Abstract:
The present invention relates to a method and apparatus for managing patient data. In one aspect, the invention relates to a system for managing patient data having many instruments. The instruments have a sampling member for sampling a body fluid from a patient and are in direct communication with at least one other instrument.

Description:
FIELD OF THE INVENTION 
     The invention relates to a method and system for managing patient data. Specifically, the invention relates to an analytical instrument in direct communication with at least one other analytical instrument over a network for accessing patient data acquired by the other analytical instrument. 
     BACKGROUND OF THE INVENTION 
     Medical facilities such as hospitals and doctor&#39;s offices employ numerous medical devices to obtain and/or analyze samples from patients. These analytical instruments are often placed at different locations throughout the medical facility. 
     Typically, such instruments are connected to or communicate with a stand-alone computer to perform the data management functions relating to the processing of patient data. However, several problems exist with this arrangement. For example, the user must physically walk to the computer to see and/or manipulate the data from a particular device. In another example, the computer typically has a different user interface than the user interface of the instrument. Furthermore, in facilities using different instruments for different procedures, each instrument may have its own interface. These different user interfaces require the user to learn how to navigate through each user interface to perform the necessary tasks, and to quickly distinguish the differences between them. Moreover, if an analytical instrument is used outside of the facility in which it normally operates, the user would be unable to perform the data management functions without the stand-alone computer, or without having to return the instrument to the facility prior to performing any of these functions. This results in a cumbersome requirement to maintain the data management capabilities when the user travels with the instrument. 
     The medical facility may also employ a server computer for the storage of information associated with, for instance, the analytical data. The instruments (or other computers) traditionally communicate with the server to access the information. A user located at the server, however, cannot typically analyze a sample. Also, if many instruments request information from the server at approximately the same time, communications may be delayed. Moreover, if the server experiences a failure and has to be repaired, the retrieval of the data is delayed until the problem is fixed or until another server replaces the faulty server. Such server-centric arrangements can result in a chain reaction of inefficiencies such as data unavailability and inefficient medical treatment. 
     SUMMARY OF THE INVENTION 
     The present invention relates to a method, system, and apparatus for managing patient data. In one aspect, the invention relates to a system for managing patient data having many instruments. The instruments have a sampling member for sampling a body fluid from a patient and directly communicate with each other. 
     The direct communication can include a first instrument controlling a second instrument. The control can include, for instance, the first instrument calibrating the second instrument, the first instrument processing a sample on the second instrument, the first instrument turning the second instrument off, and/or the first instrument turning the second instrument on. The direct communication can include one instrument being in direct communication with at least two other instruments, and the communication can be unidirectional or bidirectional. 
     In one embodiment, the direct communication includes one instrument accessing patient data acquired by another instrument. The accessing of patient data can include viewing status of another instrument, viewing one or more operations on another instrument, and searching patient results on at least one other instrument. In one embodiment, one instrument can operate as an agent for one or more of the other instruments, and thereby can transmit to and receive data from another instrument subsequent to the other instrument acquiring and/or accessing patient data. 
     In some embodiments, the system also includes a single user interface for managing the analysis of the body fluid sample and patient data. The data acquired or stored in each instrument can be displayed in a common format. 
     In another aspect, the invention relates to an instrument having an analytical module, a data management module, and a communications module. The analytical module analyzes a body fluid sample. The data management module within the instrument enables management of data associated with the body fluid sample. The communications module facilitates instrument-to-instrument communications. In some embodiments, the instrument also includes a user interface for receiving user instructions relating to the analytical module, the data management module, and the communications module. In one embodiment, the management of data includes generating a report, (which, in some cases may be generated automatically) managing security information, performing competency testing, determining a pattern associated with the instrument, performing inventory management, quality control, and/or determining the workload of the instrument. 
     The data can include patient data, which may be combined with the analytical data associated with the analysis of the body fluid sample. The report can include a quality control report, a regulation report, and a workload report. Moreover, the report can be automatically generated. In one embodiment, the performance of competency testing can be determining a pattern of occurrences to facilitate better training. 
     In yet another aspect, the invention relates to a method for accessing patient data. The method includes connecting the instruments to a network. Each instrument includes a sampling member for sampling a body fluid from a patient. The method also includes the steps of sampling, by the sampling member of a first instrument, a body fluid from a patient and accessing, and analyzing the sample. A second instrument then accesses the results of the analysis directly from the first instrument. In some embodiments, an instrument initiates a configuration process on one or more of the plurality of instruments according to predetermined acceptable ranges of the results of the analysis. 
     In another aspect, the invention relates to a system for managing patient information including a collection of instruments, each instrument including a sampling member for sampling a body fluid. The system also includes a collection of communications modules, each communication module being associated with an instrument, and directly exchanging patient information with other instruments without the patient information being permanently stored or processed on an apparatus other than one of the instruments. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a block diagram of a system having a first, second, and third instrument communicating over a network according to an illustrative embodiment of the invention. 
         FIG. 2  is a block diagram of a system having a server communicating with a first and second instrument over a network according to an illustrative embodiment of the invention. 
         FIG. 3  is a block diagram of an instrument having a user interface and a data management module according to an illustrative embodiment of the invention. 
         FIG. 4  is a flow diagram of the steps performed for configuring the instruments of  FIG. 1  according to an illustrative embodiment of the invention. 
         FIG. 5  is a flow diagram of the steps performed for using the instruments of  FIG. 1  according to an illustrative embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  is a block diagram of a system  100  having a first instrument  104 , a second instrument  104 ′, and a third instrument  104 ″ (generally instrument  104 ) communicating over a network  116  according to an illustrative embodiment of the invention. Examples of instruments  104  include but are not limited to a GEM Intelligent Quality Management (iQM) 3000 analyzer, a GEM Intelligent Quality Management (iQM) 4000 analyzer (both from Instrumentation Laboratory, Lexington, Mass.), and a VITROS DT60 II Chemistry System (Johnson &amp; Johnson, Piscataway, N.J.). Other instruments may be, for example, a hand-held instrument such as a handheld glucose sensor. The instruments  104  can be located in, for instance, a hospital, a doctor&#39;s office, a medical facility, a patient&#39;s home, an elderly care facility, an ambulance, public transportation vehicles, large public venues, or any other location in which medical analysis and/or patient data sampling occurs on either a routine or emergency basis. For example, one instrument of the system may be located in a hospital, and another one of the instruments may be located in a doctor&#39;s office. Alternatively, all of the instruments may be located in a hospital, but at remote locations throughout the hospital. In some cases, the instruments  104  travel throughout the facility, thereby introducing the possibility that any instrument  104  could be at any location at any time. Each instrument  104 ,  104 ′,  104 ″ includes a respective sampling member  120 ,  120 ′,  120 ″ (generally sampling member  120 ). An example of a sampling member  120  is a probe for contacting the sample, an inlet port for receiving a sample, a receptacle for receiving a sample cartridge, or a sample cuvette, for example. Each sampling member  120 ,  120 ′,  120 ″ can sample a body fluid from a patient. Examples of a body fluid include blood, serum, plasma, urine, semen, saliva, tracheo-bronchial washing, cerebrospinal fluid, and the like. The sampling member  120 ,  120 ′,  120 ″ can analyze a body fluid to determine qualitatively or quantitatively the amount or presence of one or more target analytes in the body fluid. Although described below with respect to the first instrument (“instrument  104 ”), the description applies to any or all of the instruments  104 ,  104 ′,  104 ″. Similarly, although the description below is with respect to the first sampling member  120  (“sampling member  120 ”), the description applies to any or all of the sampling members  120 ,  120 ′,  120 ″. 
     As used herein, accessing patient data means one instrument  104  directly accessing data on another instrument  104 ′, i.e., a central processing unit (CPU) or server positioned between the first and second instruments  104 ,  104 ′, respectively, is not necessary for the first and second instruments to access data from each other. Acquiring patient data means when one instrument  104  analyzes a target component in a patient body fluid sample. In one embodiment, the acquiring of patient data includes using the sampling member  120  to obtain a patient sample. Patient data is patient personal data and patient clinical data. Personal data can include, for example, name, gender, residence, age, height, weight, sex, allergies, and/or health history. Clinical data can include a qualitative or quantitative determination of a target analyte in a patient body fluid sample. 
     As used herein, direct communication between two instruments  104 ,  104 ′ means one instrument  104  communicating with another instrument  104  without the aid of a central CPU or computer that is incapable of sampling a body fluid from a patient (i.e., that is not an instrument  104 ) and that provides additional data processing functionality with respect to the analysis, storage, display, or manipulation of the data other than devices such as routers, repeaters, or switches that manage, direct, and/or amplify messages over the network  116 . Examples of direct communication among the instruments  104  includes, but is not limited to peer-to-peer communications, and communications over a mesh-type network whereby one or more of the instruments  104  can also assist with the transmission of a message from a first instrument  104  to a second instrument  104 ′. 
     To facilitate the direct communications among the instruments  104 , each instrument  104  contains or is connected to (either permanently or on an ad hoc basis) a communication module  124 . The communication module  124  maintains identification and routing information related to the plurality of instruments within the system, and packages instructions, data and other information as messages in such a manner that when broadcast, the message contains the routing information necessary to reach its intended destination (i.e., a second instrument  104 ′) without the aid of a central server. The communications module  124  also receives messages, and decodes, decrypts, and/or compiles the message into instructions for the second instrument  104 ′. In some embodiments, the communications module  124  also provides confirmation messages back to the first instrument  104  to confirm that a message has been received, understood, and/or acted upon. 
     With continued reference to  FIG. 1 , the direct communication between the first instrument  104  and second instrument  104 ′ is shown with a first communications channel  144 . Similarly, the direct communication between the first instrument  104  and third instrument  104 ″ is shown with a second communications channel  148 . Moreover, the direct communication between the second instrument  104 ′ and third instrument  104 ″ is shown with a third communications channel  152 . 
     The network  116  can be, for instance, an intranet. Example embodiments of the communication channels  144 ,  148 ,  152  include standard telephone lines, LAN or WAN links (e.g., T1, T3, 56 kb, X.25), broadband connections (ISDN, Frame Relay, ATM), and wireless connections (802.11). 
     With continued reference to  FIG. 1 , the direct communication between, for instance, the first instrument  104  and the second instrument  104 ′ enables the first instrument  104  to access patient data acquired by the second instrument  104 ′. Likewise, the direct communication between the other instruments  104  enables one instrument (e.g., the second instrument  104 ′) to access patient data acquired by another instrument (e.g., the third instrument  104 ″) in direct communication with the instrument  104  (e.g., the second instrument  104 ′). In one embodiment, the direct communication between two or more instruments  104  is bidirectional. For example, when the first and second instruments  104 ,  104 ′ are in direct communication, the first instrument  104  can communicate with and obtain information from the second instrument  104 ′ and the second instrument  104 ′ can likewise communicate with and obtain information from the first instrument  104 . In another embodiment, the direct communication is unidirectional such that the first instrument  104  can communicate with and obtain information from the second instrument  104 ′ but the second instrument  104 ′ cannot initiate communications with and obtain information from the first instrument  104 . Thus, independent of which instrument&#39;s sampling member  120  samples a patient&#39;s body fluid, any instrument  104  communicating over the network  116  can access data associated with the body fluid directly from the instrument  104  that sampled the body fluid. 
       FIG. 2  is a block diagram of a system operating in such a manner that an agent-instrument  204  communicates with the first instrument  104  and the second instrument  104 ′ over a network according to another illustrative embodiment of the invention. In one embodiment, the agent-instrument  204  acts as an agent for the first instrument  104  and the second instrument  104 ′, i.e., the agent-instrument  204  can perform the functions that can be performed on the first and second instruments  104  and  104 ′. For example, the agent-instrument  204  stores the clinical data associated with a sample obtained by a sampling member of one or more of the instruments  104 . Thus, in one embodiment, the agent-instrument  204  enables an instrument  104  to access patient data acquired by another instrument  104  by storing the patient data in a database and performing other centralized data processing functions. Thus, when a sampling member  120  samples a body fluid from a patient, the instrument  104  stores the patient data obtained from the sample. Additionally, the instrument  104  that acquired the sample also transmits the patient data to the agent-instrument  204 . The agent-instrument  204  enables the other instruments  104  to access all patient data from a single instrument (rather than having to access patient data at all instruments  104  that sampled a sample from the patient). Alternatively, instruments  104  can communicate with the instrument  104  that sampled the patient&#39;s body fluid to obtain data associated with the body fluid. 
     In one embodiment, the agent-instrument  204  also transmits the patient data to a hospital information system  208 . For example, the agent-instrument  204  transmits the patient data to the hospital information system  208  through a laboratory information system (LIS) interface. The hospital information system  208  can be, for example, another computer in the same (or different) hospital as the medical facility where the instruments  104  are located. The hospital information system  208  maintains a patient database for the hospital&#39;s patients. The agent-instrument  204  may also retrieve information from the hospital information system  208 . 
     In one embodiment, one instrument  104  (e.g., the first instrument  104 ) directly communicates with another instrument  104  (e.g., the second instrument  104 ′) to control the instrument (e.g., the second instrument  104 ′). If, for instance, the first instrument  104  is controlling the second instrument  104 ′, the first instrument  104  calibrates the second instrument  104 ′, initiates the processing of a patient sample on the second instrument  104 ′, turns the second instrument  104 ′ on, and/or turns the second instrument  104 ′ off. The first instrument  104  can also control the second instrument  104 ′ by initiating a specific measurement of an analyte in the patient sample. 
     Additionally, in one embodiment, the first instrument  104  controls a heterogeneous second instrument  104 ′, i.e., the second instrument  104 ′ is a different model or type compared with the first instrument  104 . For example, in one embodiment the first instrument  104  is a GEM Intelligent Quality Management (iQM) 4000 analyzer and the second instrument  104 ′ is a GEM Intelligent Quality Management (iQM) 3000 analyzer (both from Instrumentation Laboratory, Lexington, Mass.). Moreover, in one embodiment the first instrument  104  controls a second instrument  104 ′ that is manufactured by a different company altogether. For example, the first instrument  104  is a GEM iQM 4000 analyzer and the second instrument  104 ′ is a VITROS DT60 II Chemistry System (Johnson &amp; Johnson, Piscataway, N.J.). 
       FIG. 3  is a block diagram of an instrument  104  having a user interface  316  and a data management module  320  according to an illustrative embodiment of the invention. In the illustrated embodiment, the sampling member  120  of the instrument  104  has an analytical module  304  for analyzing patient data. In particular, the analytical module  304  is a software module providing a programmed series of steps that analyzes a target analyte in a body fluid sample from a patient. For example, the target analyte is blood platelet concentration, white blood cell concentration, red blood cell concentration, blood urea nitrogen (BUN), blood gases, electrolytes, metabolites, and/or hematocrit. 
     The instrument  104  also includes a user interface  316  and a data management module  320 . The data management module  320  enables management of the patient data. The data management module  320  can manage patient data that is stored on the instrument  104  that the data management module  320  is executing on and/or can manage patient data stored on another instrument  104 . For example, the data management module  320  of the first instrument  104  can perform management functions on data associated with a particular patient that the first instrument  104  accesses from the second instrument  104 ′. 
     The user interface  316  enables a user of the instrument  104  to perform functions associated with the analytical module  304  and the data management module  320 . Specifically, the user interface  316  performs functions and displays patient data in a common format on the instruments  104 . Thus, the user interface  316  enables the user of the instrument  104  to experience a single “look and feel” when sampling a body fluid sample, analyzing the sample, and/or managing patient data regardless of the instrument. As an example, a common menu structure can be employed such that the messaging functions all appear under one menu option that is consistent across all instruments  104 , and operational functions such as processing a patient sample can be described using common terminology, with like screen coloring, command controls, and help text. The analytical module  304 , the user interface  316 , and the data management module  320  are software modules that can be written in any computer programming language, such as Java or C++. In some embodiments where the instruments  104  are manufactured by different vendors, a browser-like interface may be included as the user interface  316 , thus enabling the use of standard data rendering, data transmission, and data presentation technologies such as HTML, HTTP/HTTPS, XML, SOAP, Web Services, and the like. Examples of browser interfaces include, but are not limited to applications such as Internet Explorer, by MICROSOFT CORPORATION of Redmond, Wa., NETSCAPE NAVIGATOR, by AOL/TIME WARNER of Sunnyvale, Calif., and MOZILLA FIREFOX by the MOZILLA FOUNDATION of Mountain View, Calif. 
     The user interface  316  enables a user to, for example, view a snapshot of the instrument screen display, review patient data or quality control results, review the instrument&#39;s status, enable or disable analytes, enable or disable operator access, lock the instrument  104 , calibrate the instrument  104 , configure the instrument  104  according to predetermined acceptable ranges of the results of the analysis of the patient data, and/or post a message on the instrument  104 . Moreover, the user of an instrument  104  can use the user interface  316  to perform these functions on any other instrument (e.g., the second instrument  104 ′). Thus, a user can use the user interface  316  to view patient data acquired by the instrument  104  including the user interface  316  or another instrument  104 , view the status of this or another instrument  104 , view operations performed on this or another instrument  104  (e.g., analyze a patient sample, prepare a pie chart for all patient data for a particular patient, etc.), and/or search patient results on this or another instrument  104 . As described above, the instruments  104  may be heterogeneous types, e.g., instruments manufactured by different companies altogether. 
     Examples of data management functions that the data management module  320  can perform include generating a report, managing security information, performing competency testing, and determining the workload of the instrument  104 . For instance, the data management module  320  can automatically generate a table of the previous ten data points obtained for a target analyte of a patient&#39;s body sample. The data management module  320  can also generate a report (e.g., a table) on demand or periodically as based on a predetermined schedule. The user of the instrument  104  can also use the data management module  320  to search for patterns, such as a pattern in a patient&#39;s clinical data. Moreover, the user can additionally use the data management module  320  to discern data patterns associated with one or more instruments  104 . For example, the data management module  320  can determine that a particular instrument, such as the third instrument  104 ″, has the highest number of analytical failures. 
     Further, the data management module  320  can provide operator competency information. For example, the data management module  320  of the first instrument  104  may determine that the third instrument  104 ″ has the highest number of discarded samples. Such information may be useful in assessing operator performance. The operator using the third instrument  104 ″ may, in such cases, require additional training in the use of the instruments  104 . 
     Additionally, the data management module  320  can perform inventory management. For example, if the sampling member  120  employs cartridges to sample a patient&#39;s body fluid, the data management module  320  can determine the number of times the cartridge has been used and indicate when a user of the instrument  104  needs to replace the cartridge. Further, the data management module  320  of one instrument  104  (e.g., the first instrument  104 ) can determine when the cartridge supply of another instrument (e.g., the second instrument  104 ′) needs to be replaced. 
     As described above, the data management module  320  can also determine the workload of an instrument  104 . In one embodiment, the data management module  320  can determine the workload of the instrument  104  that the data management module  320  is executing on. The data management module  320  can also determine the workload of another instrument  104  communicating with the instrument  104  that the data management module  320  is executing on. For example, a user of the first instrument  104  can use the data management module  320  to determine the frequency that the third instrument  104 ″ is being used (e.g., once a day, ten times a day, etc.). The user can use this information to determine whether to remove an instrument  104  (e.g., the third instrument  104 ″) from the particular location (e.g., if the instrument  104  is not being used enough to warrant its positioning at the location), to add another instrument  104  to the same location (e.g., if the instrument  104  is being overworked) or to regulate the distribution and usage of the instruments  104 . 
     In a particular embodiment, a user can access the user interface  316  and the data management module  320  from a web browser (e.g., Internet Explorer developed by Microsoft Corporation, Redmond, Wa.). For instance, a user can use the web browser executing on a personal computer (e.g., in the user&#39;s office in the hospital) to access the data management module  320  and/or the user interface  316 . Moreover, the user interface and data management module displayed in the web browser have the same “look and feel” as the user interface  316  and data management module  320  executing on the instrument  104 . The web browser enables a remote user to perform the same functions that a user using the user interface  316  on the instrument  104  can perform. Thus, a remote user can, for instance, view a snapshot of the instrument screen display, review patient or quality control results, review the instrument&#39;s status, enable or disable analysis, enable or disable operator access, lock the instrument, calibrate the instrument  104 , and post a message on the instrument  104 . 
     Continuing to refer to  FIG. 3 , and as described above with reference to  FIG. 1 , each instrument  104  comprises a communications module  124  to facilitate inter-instrument communication. In some embodiments, the communications module  124  is an internal component of the instrument  104  that (i.e., an internal wireless network interface card, transponder, or other signal-generating device). In other embodiments the communications module  124  is an external device that, for example, can be periodically connected to the instruments  104  via an interface  328 . 
       FIG. 4  is a flow diagram of the steps performed for configuring the instruments  104  of  FIG. 1  according to an illustrative embodiment of the invention. The instruments  104  in the illustrative embodiment are connected to the network  116  so that each instrument  104  is in direct communication with one or more of the other instruments  104  (step  410 ). The sampling member  120  of the first instrument  104  then samples a body fluid from a patient (step  415 ). The first instrument  104  then analyzes the body fluid sample (step  420 ) and obtains patient data. The second instrument  104 ′ (or any other instrument  104 ) then accesses, directly from the first instrument  104 , the patient data corresponding with the analysis of the sample (step  425 ). Alternatively, the second instrument  104 ′ instructs the first instrument  104  to sample a body fluid and steps  415 ,  420 ,  425  are then started. For example, upon receipt of the instruction, the first instrument  104  samples a body fluid (e.g., blood) from a patient, as shown in step  415 . Moreover, any number of the steps shown in  FIG. 4  may occur. For instance, the first instrument  104  may only sample a body fluid (Step  415 ) and then analyze the body fluid sample (Step  420 ). Another instrument  104  may not access patient data associated with the analysis of the sample or may access the patient data after a long time delay (e.g., four days later). 
     With reference to  FIG. 5 , and in one exemplary embodiment, a laboratory technician needing a particular test, analysis, or collection of a patient sample utilizes a first instrument  104  to initiate a request for a patient sample (STEP  510 ). A doctor, nurse, or other medical technician receives the request on a second instrument  104 ′ (STEP  515 ). The request may be in the form of a screen message, audible message, or other recognizable indication that a request has been received. The medical technician may then acknowledge receipt of the request and, if no sample was previously taken (STEP  520 ) draw the patient sample using the sampling member of the second instrument  104 ′ (STEP  525 ) after which the second instrument  104 ′ then performs the requested analysis (STEP  530 ). The second instrument  104 ′ then transmits the results of the analysis (STEP  535 ) where it is received by the first instrument  104  (STEP  540 ), thereby providing the laboratory technician with the necessary data. Such requests may be made in conjunction with scheduled rounds, patient care protocols, or on an as needed (i.e., random) basis. 
     In another embodiment a medical technician tending to a patient and using a first instrument  104  requests an analysis of a previously drawn sample of the patient. At another location, such as a laboratory where multiple patient samples are stored awaiting analysis, the second instrument  104 ′ receives the request from the first instrument  104  and introduces the sampling member of the second instrument  104 ′ into the patient sample (STEP  550 ). The analysis is conducted by the second instrument  104 ′ (STEP  530 ), and the results are transmitted from the second instrument  104 ′ (STEP  535 ) back to the first instrument  104  (STEP  540 ), where the results are displayed. Alternatively, or in conjunction with this approach, the patient samples are arranged in a tray such that an automated sampling member probe of the second instrument  104 ′ extends to and selects the desired patient sample and samples the patient sample (STEP  560 ) such that the appropriate analysis of the sample directed by the first instrument  104  is conducted by the second instrument  104 ′ (STEP  530 ). 
     In another example, the second instrument  104 ′ may be connected directly to a patient via an extracorporeal device such as a blood pump used during a cardio-bypass procedure. In such cases, the sampling member of the second instrument  104 ′ is in contact with the patient sample on a frequent, or in some cases continuous basis, and requests for sampling and analysis by the first instrument  104  directed by the second instrument  104 ′ can be serviced in real-time. 
     Having described certain embodiments of the invention, it will now become apparent to one of skill in the art that other embodiments incorporating the concepts of the invention may be used.