Patent Publication Number: US-2009227897-A1

Title: Patient identification for point of care diagnostics

Description:
The present invention pertains to point of care diagnostics (POCD) and will be described with particular reference thereto. However, it is to be appreciated that the invention may also find application in other areas which involve the collection and analysis of blood, tissue, or other bodily materials. 
     Currently, blood and other tissue and fluid samples are taken from a patient and placed in an appropriate, usually sealed container. In some instances, the sample is analyzed with automated analysis equipment which is located in the same room as the patient. Once the sample is analyzed, a human operator correlates the test results with the specific patient. In other instances, the attendant marks the containers with an identification of the patient and the containers are sent to a central laboratory for analysis. Often, the containers are marked with a bar code which is read by the analysis equipment such that the test results are automatically correlated with the bar code identification. However, a human operation is still used to correlate a specific patient with the bar code. 
     Although the medical personnel are well-trained, these manual steps still raise the possibility for human error. Because a course of treatment is often predicated on the analysis results, any instances of human error can have dire consequences. 
     The present application is directed to reducing or eliminating the potential for human error. 
     In accordance with one aspect of the present invention, a point of care diagnostics system is provided. A container receives a biological sample from a patient. An analyzer assembly receives the biological container and generates both analysis results of the biological sample and a biometrically based patient indicator. 
     In accordance with another aspect of the present invention, a method of point of care diagnosing is provided. A biological sample is taken of a patient. The sample is analyzed and the analysis results are generated along with a biometrically based patient identification for use in correlating the analysis results with the patient from whom the biological sample was taken. 
     One advantage of the present invention resides in a reduction in the potential for human error. 
     Another advantage of this invention resides in an improved confidence that analytical results are attributed to the proper patient. 
     Yet another advantage of this invention resides in increased assurance that a patient is receiving a proper course of treatment. 
     Still further advantages of the present invention will be appreciated to those of ordinary skill in the art upon reading and understand the following detailed description. 
    
    
     
       The invention may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. 
         FIG. 1  is a diagrammatic illustration of a blood sampling and analysis system in accordance with the present invention; 
         FIG. 2  illustrates an alternate embodiment of a blood sampling system; 
         FIG. 3  is a diagrammatic illustration of an alternate embodiment of an analyzer system; and, 
         FIG. 4  illustrates another embodiment of the present invention. 
     
    
    
     With reference to  FIG. 1 , a body fluid or tissue sampling device  10  includes a container, such as a capillary tube  12 , for receiving the blood or other tissue or fluid samples. The capillary tube includes a needle  14  for puncturing a patient&#39;s finger to get a small sample of blood which is drawn into the capillary tube. The capillary tube further includes a label  16  which carries a unique serial number in a machine-readable format. 
     The needle end  14  of the capillary tube projects through a biometric sensor surface  20 . More specifically to the illustrated embodiment, the sensor surface  20  is a glass or transparent plate  22  below which a fingerprint scanner  24  is mounted. When the patient presses its finger against the glass plate  22  and the capillary needle  14  to draw the blood sample, the scanner reads the patient&#39;s fingerprint. Concurrently, a reader  26  reads the unique identification on the label  16 . A processor  28  receives the fingerprint information from the scanner and the unique serial number from the reader  26  and provides this information to a central hospital patient records memory  30 . 
     In an alternate embodiment, the label reader  26  is replaced with a label printer. The processor  28  communicates biometric information from the scanner  24  to the printer to print the biometric identification as a coded identification of the patient or to the central memory to determine the identity of the patient. A central processor  32  then retrieves the patient identification and communicates it to the sampling processor and printer, which prints the patient identification on the label  16  in a machine-readable format. 
     An automated analysis system  40  receives the container and appropriately positions it with appropriate analysis electronics and other equipment  42  as may be appropriate to perform the requested analysis. The analysis system  40  further includes a reader  44  which reads the label  16 . A processor  46  receives the label information from the reader  44  and the analysis results from the automated analysis equipment  42  and communicates the information to the central hospital memory  30  for storage in the patient&#39;s records. If the label  16  on the container carries a unique serial number, the processor  32  at the central memory correlates the serial number with the serial number communicated from the sampling processor  28  at a sampling station. The central processor  32  or the analyzer processor  42  further correlates the biometric scanner information with a specific patient such that the analysis results are loaded into the proper patient record in the central patient memory  30 . If the label carries an identification of the patient, then the processor loads the analysis results into the file of the patient identified on the label. 
     With reference to  FIG. 2 , a container  12 ′ is connected with a finger receiving structure  50  which carries the sensor surface  20 , in this embodiment, a layer  52  of sticky foil or other material which is permanently deformed to hold a patient&#39;s fingerprint or other biometric when the finger or other body part is pressed against it. In the illustrated embodiment, the container is a capillary tube which is connected with a finger-shaped plastic surface that holds the sticky foil. The sticky foil is arranged relative to a needle end of the capillary tube such that pressing the patient&#39;s finger against the capillary tube needle requires the finger to be pressed against the sticky foil surface. In this manner, taking the blood or other biological sample, results in creating a mechanical record of a patient biometric indicator. Of course, other containers are contemplated, such as urine tubes, fecal matter sample containers, and the like. With a urine tube, for example, the sticky foil is adhered to a side surface of the urine tube. The patient presses their thumbprint into the sticky foil in conjunction with the sample collection. Other alternatives include a sticky foil tag that is attached to the container with a tether, a sticky foil surface on a removable cap or cover, and the like. Other medium which record a machine readable copy of fingerprints are also contemplated. 
     With reference to  FIG. 3 , when the container includes sticky foil or another machine readable means for holding or recording a biometric identification, the analysis system  40 ′ includes the sample analysis electronics and equipment  42 ′ as well as a biometric reader  54 . In the illustrated fingerprint embossing embodiment of  FIG. 2 , the reader  54  includes a scanner which scans the sticky foil to analyze and read the patient&#39;s fingerprint. A processor  46 ′ combines the fingerprint analysis information with the analytical results and forwards them to the central hospital patient memory  30 . 
     With reference to  FIG. 4 , each patient record  60  of the patient records memory  30  includes a patient identification  62  such as an identification number or name. It also includes an electronic representation  64  of biometric information, such as fingerprints. Further, the record includes an electronic representation  66  of DNA information. The DNA information may relate to a diagnosed illness and includes a preselected set of DNA markers. The DNA markers are selected for their ability to differentiate between patients and for their simplicity of determination during automated analysis. Analysis for various conditions often involves measuring 50-100 DNA markers. For breast cancer, typically about 80 markers are analyzed. However, for differentiating among patients, a much smaller number of markers may be adequate. For example, 10-12 markers, if properly chosen, could differentiate a patient from over 99% of the other patients in the hospital. Finally, a patient&#39;s medical record includes a medical history portion  68  which includes not only a history of previously diagnosed medical conditions and treatments, but also a history of test results, diagnostic images, and the like. The analysis system  40 ″ as a part of the sample analyzer  42 ′, includes a DNA analyzer  70 . The DNA analyzer makes various DNA analyses as may be appropriate to the requested analysis. Further, if the DNA analysis does not call for the analysis of the selected DNA markers, the DNA analyzer further performs these preselected analyses. Where appropriate, the DNA analysis may be expedited using polymer chain reaction (PCR) technology. 
     The analysis system generates an analysis results record  72 , which includes identification  74  of the sample analyzed. The identification can include the unique sample serial number read by the reader  44  from the analyzed container, an electronic representation of a fingerprint or other biometric measurement as measured by the scanner  54 , a manually entered identification of the sample or the patient, or the like. The sample record further includes an electronic representation  76  of the analysis of the preselected DNA markers, as well as the other results  78  of the analysis performed. 
     When the analysis record  72  is sent to the central patient records memory  30 , the central processor  32  looks at information previously entered into the patient memory to correlate the sample identification  74  with a patient identification  62 . Once the corresponding patient has been identified, the processor  32  compares the preselected DNA markers  66  of the patient record with the DNA markers  76  of the analysis record. If the DNA markers match, then the analysis results are entered into the patient&#39;s records. If the DNA information does not match, then a warning is sent indicating that samples may have been inadvertently interchanged. Preferably, the central processor  32  further uses the DNA information  76  from the sample record to identify the patient to whom the test results belong. Although a comparison with all patient records can be performed, the search can often be simplified through the use of a priori information. For example, samples with a detected DNA mismatch can be held in a buffer and compared first with each other. As another example, where appropriate, the search may be limited to patients who are currently in the medical facility. Preferably, the central processor  32  generates a report identifying the most probable patient(s) to whom the analysis belongs. Alternately, the patients who have samples in testing can be identified in the patient database and the central processor  32  can look to match the patients with samples being analyzed to the analysis results. Of course, if a patient and test results cannot be paired up to a certainty, new samples are taken and the analysis is repeated. 
     The invention has been described with reference to the preferred embodiments. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the invention be constructed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.