Abstract:
A system for capturing and maintaining a categorized flow of data in a clinical environment includes a distributed computer network, a plurality of data clusters dispersed over the network, a repository adapted to store data representative of the identity of patients, means for querying the repository to identify one of the data clusters associated with a particular patient and in response to such identification of the data cluster, allowing said particular patient or a user to query clinical data associated with the patient from said identified data cluster.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS  
       [0001]     This application claims priority of U.S. Provisional Patent Application Ser. No. 60/535,390, filed on Jan. 9, 2004. 
     
    
     FILED OF THE INVENTION  
       [0002]     This invention is in the field of medical information systems, and more particularly related to optimized methods and systems for capturing and maintaining a categorized flow of data in a clinical environment  
       BACKGROUND OF THE DISCLOSURE  
       [0003]     Clinical data is defined as data related to a patient. It includes data such as ADT, vital signs, analog waves, summaries, and the like. Clinical data is categorized by the patient; each patient has its own data. Clinical data is collected from various sources, such as medical devices, and hospital systems or may be manually entered by clinical staff. This can result in a huge amount of data flow that needs to be captured online. The clinical data, once captured, should be available for browsing, manipulating and query. In order to achieve high-performance for such issues (browsing/queries/manipulating),the data store (that is, the physical file itself where the data is kept) should have as small a size as possible (one that fits the machine hardware) and yet maintain all the patient data in the same store (to avoid the need for cross-file queries). Having multiple storages (for example, separate stores for each patient) can pose a maintenance problem. In addition, for the method of capturing and maintaining clinical data to be scalable, it should be possible to add additional hardware to handle parts of the clinical data flow. This invention provides a load balancing system and method for capturing clinical data, while keeping the number of physical data stores, and their size, low as possible.  
       SUMMARY OF THE INVENTION  
       [0004]     The system and method of the invention establishes a data base architecture that is particularly suited for entry, storage, management and access for clinical data in a critical care and/or more general hospital environment. The system and method of the invention is preferably operative over a geographically distributed network including multiple servers, data stores and user access terminals, but could alternatively be operative over a local area network. In one form, communication between network nodes can be effected over the internet.  
         [0005]     In accordance with the invention, the database architecture includes a plurality of data stores referred to as Data Clusters. Each Data Cluster may store medical record data for predetermined number of patients. By way of example, the data stored for a patient at a Data Cluster may include heart rate data, body temperature data, diagnosis code data, demographic data as well as other data typically used in critical care and/or more general hospital environments. The amount of the data stored for various patients in a Data Cluster may vary from patient to patient. There may be clinical data that is representative of frequent data points over a short time period, or less-frequent data points over a long time period. Preferably, the Data Clusters are each associated with a particular server in the network. Each such server may be associated with zero, one or more Data Clusters.  
         [0006]     A Repository is employed to maintain, in effect, a table of information which includes meta-data for each Data Cluster. The meta-data for a Data Cluster is representative of the identity of each patient for whom medical data records are stored on the Data Cluster, and of the type (and in some cases, the range) of data values stored at the Data Cluster.  
         [0007]     The database architecture is accordingly structured so that a user of the system and method of the invention, may desire, for example, to obtain temperature and heart rate data for a particular patient over a certain time period. To obtain this information, the user may, at a user terminal, communicate his desire to the Repository. The Repository, in response, scans the meta-data, and identifies the user, the identity of the Data Cluster in which the desired information is stored, as well as ranges for the data values, if applicable. The user can then query over the network, the particular Data Cluster. In response to such queries, the queried Data Cluster returns the requested data to the user at his terminal. The user terminal may be for example a desktop computer hardwired to the network, or may be a wireless handheld computer, or some other conventional device.  
         [0008]     With the above described architecture, standard procedures and protocols for medical data are applied to the data and communication of the same so that requisite privacy, security and integrity are maintained. A principal advantage of the system and method of the invention, is the establishment of a distributed database that permits easy, fast and efficient queries for clinical data in a critical care and/or more general hospital environment, particularly when compared with clinical data systems of the prior art. 
     
    
     DESCRIPTION OF THE DRAWINGS  
       [0009]      FIG. 1  shows, in block diagram form, a clinical data system in accordance with the invention. 
     
    
     DESCRIPTION OF THE PREFERRED EMBODIMENT  
       [0010]     A clinical data system  10  of the present invention is shown in  FIG. 1 . The system and method of the invention establishes a data base architecture that is particularly suited for entry, storage, management and access for clinical data in a critical care and/or more general hospital environment. The system and method of the invention is preferably operative over a geographically distributed network  100  including multiple servers  110 , data stores  300  and user access terminals  400 , but could alternatively be operative over a local area network. In one form, communication between network nodes  120  can be effected over the internet.  
         [0011]     A Data Cluster  200  is a categorized storage location, that holds information for certain sets of categories (that is, patients). A master index establishes a patient-cluster relationship. The system/method directs clinical data flow for each patient to his/her respective Data Cluster. The content of the Data Cluster is described in an external file—referred to as the Repository  300 . The Repository  300  includes meta-data that describes the content of all the Data Clusters. This Data Cluster-Repository approach allows a reduction in storage requirements and is easier to maintain, compared to prior art approaches. The Data Cluster size can be selected, based on various parameters such as: maximum number of patients, registration date, and the like. Each Data Cluster  200  is classified by a status, “Active” or “Non-Active”. Once a Data Cluster  200  reaches its pre-defined limit, it changes status from Active(wherein it may accept new patients) to Non-Active (wherein it may not accept new patients), and a new Data Cluster is created with the status Active. Several Data Clusters can be present on a single server in a multi-server environment, wherein one of the Data Clusters on that single server is Active. By establishing predetermined fixed sizes to the Data Clusters, the storage loading on the various servers in the multi-server environment can be balanced between the Active Data Clusters on the various servers. This architecture allows system administrator to configure a solution that best fits the hardware capabilities.  
         [0012]     In a preferred form of the invention, the various components have the following form:  
         [0000]     Repository:  
         [0013]     Description:  
         [0014]     The Repository  300  is a single hospital-wide database that enables users of the system to locate and understand the clinical data in the patient-centric Data Clusters.  
         [0015]     The repository mainly includes Meta-Data, principally in the form of data representative of patient identifications and characteristics of the clinical data.  
         [0016]     Clinical data collected from different sources (medical devices/hospital systems/medical communications devices) and different locations (hospital units) all are associated with the same repository. With this approach, the disparate patient data are available (i.e., accessible) and understandable (i.e., in an expected, and usually standard, form) regardless of the Data Cluster they are in, while keeping the “size” of the Data Clusters size relatively small (preferably, the Data Clusters may only contain pointers to the Meta-Data in the Repository, and not the Meta-Data itself).  
         [0017]     Repository Content:  
         [0018]     Cluster Index—A list of all Data Clusters in the system and the physical locations of the respective Clusters.  
         [0019]     Patient Master Index—Data representative of the particular Data Clusters on which the data for the respective patients are resident. The Patient Master Index data supports the EMPI (Enterprise master patient index) standard.  
         [0020]     User and Permissions Table—Data associated with the system users (consistent with the HIPPA requirements).  
         [0021]     Meta-Data—Data defining all the clinical data resources and their characteristics. For example: the ‘Heart Rate’ resource has the ‘Normal Values Range’ characteristic (can accept value between 50-180) and the identification number—576.  
         [0000]     Data Cluster:  
         [0022]     Description:  
         [0023]     The Data Cluster  200  is a data store where the patient clinical data is saved.  
         [0024]     Each Data Cluster  200  can support a customized number of patients, consistent with the hardware.  
         [0025]     Data in the Data Cluster, that is collected from various sources, supports the HL7 standards.  
         [0026]     All of the data for a single patient resides in a single cluster (a single patient&#39;s data can not be present in more than a single Data Cluster).  
         [0027]     Content:  
         [0028]     Patient identifier  
         [0029]     Admissions list  
         [0030]     Demographic data (e.g.: patient name, address)  
         [0031]     Diagnosis (e.g.: problem list, ICD 9/10)  
         [0032]     Vital signs data (e.g.: temperature, blood pressure, heart rate, etc)  
         [0033]     Analog wave data (e.g.: ECG)  
         [0034]     Running orders  
         [0035]     Care plans  
         [0036]     Any other clinical data  
         [0000]     Workflow example:  
         [0037]     Steps for locating patient clinical data:  
         [0038]     A user wants to check if the Body Temperature value of patient ‘John Doe’ at 11:15 PM was out of the normal range. 
        1) User issues Query to the Repository&#39;s ‘Patient Master Index’ to identify the Data Cluster upon which ‘John Doe’ data resides.     2) User issues Query to the Repository&#39;s ‘Cluster Index’ to identify the physical location of the identified Data Cluster.     3) User issues Query to the Repository&#39;s Vital Signs Meta-data to determine the ‘HR’ identification and ‘Normal Values Range’.     4) User locates the identified Data Cluster as described in the Repository&#39;s ‘Cluster Index’.     5) User issues Query to the located Data Cluster, requesting the Vital Signs patient data, using the Repository&#39;s patient identifier and the ‘HR’ identification.     6) User receives the requested patient data value, as sent by the Data Cluster, and Compares the retrieved value with the ‘Normal Values Range’ meta-data that was retrieved from the Repository. 
 
 Medical standards and regulations: 
       
 
         [0045]     Data residing both in the Repository and in the Data Clusters meet with the following standards and regulations.  
         [0046]     EMPI Standard (Enterprise master patient index)  
         [0047]     HL7—Health care messaging protocol  
         [0048]     HIPPA—Permissions regulations for discloser of clinical data  
         [0049]     ICD 9/10—A diagnosis coding convention  
         [0050]     CPT—Clinical Path Ways standards  
         [0051]     In other forms of the invention, different configurations are used.  
         [0052]     Those of skill in the art will recognize that the invention may be embodies in other specific forms without departing from the spirit or essential characteristics thereof. The presently described embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all variations of the invention which are encompassed within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.