Abstract:
The present invention provides a system and method for patient clinical data management. The system and method provide automated data gathering, processing and reporting. Test orders are generated using a patient clinical data management application and are transmitted to laboratory equipment. Test results are obtained by the patient clinical data management application directly from the laboratory equipment. Processing may be performed in conjunction with demographic and related data. Reporting is conducted in accordance with reporting requirements imposed from governmental or other regulatory bodies. Select information from the records may be provided to endpoint devices such as mobile telephones, websites, pagers or personal digital assistants for up to the minute reporting.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]    This application claims the benefit of U.S. Provisional Patent Application No. 60/372,634, filed Apr. 15, 2002 and entitled SYSTEM AND METHOD FOR PATIENT DATA MANAGEMENT, the entire disclosure and appendices of which are hereby expressly incorporated by reference. 
     
    
     
       FIELD OF INVENTION  
         [0002]    The present invention relates to medical diagnostics. More particularly, the present invention provides a system and method for patient clinical data management. The system and method are suitable for data collection, diagnostics, analysis, reporting and connectivity to applications across distributed networks.  
         BACKGROUND OF THE INVENTION  
         [0003]    In the past, medical professionals such as physicians, nurses and laboratory technicians used paper charts to track a patient&#39;s history and status. More recently, such professionals have moved away from relying on paper charts. Instead, electronic medical records (“EMR”) and computer-based patient records (“CPR”) are used more and more to leverage all available information to improve medical care.  
           [0004]    EMR and CPR records are also known as electronic patient records (“EPR”), virtual patient records (“VPR”) and electronic health records (“EHR”). Regardless of the acronym, these records supplement or totally replace paper charts and records. Medical information systems (“MIS”) use EMR and CPR to maintain up-to-date, robust patient information while reducing the time, labor and other costs associated with managing such data.  
           [0005]    Often, data is manually input into EMR and CPR systems, which can prove costly and time-consuming. Such systems may have hundreds or thousands of fields of data per patient record, depending upon, e.g., the physician&#39;s area of specialty. For example, a physician involved with assisted reproductive technology (“ART”) may use an EMR or CPR database having on the order of 5,000 fields per record. The fields may include, by way of example only, patient data, laboratory results and treatment information.  
           [0006]    In order to fully leverage information stored in the database, it is critical that it be easy to enter, process, retrieve and export the data. Once this is achieved, medical professionals and patients will benefit from current information to achieve better decision-making. Therefore, it is desirable to implement an information system having enhanced inputting, processing and reporting capabilities.  
           [0007]    Reporting is important not only for internal use by medical professionals, but also as part of an external procedure that a governmental body or medical society may mandate. Reporting includes generating reports and charts, and formatting data so that a medical professional using the system can analyze the data. It also encompasses producing electronic records that are sent from the system to an external entity. For example, the 1992 Fertility Clinic Success Rate and Certification Act, codified at 42 U.S.C. § 263a-1 et seq., requires ART clinics to report certain fertility-related information to the Centers for Disease Control and Prevention (“CDC”). ART clinics provide data to the CDC through a reporting system of the Society for Assisted Reproductive Technology (“SART”). This system is known as the Clinical Outcome Reporting System (“CORS”).  
           [0008]    SART CORS allows ART clinics (e.g., fertility clinics) to automate the reporting process. The reported information is extensive, and includes patient information, patient history, diagnosis, donor and retrieval data, embryo transfers and delivery information. Detailed information about the SART CORS system may be obtained from SART or from Redshift Technologies, Inc., which has implements a SART CORS Import Gateway.  
           [0009]    In practice areas, particularly those with heavy regulation and/or detailed reporting requirements, it is important that the patient database and underlying information system are capable of interfacing with off-the-shelf applications and generating standard reports without undue modification. Therefore, it is desirable to provide an enhanced system and method to achieve these goals.  
         SUMMARY OF THE INVENTION  
         [0010]    In accordance with one embodiment of the present invention, a computer-implemented method for managing patient clinical data is provided. The method comprises interfacing a central computer with laboratory equipment. The central computer has access to patient clinical data stored in a patient information database. The laboratory equipment is operable to generate test results based on medical tests. The test results are received from the laboratory equipment at the central computer. The test results are stored as a test results portion of the patient clinical data in the patient information database. A subset portion of the patient clinical data, including data from the test results portion, is selected in accordance with predetermined selection criteria. The selected subset portion of the patient clinical data is reported to a reporting device. Preferably, interfacing further includes sending a request to conduct the medical test from the central computer to the laboratory equipment. The laboratory equipment may be controllable by a client computer which is remote from the central computer and the laboratory equipment. The client computer may receive the test results, and then transfer the test results to the central computer.  
           [0011]    In one example, the predetermined selection criterion is identified using one of several selections, including a user-generated selection, a system-generated selection, or a by-directional selection. Preferably, the test results include endocrine tests results for use in fertility treatment. More preferably, the subset portion includes endocrine data from the endocrine test results. The method preferably further comprises associating partner information with the patient clinical data such that a patient in the patient information database is linked with a partner. Thus, the user can thereby obtain a report and document treatment for the patient and for the partner. In another alternative, the predetermined selection criterion is a SART-compliant format, and the subset portion of the patient clinical data is reported according to the SART-compliant format. In another alternative, the method further comprises obtaining back office information from a back office server. The back office information is incorporated as a second portion of the patient clinical data in the patient information database. In this alternative, the subset portion further includes at least a portion of the back office information.  
           [0012]    In accordance with another embodiment of the present invention, a computer implemented method for managing patient clinical data is provided. The method includes sending a request to conduct a medical test from a central computer to laboratory equipment that is used in connection with patient testing. A central computer has access to the patient clinical data that is stored in the patient information database. The central computer receives test results from the laboratory equipment. The test results are based on the medical test. The test results are stored as a test results portion of the patient clinical data in the patient information database. A subset portion of the patient clinical data, including data from the tests results portion, is selected in accordance with predetermined selection criteria. A report of the selected subset portion of the patient clinical data is also generated. In one alternative, the medical test is test on a patient sample. In another alternative, the medical test is a batch of tests on a patient sample. In a further alternative, the medical test is a test on a plurality of patient samples. In yet another alternative, the medical test is a batch of tests on a plurality of patient samples. Preferably, the predetermined selection criterion is identified using one of a user-generated selection, a system-generated selection or a by-directional selection. The test results preferably include endocrine tests results for use in fertility treatment.  
           [0013]    The report may be generated for a computer remote from the central computer, or for a wireless device. Alternatively, the report is electronically sent to a reporting device. Preferably, the report is generated in a SART-compliant format and the reporting system is a SART reporting system.  
           [0014]    In accordance with another embodiment of the present invention, a system for managing patient clinical data is provided. The system comprises a patient information database, laboratory equipment and a central computer. The patient information database is for storing patient clinical data. The laboratory equipment is used in connection with patient testing. It is operable to perform a medical test and generate test results based on the medical test. The central computer is in communication with the laboratory equipment. The central computer includes a patient clinical data management program or application, which is capable of obtaining the test results from the laboratory equipment and performing other operations. These operations include storing the test results as a test results portion of the patient clinical data in the patient information database. The program also selects a subset portion of the patient clinical data, including data in the test results portion, in accordance with predetermined selection criteria. Furthermore, the subset portion of the patient clinical data is transmitted to a recording device. The central computer preferably includes an application server for running the patient clinical data management program. The system preferably further comprises a client computer operable to access the patient clinical data management program by connecting to the application server. Preferably, the client computer receives the test results from the laboratory equipment, and the client computer is operable to transfer the test results to the patient clinical data management program. The client computer is remote from the laboratory equipment and the central computer.  
           [0015]    The test results preferably endocrine test results are used for fertility treatment. optionally, the reporting device is an endpoint device operable to interface with the central computer and receive the subset portion of the patient clinical data. The endpoint device may be a computer, a personal digital assistant, a wireless telephone, a pager or a website. In one alternative, the system further comprises a back office server for managing back office information related to patient records. The back office server is capable of providing the back office information to the central computer for use by the patient clinical data management program. In this alternative, the patient clinical data management program is operable to incorporate the back office information as a second portion of the patient clinical data in the patient information database. The subset portion, in this case, further includes at least a part of the second portion of the patient clinical data. In another alternative, the patient clinical data management program is capable of coupling partner information with the patient clinical data such that patients in the patient information database are properly associated with partners. In a further alternative, the system further comprises a CORS reporting system. In this case, the patient clinical data management application is capable of transmitting the subset portion to the CORS reporting system in a SART-compliant format.  
           [0016]    In a further embodiment of the present invention, a system for managing patient clinical data is provided. The system comprises a patient information database, laboratory equipment and a central computer. The patient information database stores the patient clinical data. The laboratory equipment is used in connection with patient testing and is operable to perform medical tests and generate test results based on the medical test. The central computer is in communication with the laboratory equipment. It has access to the patient information database and it includes a patient clinical data management program that is capable of sending a request to conduct the medical test to the laboratory equipment. The patient clinical data management program is also capable of receiving the test results from the laboratory equipment, storing the test results as a test results portion of the patient clinical data of the patient information database, selecting a subset portion of the patient clinical data, including data from the test results portion, in accordance with predetermined selection criteria, and is capable of generating a report of the selected subset portion of the patient clinical data. Preferably the central computer includes an application server for running the patient clinical data management program. The system in this case further comprises a client computer operable to access the patient clinical data management program by connecting to the application server. In an alternative, the client computer receives the test results from the laboratory equipment. In this situation the client computer is operable to transfer the tests results to the patient clinical data management program. The client computer is remote from the laboratory equipment and the central computer.  
           [0017]    Preferably, the test results include endocrine test results for use in fertility treatment. In one example, the reporting device is an endpoint device, which is able to interface with the central computer and receive the subset portion of the patient clinical data. The endpoint device may be a computer, a personal digital assistant, a wireless telephone, a pager or a website.  
           [0018]    Optionally, the system may further comprise a back office information server for managing back office information related to patient records. The back office information server is capable of providing the back office information to the central computer for use by the patient clinical data management program. The patient clinical data management program is operable to incorporate the back office information as a second portion of the patient clinical data in the patient information database. In this alternative, the subset portion further includes at least part of the second portion of the patient clinical data.  
           [0019]    In another alternative, the patient clinical data management program is capable of coupling partner information with the patient clinical data such that patients in the patient information database are correctly associated with partners. In another alternative, the system further comprises a CORS reporting system. Here, the patient clinical data management program is capable of transmitting the subset portion of the patient clinical data to the CORS reporting system in a SART-compliant format.  
           [0020]    In another embodiment of the present invention, a computer-usable storage medium is provided. The storage medium stores a program capable of instructing a processor to execute certain actions. An action is interfacing a central computer with laboratory equipment. The central computer has access to patient clinical data stored in a patient information database. The laboratory equipment is operable to generate test results based on medical tests. Another action is the central computer receiving the test results from the laboratory equipment. A further action is storing the test results as a test results portion of the patient clinical data in the patient information database. The actions also include selecting a subset portion of the patient clinical data, including data from the test results portion, in accordance with predetermined selection criteria. Yet another action is reporting the selected subset portion of the patient clinical data to a reporting device.  
           [0021]    In accordance with another embodiment of the present invention, a computer-usable storage medium is provided. The storage medium stores a program capable of instructing a processor to execute certain actions. One action is sending a request to conduct a medical test from a central computer to laboratory equipment that is used in connection with patient testing. The central computer has access to patient information stored in a patient information database. Another action is receiving test results at the central computer from the laboratory equipment. The test results are based on the medical test. A further action is storing the test results as a test results portion of the patient clinical data in the patient information database. Another action is selecting a subset portion of the patient clinical data, including data from the test results portion, in accordance with predetermined selection criteria. Yet another action is generating a report of the selected subset portion of the patient clinical data. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0022]    [0022]FIG. 1 illustrates a diagram of a medical information system in accordance with an embodiment of the present invention.  
         [0023]    [0023]FIG. 2 illustrates a user-generated order system GUI.  
         [0024]    [0024]FIG. 3 illustrates a graphical user interface (“GUI”) for sending a laboratory test.  
         [0025]    FIGS.  4 A-B illustrate GUIs for generating barcode labels for use with medical testing.  
         [0026]    [0026]FIG. 5 illustrates a GUI having color-coded laboratory test results.  
         [0027]    FIGS.  6 A-B illustrate GUIs for displaying received laboratory test results.  
         [0028]    [0028]FIG. 7 illustrates an example of a medical report in accordance with the present invention.  
         [0029]    [0029]FIG. 8 illustrates a GUI for sending real-time messages pertaining to laboratory test results.  
         [0030]    [0030]FIG. 9 illustrates a diagram of a medical information system in accordance with another embodiment of the present invention.  
         [0031]    FIGS.  10 A-D illustrate GUIs for patient demographic information.  
         [0032]    FIGS.  11 A-C illustrate GUIs pertaining to patient history and treatment.  
         [0033]    FIGS.  12 A-B illustrate exemplary reports generated in accordance with the present invention. 
     
    
     DETAILED DESCRIPTION  
       [0034]    The present invention will now be described in relation to the figures, wherein like numerals represent like elements. FIG. 1 illustrates a system  100  in accordance with one embodiment of the present invention. The system  100  includes an application server  102 , a patient information database  104 , laboratory equipment  106 , a local computer  108 , remote computers  114  and  116  and an endpoint device  120 . The local computer  108  may be remote from the application server  102  and may connect to it through an Intranet  110  or other well-known methods. As used herein with regard to computers and other devices, being “remote” from equipment, e.g., the application server  102  or the laboratory equipment  106  means physically separate from the equipment. The devices may be in communication with the equipment either wirelessly or via a wired connection and still be considered remote from that equipment. The remote computers  114  and  116  may connect to the application server  102  through the Internet  112  or through other means such as private networks, direct dial-in, etc. The remote computers  114  and  116  may be associated with one another or may operate separately as in, for example, one or more medical clinics. The endpoint device  120  preferably connects to the application server  102  via a network  118 , which may be a wired or wireless network. Although only a few computers and devices are depicted in FIG. 1, it should be appreciated that a typical system  100  can include a large number of connected computers and devices.  
         [0035]    Preferably, the local computer  108  and the remote computers  114  and  116  are general-purpose computers having all the internal components normally found in a personal computer. More preferably, the local computer  108  and the remote computers  114  and  116  are capable of supporting a window-based graphical user interface (GUI). The local computer  108  and the remote computers  114  and  116  may communicate using a modem or other communication components such as a network card, including a wireless LAN card. The endpoint device  120  may comprise any device capable of processing instructions and transmitting data to and from humans and computing devices, such as a personal digital assistant (“PDA”), wireless telephone (e.g., a cellular or PCS-frequency telephone), pager, website, handheld or portable computer and the like.  
         [0036]    The application server  102  contains software and hardware for sending and receiving information over the Internet and other networks. The application server  102  may be a conventional application server or any computer network server or other automated system capable of communicating with other computers over a network. The application server  102  may comprise one or more distributed processors.  
         [0037]    In one alternative of the invention, the application server  102  contains a patient clinical data management application or program resident in memory of the application server  102 . The terms application and program are used interchangeably herein. The application preferably operates on data stored in the patient information database  104 . The functions, methods and routines of the application are explained in detail below. It should be appreciated that certain actions of the application may be performed in different order.  
         [0038]    The patient information database  104  may be included with or remote from the application server  102 . Although the invention is not limited to any particular database structure, the data maintained by the patient information database  104  may be stored as a table having a plurality of different fields and records. For example, a patient record may have hundreds or thousands of fields. Each patient record may be indexed and stored according to one or more fields in the record, such as the patient&#39;s last name. Alternatively, the data may also be stored using completely different methods of storing information such as XML or the like.  
         [0039]    The laboratory equipment  106  may include one or more pieces of equipment, including diagnostic equipment. The laboratory equipment  106  may be, for example, standard medical equipment such as an EKG or EEG machine. The laboratory equipment  106  is preferably capable of generating test results, including laboratory data associated with a patient. In a preferred embodiment, the laboratory equipment  106  provides test results on tissue or other samples for use in a medical specialty. For example, in a system intended for use with fertility treatment, the laboratory equipment  106  is preferably capable of performing endocrine-related testing. By way of example only, one type of such laboratory equipment  106  is the IMMULITE® 2000, provided by Diagnostic Products Corporation. The IMMULITE® 2000 is capable of performing up to 200 tests per hour and supports remote ordering of tests. The laboratory equipment  106  includes hardware for sending and receiving information over the Internet or other networks, and is preferably capable of interfacing with the patient clinical data management application through the application server  102 , the local computer  108  and the remote computers  114  and  116 .  
         [0040]    The patient clinical data management application preferably interfaces with the laboratory equipment  106  in one of the following manners. In a first alternative, the “system-generated option,” the patient clinical data management application automatically generates orders for the laboratory equipment  106  based upon user input. In a second alternative, the “user-generated option,” a user such as a medical practitioner operates the patient clinical data management application to generate orders, e.g., test requests, for the laboratory equipment  106 . As a general matter, users may access the application through remote computers  114  and  116 , local computer  108 , or directly at the application server  102 . Optionally, a user may access the application from the endpoint device  120 , which may be, e.g., a two-way pager or PDA with access to the Internet. As a preferred example, the patient clinical data management application includes a GUI accessible by the users. In a third alternative, the “bi-directional option,” all data entry into the laboratory equipment  106  is automated. Each alternative will now be explained in more detail.  
         [0041]    In the system-generated option, the user enters an order request into the patient clinical data management application. The application automatically generates the order. The order is manually entered at the laboratory equipment. Once the laboratory equipment  106  generates test results, the laboratory equipment  106  interfaces directly with the application server  102  to provide the test results to the patient clinical data management application. As mentioned above, in this option the application automatically generates orders for use by the laboratory equipment  106 . These orders may include, by way of example only, requests to perform specific tests. Because the application generates orders without user entry, there is an increase in efficiency and a reduction of potential typographical errors. Users may access the test results, and are able to generate reports, medical charts and graphs. Furthermore, users may view released and unreleased information related to test orders. Released information includes test results provided by the laboratory equipment  106  to the patient clinical data management program, while unreleased information includes data that is also provided by laboratory equipment, but may not be accessible to certain users. In the case where the laboratory equipment  106  generates endocrine results, users may view released and unreleased endocrine values.  
         [0042]    The user-generated option allows users to control input to the laboratory equipment  106  and tailor the information as desired. Users may perform one or more of the following exemplary actions in the user-generated option: place an order, input an individual test request, order a panel of tests, delete an order, verify that an order is placed, view historical laboratory data by specific patient, place a “provisional” order, convert a provisional order and work with an unreleased view. A provisional order is a test to be performed at a later or unknown date. Test results are sent from the laboratory equipment  106  to the application in the same manner as in the system-generated option, e.g., manually input into the laboratory equipment  106 . Once the test results are ready, the user manually retrieves the test results from the laboratory equipment  106  and enters the information into the patient clinical data management program.  
         [0043]    [0043]FIG. 2 illustrates a graphical user interface (GUI) screen-shot  200  of a program used for user-generated ordering of tests. As shown on the left hand side of the GUI, a user may select an individual test from among the choices provided in the left column  202 . Once selected, the test is moved into the center column  204  of the GUI  200 , entitled “Selected Tests.” As an alternative, the user may select a group, or panel of tests from the right hand column  206  of the GUI  200 . Optionally, the user may select one or more individual tests from among the panels of tests. The requesting doctor is identified by “Req&#39; MD” field  208 . The user may select a patient or her partner in “Select Person” field  210 . More details about coupling patient and partner information will be provided below. Preferably, the user may select one or more patients. Selecting check box “Create Provisional Order”  214  places a provisional order. The date of the provisional or actual order is entered via “Date” field  212 . Any comments, such as an explanation of a provisional order, may be entered in the text box labeled “Comments”  216 .  
         [0044]    Tests ordered during the same transaction are preferably automatically grouped in the same panel identifier (“Panel ID”). Tests ordered in different transactions are preferably grouped in different Panel IDs. FIG. 3 illustrates a sample GUI screen  300  for a panel of orders ready to send to the laboratory equipment  106 . Clicking on “Send All” button  302  causes the application to transmit the order for the selected test(s) to the laboratory equipment  106 .  
         [0045]    The bi-directional option eliminates the need for manual data entry into the laboratory equipment  106  when an order is generated using the patient clinical data management application. Once the user places the order request in the system, the bi-directional process is totally automatic. The order is automatically generated and provided to the laboratory equipment by the patient clinical data management program. As with the system-generated option, when the test results are ready, the laboratory equipment  106  interfaces directly with the application server  102  to provide the test results to the patient clinical data management application.  
         [0046]    The application may print barcode labels or similar identifying labels when generating an order, or such labels may be printed at a later time based on user workflow needs. Barcode labels eliminate two manual functions. One function is the manual creation of a test tube label. The other function is manual order entry into lab equipment. With the barcode label, the laboratory equipment  106  reads the order from the barcode label and compares it to the data from the patient clinical data management application for validity. All labels, barcode or otherwise, in all cases, are preferably selection options and are affixed either to a specifically required. submission object (e.g., a test tube) or other designated object that requires labeling.  
         [0047]    [0047]FIGS. 4A and B illustrate GUIs  400  and  420  for generating barcode labels. As shown in the GUI  400  of FIG. 4A, the user may print one or more labels by selecting the option “Batch Barcodes”  402 . The option “Print Labels”  404  is used to print the labels. As shown in FIG. 4B, the GUI  420  is provided after selecting Print Labels  404 . Here, the user may input the number of labels using the “No. of Labels per Test”  422  entry box. The user may also select which tests to run in batch mode by placing a check mark next to the appropriate tests as shown by arrow  424 . Barcode labels may be printed for every patient displayed in the window by choosing the “Select All” button  426 .  
         [0048]    The bi-directional option has the same benefits of the automated system-generated option, particularly increasing efficiency by avoiding user input of received test results from the laboratory equipment  106 . Furthermore, this option permits automated distribution of results to, e.g., the remote computers  114  and  116 , the local computer  108  or to the endpoint device  120 . Because the bi-directional option employs barcode labels, it further enhances gathering, processing and reporting of data. This option allows grouping of panels of tests ordered at different times, and may use color-coding as part of a GUI display to increase workflow efficiency. For example, FIG. 5 illustrates a GUI  500 , wherein, when new results are received from the laboratory equipment  106 , a color-coded identifier  502  changes color from an initial color  504 . While the initial color  504  and the color-coded identifier  502  are shown using shading, any color or color combination, including shading and the like may be used. Thus, a user may readily identify receipt of new test results and act accordingly. The process status field  506  provides the tests ordered, the tests sent and the tests received, so that a user may know the current testing status.  
         [0049]    Once the laboratory equipment  106  performs the test(s), results are sent back to the patient clinical data management application. Regardless of the option used to generate an order/test, the user is able to view the information received from the laboratory equipment  106 . The test results/laboratory data may encompass a wide variety of information. Some of the information pertaining to the results may be provided from the laboratory equipment  106  to the patient clinical data management application, while the laboratory equipment  106  may not transmit other portions of the information. This information may not need to be transmitted because the patient clinical data management application may, e.g., already have such information stored in the patient information database  104 .  
         [0050]    [0050]FIG. 6A illustrates a GUI  600  for viewing test results. In the present exemplary snapshot for the GUI  600 , the test results are endocrine-related test results for use in fertility testing. By way of example only, the information sent to the patient clinical data management application preferably includes fields for the viewing date  602 , the patient name  604 , an accession number (“Acc. #”)  606 , a master patient index (“MPI”) number  608 , the name of the test (“Type”)  610 , the test result (“Value”)  612 , unit of measurement (“Unit”)  614 , test date  616  and test time  618 . The accession number  606  is a system-assigned sequence number for handling the test result, which the laboratory equipment  106  may generate. The MPI number  608  serves as a unique patient identifier. The name of the test  610  may be an acronym such as E2 (Estradiol), P4 (Progesterone), LH, TSH, FSH, HCG etc. The unit of measurement  614  may be, e.g., pg/ml. The test date  616  is the date the test was run and the result released to the patient clinical data management application. The test time  618  is the time the result was completed on the lab equipment  106 .  
         [0051]    As noted above, some of the information pertaining to a particular test result may not be shared with certain users of the patient clinical data management application. Such information may include the laboratory name  620 , the assay technician  622 , whether information was released  624 , the patient&#39;s primary doctor  626 , the requesting doctor  628  and the primary nurse  630 .  
         [0052]    Optionally, the patient clinical data management application provides users with an historical view of test results. FIG. 6B illustrates an historical view GUI  640 . In one alternative, the historical view GUI  640  is read only. Similar to the GUI  600 , the GUI  640  provides the patient name  604 , the accession number  606 , the Type  610 , the Value  612  and the test date  616 . The GUI  640  may also provide the order date  642  of the test, any comments  644 , the reviewer  646  (if any) of the test results, and the requester  648  of the test(s).  
         [0053]    After the patient clinical data management application receives test results from the laboratory equipment  106 , the user or the application itself may generate a report or a chart based on the received results. FIG. 7 illustrates an exemplary report of fertility-related test results. A user may also provide a real time message regarding test results to another user operating the endpoint device  120 , the local computer  108  or one of the remote computers  114  and  116 . FIG. 8 illustrates an exemplary GUI  800  wherein the user may select a recipient  802 , enter a message  804  or read a message  806  from the other party.  
         [0054]    [0054]FIG. 9 illustrates a system  900  in accordance with another embodiment of the present invention. The system  900  includes many of the components of the system  100 , having the same functionality as described above. For example, the system  900  includes an application server  902 , a patient information database  904 , laboratory equipment  906 , a local computer  908 , remote computers  914  and  916  and an endpoint device  920 . The local computer  908  may connect to the application server  902  through an Intranet  910 . Similarly, the remote computers  914  and  916  may connect to the application server  902  through the Internet  912 . The remote computers  914  and  916  may be associated with one another or may operate separately as in, for example, one or more medical clinics. The endpoint device  920  preferably connects to the application server  902  via a network  918 , which may be a wired or wireless network. Furthermore, the system  900  also includes a back office server  940  and a CORS reporting system  930 .  
         [0055]    The back office server  940  may contain hardware for sending and receiving information over the Internet and other networks. The back office server  940  may be a conventional application server or any computer network server or other automated system capable of communicating with other computers over a network. The back office server  940  may comprise one or more distributed processors.  
         [0056]    The back office server  940  is capable of handling “back office” functionality for billing, financing, insurance, demographic and other non-medical information related to patient information (“back office information”). For example, FIGS.  10 A-D illustrate exemplary GUI screens  1010 ,  1020 ,  1030  and  1040 , respectively, pertaining to demographic information. As shown in FIG. 10A, the GUI  1010  includes key identification information about a patient and her partner, such as full name, address, social security number (“SS #”), MPIs for the patient and the partner, date of birth (“DOB”) of the patient, race, etc. The GUI  1020  of FIG. 10B includes additional information such as home and work telephone numbers, which clinic or doctor&#39;s office serves the patient, and couple related information, such as whether they are married. The GUIs  1030  and  1040  contain supplemental information, including the referring physician, employment data and insurance information.  
         [0057]    The back office server  940  preferably connects to the application server  902  directly in a point-to-point fashion, e.g., cabled together. More preferably, all demographic, insurance and referral data flow from the back office server  940  to the patient clinical data management application in this point-to-point fashion. The back office server  940  preferably includes back office application software to process the information. More preferably, the back office application software includes a financial application for processing at least the billing and other financial data. The back office server  940  may include a database for storing information pertaining to non-medical information. The back office application software is capable of exporting some or all of the back office information to the patient clinical data management application, which may store the back office information in the patient information database  904 . Preferably, the back office information in the patient information database  904  is stored in such a way as to be associated with the patient information. The patient clinical data management application is preferably able to generate reports, charts and the like using the patient information, including any test results, as well as the back office information. For example, FIG. 12A illustrates an exemplary report  1200  detailing embryo implantation as a function of age, and FIG. 12B illustrates a statistical analysis  1210  for multiple pregnancy rates sorted according to various baseline criteria.  
         [0058]    In one alternative, the patient clinical data management application is capable of coupling partner records with patient clinical data in the patient information database  904 , as shown in FIGS.  10 A-B. Coupling is important in many situations, such as generating a patient&#39;s chart. For example, when the system  900  is used in conjunction with a fertility clinic, a partner record may include information pertaining to the patient&#39;s husband, such as any infertility issues he may have encountered. Thus, after coupling a partner record with a specific patient&#39;s data, a user will be able to access information and document treatment for the patient and her partner on the patient clinical data management program.  
         [0059]    The CORS reporting system  930  is preferably a server or other computer capable of reporting ART-related information to the CDC. The patient clinical data management application of the application server  902  preferably generates the ART-related information in a SART-compliant format based upon the information in the patient information database  904 . The SART-compliant format may be the format defined by SART CORS, as is known in the art. For example, the patient clinical data management application may report SART-required ART data using a patient data table and a cycle table (e.g., a pregnancy cycle table). The SART-compliant information is preferably exported from the application server  902  to the CORS reporting system  930 , which in turn provides this information to the CDC. Optionally, the CORS reporting system  930  may be integrated as part of the application server  902 , or it may be an application resident on the application server  902 .  
         [0060]    FIGS.  11 A-C relate to SART information dealing with patient history, treatment and other ongoing activities. FIG. 11A illustrates a GUI  1100  for handling additional back office information related to patient history. In the case where the system  900  pertains to a fertility clinic, the GUI  1100  may include information concerning prior pregnancies or infertility problems, diagnoses and treatments. Similarly, FIG. 11B illustrates a GUI  1110  for stimulation management and related research. This information pertains to drug protocols for production of eggs or for transfer of embryos. FIG. 11C provides various options pertaining to infertility treatment, such as embryo fertilization, retrieval, freezing and thawing.  
         [0061]    One advantage of the present invention is the use of multiple processes to generate test orders, automatically send the test orders to laboratory equipment and automatically receive test results from the laboratory equipment. Another advantage of the present invention is the use of barcode labels tied directly with the automatic ordering of tests and the processing of test results. Yet another advantage of the present invention is the ability to distribute test results to users at local computer, remote computers and endpoint devices upon receipt by the patient clinical data management application. A further advantage of the present invention is the ability to integrate back office data with patient clinical data to effectively manage patient records. Yet another advantage of the present invention involves using the patient clinical data management program to generate and transmit ART data in a SART-compliant format in order to comply with reporting requirements.  
         [0062]    Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.