. 7B  illustrates a review screen  700  which may be generated at and provided by the replenishment center  300  in response to the combined and correlated data received from the medical device  300 . In an alternate embodiment, the review screen may be generated at the medical device  200  and communicated to the replenishment center  300 . The review screen  700  may include a part number  702  or stock keeping unit (SKU) and a name  704  identifying each of the reagents, consumables and/or replacement items. 
         [0097]    The review screen  700  may further include a recommended quantity  706  that may be supplied and specified by the business rules stored and implemented by the auto-replenishment database  308  and the auto-replenishment module  306 , respectively. The recommended quantity business rule could, in another embodiment, be stored and implemented by a local accounting department, ERP or stored in the database  206 . THE recommended quantity could be determined based on past order and/or usage patterns, known or calculated consumption rates and/or fixed amounts requested by the user. 
         [0098]    The review screw  700  may further include an actual quantity  708  which may be adjusted or modified manually. A “SUBMIT” button  710  allows the user to confirm the order can initiate communication of the same to the replenishment center  300  for fulfillment. Alternatively, a “REJECT” button 712 allows the user to reject the recommended or provided order. 
         [0099]      FIG. 7C  illustrates a stock screen  714  which may be presented via the GUI  204   c.  As previously described, the stock screen  714  may include the part number  702  and the name  704  of a given reagent or replenishable item available or accessible to the medical device  200 . The stock screen  714  may further provide a manufacturing lot number  716  and/or an expiration date  718  for each listed item. The stock screen  714  may further provide a stock amount  720  that reflects the quantity of an item available to the medical device  200  as reflected by data stored at the replenishment center  300 . Thus for an item reflecting a stock amount  720  of one (1), the records kept at the replenishment center  300  relating to the medical device  200  indicate that a replacement item is available. Available items may be items or parts stored locally (e.g., within the laboratory), stored in a common facility that serves multiple laboratories or an item that may be delivered quickly, and without expedited costs, from a supply depot or warehouse. If the records of the replenishment center  300  are inaccurate for any reason, the user of the medical device may update/correct the information and submit the same to the replacement center via the SUBMIT button  710 . 
         [0100]      FIG. 7D  illustrates a tracking screen  722  that may be provided via the GUI  204   c.  The tracking screen  722  may include an order identifier  724  as well as a purchase order number  726  associated with a given order. The tracking screen  722  may include a shipping status  728  (e.g., in process, shipped, delivered, alert) as well as tracking information  730  provided by, for example, a shipper or carrier. The tracking screen  722  may further include the name and/or time stamp  732  necessary to identify anyone that changes, accepts or rejects a recommended or pending order. In this way, the auto-replenishment system  100  provides a mechanism to track users of the medical device  200  as well as utilization of the reagents and other replenishable items. 
         [0101]      FIG. 7E  illustrates an order confirmation screen  760  or receipt which may be provided to the user via the GUI  204   c . For example, upon submission of a modified, unmodified or rejected order, the replenishment center  300  may communicate a confirmation message  762  to acknowledge receipt of the instructions provided by the user. 
         [0102]    The information provided via the screens  700 ,  714 ,  722 ,  750  and  760  may, in other embodiments, be directed to an accounting or purchasing department, a supervisors work station or to a different medical device identified by the replenishment center  300 . Alternatively, the information may be provided as a receipt or confirmation where orders are fulfilled automatically, based on business rules such as, minimum order quantity, maximum purchase amount or limit, one or more timing constraints, etc. 
         [0103]    It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the present invention and without diminishing its intended advantages. It is therefore intended that such changes and modifications be covered by the appended claims.