WO2006081103A1 - Method and system for managing patient data with analytical instruments in direct communication with each other - Google Patents

Method and system for managing patient data with analytical instruments in direct communication with each other Download PDF

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Publication number
WO2006081103A1
WO2006081103A1 PCT/US2006/001614 US2006001614W WO2006081103A1 WO 2006081103 A1 WO2006081103 A1 WO 2006081103A1 US 2006001614 W US2006001614 W US 2006001614W WO 2006081103 A1 WO2006081103 A1 WO 2006081103A1
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WO
WIPO (PCT)
Prior art keywords
instrument
patient
instruments
data
body fluid
Prior art date
Application number
PCT/US2006/001614
Other languages
French (fr)
Other versions
WO2006081103B1 (en
Inventor
Anwar A. Azer
Ramon E. Benet
Original Assignee
Instrumentation Laboratory Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Instrumentation Laboratory Company filed Critical Instrumentation Laboratory Company
Priority to CA2594343A priority Critical patent/CA2594343C/en
Priority to EP18196655.7A priority patent/EP3457407B1/en
Priority to JP2007553132A priority patent/JP6046323B2/en
Priority to AU2006208341A priority patent/AU2006208341B2/en
Priority to EP06718658A priority patent/EP1842146A1/en
Publication of WO2006081103A1 publication Critical patent/WO2006081103A1/en
Publication of WO2006081103B1 publication Critical patent/WO2006081103B1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/41Detecting, measuring or recording for evaluating the immune or lymphatic systems
    • A61B5/411Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/40ICT specially adapted for the handling or processing of patient-related medical or healthcare data for data related to laboratory analysis, e.g. patient specimen analysis
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0266Operational features for monitoring or limiting apparatus function
    • A61B2560/0271Operational features for monitoring or limiting apparatus function using a remote monitoring unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02Operational features
    • A61B2560/0266Operational features for monitoring or limiting apparatus function
    • A61B2560/0276Determining malfunction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/145Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150847Communication to or from blood sampling device
    • A61B5/150854Communication to or from blood sampling device long distance, e.g. between patient's home and doctor's office

Definitions

  • the invention relates to a method and system for managing patient date. 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.
  • 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
  • the instruments traditionally communicate with the server to access the information.
  • a user located at the server cannot typically analyze a sample.
  • communications may be delayed.
  • server-centric arrangements can result in a chain reaction of inefficiencies such as data unavailability and inefficient medical treatment.
  • the present invention relates to a method, system, and apparatus for managing patient data.
  • the invention relates to a system for managing patient data having many instruments.
  • the instruments have a sampling member for sampling 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.
  • 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.
  • on 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.
  • 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.
  • the invention in another aspect, 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 associate with the body fluid sample.
  • the communications module facilitates instrument-to-instrument communications.
  • the instrument also includes a user interface for receiving user instructions relating to the analytical module, the data management module, and the communications module.
  • the management 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.
  • the performance of competency testing can be determining a pattern of occurrences to facilitate better training.
  • the invention in yet another aspect, 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 ranges of the results of the analysis.
  • the invention in another aspect, 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.
  • 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.
  • 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.
  • 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, Massachusetts), and a VITROS DT60 II Chemistry System (Johnson & Johnson, Piscataway, New Jersey).
  • Other instruments may be, for example, a handheld instrument such as a handheld glucose sensor.
  • the instruments 104 can be located in, for instance, a hospital, a doctor's office.
  • a medical facility a patient'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.
  • one instrument of the system may be located in a hospital, and another one of the instruments may be located in a doctor'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.
  • instrument 104" the description applies to any or all of the instruments 104, 104', 104".
  • 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".
  • 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.
  • a central processing unit CPU
  • 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.
  • 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.
  • 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 mange, direct, and/pr amplify messages over the network 116. Examples of direct 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'.
  • 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 it 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'.
  • 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.
  • the direct communication between the first instrument 104 and second instrument 104' is shown with a first communications channel 144.
  • the direct communication between the first instrument 104 and third instrument 104" is shown with a second communications channel 148.
  • 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., Tl, T3, 56kb, X.25), broadband connections (ISDN, Frame Relay, ATM), and wireless connections (802.11).
  • 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'.
  • the direct communication between the other instruments 104 enable 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').
  • the direct communication between two or more instruments 104 is bidirectional.
  • 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.
  • the direct communication in 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 fo ⁇ nation for the first instrument 104.
  • 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.
  • 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'.
  • the agent-instrument 204 stores the clinical data associate with a sample obtained by a sampling member of one or more of the instruments 104.
  • 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.
  • the instrument 104 stores the patient data obtained from the sample.
  • 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).
  • instruments 104 can communicate with the instrument 104 that sampled the patients' body fluid to obtain data associated with the body fluid.
  • the agent-instrument 204 also transmits the patient data to a hospital information system 208.
  • 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's patients.
  • the agent- instrument 204 may also retrieve information from the hospital information system 208.
  • one 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.
  • 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.
  • 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, Massachusetts).
  • the first instrument 104 controls a second instrument 104' that is manufactured by a different company altogether.
  • the first instrument 104 is a GEM iQM 4000 analyzer and the second instrument 104' is a VITROL DT60 II Chemistry System (Johnson & Johnson, Piscataway, New Jersey).
  • 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.
  • the sampling member 120 of the instrument 104 has an analytical module 304 for analyzing patient data.
  • 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.
  • 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.
  • 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 uses 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 instrument 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.
  • 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++.
  • 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, Washington, NETSCAPE NAVIGATOR, by AOL/TIME WARNER of Sunnyvale, California, and MOZILLA FIREFOX by the MOZILLA FOUNDATION of Mountain View, California.
  • 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's status, enable or disable analytes, enable or disable operation 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.
  • 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').
  • 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.
  • 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's body sample. The data management module 320 can also 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 320 module to search patterns, such as a pattern in a patient'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.
  • 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.
  • the data management module 320 can perform inventory management. For example, if the sampling member 120 employs cartridges to sample a patient'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') need to be replaced. [0036] 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.
  • an instrument 104 e.g., the third instrument 104
  • a user can access the user interface 316 and the data management module 320 for a web browser (e.g., Internet Explorer developed by Microsoft Corporation, Redmond, Washington).
  • a web browser e.g., Internet Explorer developed by Microsoft Corporation, Redmond, Washington
  • a user can use the web browser executing on a personal computer (e.g., in the user's office in the hospital) to access the data management module 320 and/or the user interface 316.
  • 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 interface 316 on the instrument 104 can perform.
  • a remote user can, for instance, view a snapshot of the instrument screen display, review patient or quality control results, review the instrument'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.
  • each instrument 104 comprises a communications module 124 to facilitate inter-instrument communication.
  • the communications module 124 is an eternal component of the instrument 104 that (i.e., an internal wireless network interface card, transponder, or other signal-generating device).
  • the communications module 124 is an external device that, for example, can be periodically connected to the instruments 104 via an interface.
  • 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 analyzes the body fluid sample (step 420) and obtains patient data.
  • the second instrument 104')or any other instrument 104) the accesses, directly from the first instrument 104, the patient data corresponding with the analysis of the sample (step 425).
  • the second instrument 104' instructs the first instrument 104 to sample a body fluid and steps 415, 420, 425 are started.
  • the first instrument 104 samples a body fluid (e.g., blood) from a patient, as shown in step 415.
  • a body fluid e.g., blood
  • 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 associate with the analysis of the sample or may access the patient data after a long time delay (e.g., four days later).
  • 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' the performs the requested analysis (STEP 530).
  • 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 re 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.
  • a medical technician tending to a patient and using a first instrument 104 requests an analysis of a previously drawn sample of the patient.
  • 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 535) back to the first instrument 104 (STEP 540), where the results are displayed.
  • 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).
  • 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.
  • an extracorporeal device such as a blood pump used during a cardio- bypass procedure.
  • 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.

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

METHOD AND SYSTEM FOR MANAGING PATIENT DATA WITH ANALYTICAL INSTRUMENTS IN DIRECT COMMUNICATION WITH EACH OTHER
METHOD AND SYSTEM FOR MANAGING PATIENT DATA
Field of the Invention
5 [0001] The invention relates to a method and system for managing patient date. 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
0 [0002] Medical facilities such as hospitals and doctor'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.
[0003] Typically, such instruments are connected to or communicate with a standalone computer to perform the data management functions relating to the processing 5 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 used interface than the user interface of the instrument. Furthermore, in facilities using different user instruments for different procedures, each instrument 0 may have it 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 difference 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 5 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. [0004] 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 date 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
[0005] 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 body fluid from a patient and directly communicate with each other.
[0006] 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.
[0007] 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, on 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. [0008] 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.
[0009] 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 associate 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 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.
[0010] 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.
[0011] 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 ranges of the results of the analysis.
[0012] 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
[0013] 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.
[0014] 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.
[0015] 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.
[0016] 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.
[0017] 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
[0018] 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, Massachusetts), and a VITROS DT60 II Chemistry System (Johnson & Johnson, Piscataway, New Jersey). Other instruments may be, for example, a handheld instrument such as a handheld glucose sensor. The instruments 104 can be located in, for instance, a hospital, a doctor's office. A medical facility, a patient'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'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".
[0019] 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. [0020] 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 mange, direct, and/pr amplify messages over the network 116. Examples of direct 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'.
[0021] 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 it 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.
[0022] 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. [0023] 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., Tl, T3, 56kb, X.25), broadband connections (ISDN, Frame Relay, ATM), and wireless connections (802.11).
[0024] 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 enable 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 in 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 foπnation for the first instrument 104. Thus, independent of which instrument's sampling member 120 samples a patient'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.
[0025] 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 associate 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 patients' body fluid to obtain data associated with the body fluid.
[0026] 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's patients. The agent- instrument 204 may also retrieve information from the hospital information system 208.
[0027] 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. [0028] 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, Massachusetts). 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 VITROL DT60 II Chemistry System (Johnson & Johnson, Piscataway, New Jersey).
[0029] 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.
[0030] 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, 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'.
[0031] The user interface 316 enables a uses 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 instrument 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, Washington, NETSCAPE NAVIGATOR, by AOL/TIME WARNER of Sunnyvale, California, and MOZILLA FIREFOX by the MOZILLA FOUNDATION of Mountain View, California.
[0032] 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's status, enable or disable analytes, enable or disable operation 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.
[0033] 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's body sample. The data management module 320 can also 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 320 module to search patterns, such as a pattern in a patient'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.
[0034] 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.
[0035] Additionally, the data management module 320 can perform inventory management. For example, if the sampling member 120 employs cartridges to sample a patient'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') need to be replaced. [0036] 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.
[0037] In a particular embodiment, a user can access the user interface 316 and the data management module 320 for a web browser (e.g., Internet Explorer developed by Microsoft Corporation, Redmond, Washington). For instance, a user can use the web browser executing on a personal computer (e.g., in the user'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 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'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.
[0038] 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 eternal 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.
[0039] 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) the 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 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 associate with the analysis of the sample or may access the patient data after a long time delay (e.g., four days later).
[0040] 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' the performs the requested analysis (STEP 530). 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 re 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.
[0041] 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 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).
[0042] 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.
[0043] 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.
[0044] What is claimed is:

Claims

1. A system for managing patient data, the system comprising: a plurality of instruments, each instrument comprising a sampling member for sampling a body fluid from a patient wherein at least one instrument in the plurality of instruments is in direct communication with at least one other instrument.
2 The system of claim 1 wherein the at least one instrument in direct communication with the at least one other instrument accesses patient data acquired by the at least one other instrument.
3. The system of claim 1 wherein the direct communication comprises control of the at least one instrument by the at least one other instrument.
4. The system of claim 3 wherein the control is selected from the group consisting of calibrating the at least one instrument, processing a sample on the at least one instrument, turning the at least one instrument on, and turning the at least one instrument off.
5. The system of claim 3 wherein the control initiates a measurement of an analyte in a patient sample.
6. The system of claim 1 wherein the at least one instrument in the plurality of instruments is in direct communication with at least two other instruments in the plurality of instruments.
7. The system of claim 1 wherein the direct instrument-to-instrument communication comprises bidirectional communication.
8. The system of claim 1 wherein the sampling member further comprises an analytical module for acquiring patient data by analyzing a target component in the body fluid sample.
9. The system of claim 2 wherein the patient data comprises an analyzed target component.
10. The system of claim 2 wherein the accessing patient data is selected from the group consisting of viewing status of the at least one other instrument, viewing operations on the at least one other instrument, and searching patient results on the at least one other instrument.
11. The system of claim 1 wherein the at least one instrument in the plurality of instruments further comprises a single user interface for managing the analysis of the body fluid sample and for managing patient data.
12. The system of claim 11 wherein the user interface displays, in a common format, patient data acquired by the each instrument and patient data accessed by the each instrument that is acquired by the at least one other instrument.
13. The system of claim 11 wherein the single user interface is implemented using a browser application.
14. The system of claim 1 wherein at least on instrument in the plurality of instrument comprises an agent instrument.
15. The system of claim 14 where at least on instrument in the plurality of instruments transmits patient data to the agent instrument after acquiring the patient date.
16. The system of claim 14 wherein at least one instrument in the plurality of instruments transmits patient data to the agent instrument after accessing the patient data.
17. The system of claim 14 wherein at least on instrument in the plurality of instruments accesses patient data from the agent instrument.
18. An instrument for communicating patient data, the instrument comprising:
a) an analytical module for analyzing a body fluid sample;
b) a data management module in communication with the analytical module and the data management of data associated with the body fluid sample; and
c) a communications module in communication with the analytical module and the data management module for facilitating direct communication with other like instruments.
19. The instrument of claim 18 wherein the management of data is selected from the group consisting of generating a report, managing security information, performing competency testing, determining a pattern associated with the instrument, performing inventory management, and determining workload of the instrument.
20. The instrument of claim 18 wherein the security information further comprises login information.
21. The instrument of claim 18 wherein the report further comprises at least one of a quality control report, a regulation report, and a workload report.
22. The instrument of claim 18 wherein the generating of the report further comprises automatically generating the report.
23. The instrument of claim 18 wherein the performing competency testing further comprises determining a pattern of occurrences to facilitate better training.
24. The instrument of claim 18 wherein the data further comprises patient information.
25. The instrument of claim 18 wherein the data further comprises analytical data associated with the analysis of the body fluid sample.
26. The instrument of claim 18 further comprising a user interface for receiving user instructions relating to the analytical module, the data management module, and the communications module.
27. The instrument of claim 26 wherein the user interface comprises a browser application.
28. A method for accessing patient data, the method comprising:
(a) connecting a plurality of instrument to a network, each instrument comprising a sampling member for sampling a body fluid from a patient; (b) sampling, by a sampling member of a first instrument in the plurality of instruments, a body fluid from a patient;
(c) analyzing, by the first instrument, the body fluid sample; and
(d) accessing, by a second instrument directly from the first instrument, the results of the analysis.
29. The method of claim 28 wherein the direct communication in step (a) further comprises controlling at least one instrument by at least another instrument.
30. The method of claim 29 wherein the controlling further comprises calibrating the at least one instrument, processing a sample of the at least one instrument, turning the at least one instrument on, and turning the at least one instrument off.
31. The method of claim 28 where step (d) further comprises at least one of viewing status of the first instrument, viewing operations on the first instrument, searching the patient data on the first instrument, and controlling the first instrument.
32. The method of claim 28 further comprising:
(e) configuring one or more of the plurality of instruments according to predetermined acceptable ranges of the results of the analysis.
33. A system for managing patient information, the system comprising: a plurality of instruments, each instrument comprising a sampling member for sampling a body fluid from a patient; and a plurality of communication modules, a communication module being associated with each of the plurality of instruments, for exchanging patient information with other of the plurality of instruments, whereby the patient information is exchanged directly among the plurality of instruments such that the patient information is permanently stored or processed on an apparatus other than the one or more of the plurality of instruments.
PCT/US2006/001614 2005-01-27 2006-01-17 Method and system for managing patient data with analytical instruments in direct communication with each other WO2006081103A1 (en)

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JP2007553132A JP6046323B2 (en) 2005-01-27 2006-01-17 Method and system for managing patient data using analytical instruments that communicate directly with each other
AU2006208341A AU2006208341B2 (en) 2005-01-27 2006-01-17 Method and system for managing patient data with analytical instruments in direct communication with each other
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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7972280B2 (en) 2005-01-27 2011-07-05 Instrumentation Laboratory Company Method and system for managing patient data
WO2021113238A1 (en) * 2019-12-02 2021-06-10 Gen-Probe Incorporated System and methods for lab automation data sharing

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060009727A1 (en) * 2004-04-08 2006-01-12 Chf Solutions Inc. Method and apparatus for an extracorporeal control of blood glucose
US20090088615A1 (en) * 2007-10-01 2009-04-02 Mark Ries Robinson Indwelling Fiber Optic Probe for Blood Glucose Measurements
US8323194B2 (en) * 2009-12-18 2012-12-04 Inlight Solutions, Inc. Detection of bubbles during hemodynamic monitoring when performing automated measurement of blood constituents
US20100168535A1 (en) * 2006-04-12 2010-07-01 Mark Ries Robinson Methods and apparatuses related to blood analyte measurement system
US20100094114A1 (en) * 2008-10-09 2010-04-15 Mark Ries Robinson Use of multiple calibration solutions with an analyte sensor with use in an automated blood access system
US20090054754A1 (en) * 2007-08-21 2009-02-26 Mcmahon Dave Clinician-controlled semi-automated medication management
US20090156975A1 (en) * 2007-11-30 2009-06-18 Mark Ries Robinson Robust System and Methods for Blood Access
US20090048576A1 (en) * 2007-08-13 2009-02-19 Mark Ries Robinson Managing Cross-contamination in Blood Samples Withdrawn from a Multilumen Catheter
WO2006122741A2 (en) * 2005-05-17 2006-11-23 Roche Diagnostics Gmbh Host apparatus and method providing calibration and reagent information to a measurement apparatus which makes use of a consumable reagent in a measuring process
EP1954190A4 (en) * 2005-11-15 2010-10-13 Luminous Medical Inc Blood analyte determinations
EP2041524A4 (en) * 2006-07-13 2011-11-23 I Stat Corp Medical data acquisition and patient management system and method
JP5809151B2 (en) * 2010-09-16 2015-11-10 パナソニックヘルスケアホールディングス株式会社 Biological sample measurement system
RU2622372C2 (en) 2010-12-22 2017-06-14 Конинклейке Филипс Электроникс Н.В. System and method for caregiver and patient care equipment control
US9665956B2 (en) 2011-05-27 2017-05-30 Abbott Informatics Corporation Graphically based method for displaying information generated by an instrument
US8560251B2 (en) 2011-08-16 2013-10-15 Instrumentation Laboratory Company System and method of increasing sample throughput by estimation of a sensor endpoint
ES2608592T3 (en) 2011-08-16 2017-04-12 Instrumentation Laboratory Company Extrapolation of data from interpolated sensors to increase sample throughput
US9524372B2 (en) 2011-09-09 2016-12-20 Alverix, Inc. In-vitro diagnostic device using external information in conjunction with test results
US9715579B2 (en) * 2011-09-09 2017-07-25 Alverix, Inc. Distributed network of in-vitro diagnostic devices
US9904890B2 (en) 2015-03-13 2018-02-27 Instrumentation Laboratory Company Detecting a transient error in a body fluid sample
WO2016195896A1 (en) * 2015-06-05 2016-12-08 Abbott Point Of Care Inc. Systems and methods for assuring quality compliance of point-of-care instruments used with single-use testing devices
EP3304368B1 (en) * 2015-06-05 2023-06-28 Abbott Point Of Care, Inc. Systems and methods for assuring quality compliance of point-of-care single-use testing devices
US11331040B2 (en) * 2016-01-05 2022-05-17 Logicink Corporation Communication using programmable materials
WO2017222833A1 (en) 2016-06-22 2017-12-28 Becton, Dickinson And Company Modular assay reader device
WO2018144627A1 (en) 2017-01-31 2018-08-09 Logicink Corporation Cumulative biosensor system to detect alcohol
EP3668383A4 (en) 2017-08-17 2021-04-28 Logicink Corporation Sensing of markers for airborne particulate pollution by wearable colorimetry

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0542413A1 (en) * 1991-11-12 1993-05-19 Protocol Systems, Inc. Ambulatory patient monitoring systems
US5904708A (en) * 1998-03-19 1999-05-18 Medtronic, Inc. System and method for deriving relative physiologic signals
EP1304633A1 (en) * 2000-06-02 2003-04-23 ARKRAY, Inc. Measurement device, and measured data transmitting method
EP1338295A1 (en) * 2002-02-26 2003-08-27 Lifescan, Inc. Systems for remotely controlling medication infusion and analyte monitoring
US20040167464A1 (en) * 2002-07-24 2004-08-26 Medtronic Minimed, Inc. Physiological monitoring device for controlling a medication infusion device
WO2006001929A1 (en) * 2004-06-14 2006-01-05 Medtronic Minimed, Inc. System for providing blood glucose measurements to an infusion device

Family Cites Families (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3874850A (en) * 1972-07-24 1975-04-01 Radiometer As Blood analyzing method and apparatus
US3960497A (en) * 1975-08-19 1976-06-01 Beckman Instruments, Inc. Chemical analyzer with automatic calibration
CA1112474A (en) * 1978-09-18 1981-11-17 Guy Belanger Apparatus for the detection and the measurement of hydrogen concentration in a liquid
JPS57196145A (en) 1981-05-28 1982-12-02 Olympus Optical Co Ltd Measurement of ion concentration
EP0074498B1 (en) * 1981-09-04 1985-12-04 F. HOFFMANN-LA ROCHE & CO. Aktiengesellschaft Method and apparatus for the calibration of sensors
US4787398A (en) * 1985-04-08 1988-11-29 Garid, Inc. Glucose medical monitoring system
US4734184A (en) * 1985-08-29 1988-03-29 Diamond Sensor Systems, Inc. Self-activating hydratable solid-state electrode apparatus
JPS62294959A (en) * 1986-06-16 1987-12-22 Toshiba Corp Measurement of ion activity
US4975647A (en) * 1987-06-01 1990-12-04 Nova Biomedical Corporation Controlling machine operation with respect to consumable accessory units
US5061631A (en) * 1988-10-14 1991-10-29 Fisher Scientific Company Method, apparatus and solution for calibration of partial pressure value
US5070023A (en) * 1988-10-14 1991-12-03 Fisher Scientific Company Aqueous ferrioxalate compositions useful as calibrants
DE3844386A1 (en) * 1988-12-30 1990-07-05 Toshiba Kawasaki Kk METHOD AND ARRANGEMENT FOR DETERMINING THE CONCENTRATION OF AN ELECTROLYTE
US5067093A (en) * 1990-01-24 1991-11-19 Eastman Kodak Company Reference reading in an analyzer
US5103179A (en) * 1990-03-05 1992-04-07 Industrial Chemical Measurement, Inc. Water analyzer with multiple electrodes
US5198093A (en) * 1990-05-10 1993-03-30 Orion Research, Inc. pH and concentration meter
JPH04313933A (en) * 1991-04-11 1992-11-05 Nittec Co Ltd Data communication system for automatic analyzer
US6192320B1 (en) * 1991-07-30 2001-02-20 The University Of Virginia Patent Foundation Interactive remote sample analysis system
JPH08275927A (en) 1992-02-13 1996-10-22 Seta:Kk Homestay medical care system and medical device used in this system
US5697366A (en) * 1995-01-27 1997-12-16 Optical Sensors Incorporated In situ calibration system for sensors located in a physiologic line
JP3234751B2 (en) * 1995-07-01 2001-12-04 株式会社堀場製作所 Uncalibration warning method in analyzer
US6136607A (en) * 1995-11-02 2000-10-24 Bayer Corporation Multi-analyte reference solutions with stable pO2 in zero headspace containers
DE19546535C2 (en) 1995-12-13 2000-02-03 Karl Cammann Measuring cartridge for liquid or gaseous samples, process for their operation and their use
US5766432A (en) * 1996-04-17 1998-06-16 University Of Massachusetts Method and device for eliminating electrode drift
DE69807042T2 (en) * 1997-01-17 2003-02-06 Metracor Technologies Inc METHOD FOR CALIBRATING SENSORS IN DIAGNOSTIC TEST METHODS
US6088608A (en) * 1997-10-20 2000-07-11 Alfred E. Mann Foundation Electrochemical sensor and integrity tests therefor
JPH11142411A (en) 1997-11-05 1999-05-28 Hitachi Ltd Clinical inspection system
US6210971B1 (en) * 1999-01-25 2001-04-03 Bayer Corporation Assay for the detection of creatinine
US20030057108A1 (en) 1999-12-10 2003-03-27 Ramamurthi Sridharan Device and method for accelerated hydration of dry chemical sensors
AU1453901A (en) 1999-12-22 2001-07-03 Catharsis Medical Technology, Inc. Adverse drug event monitoring
US6554788B1 (en) * 2000-06-02 2003-04-29 Cobe Cardiovascular, Inc. Hematocrit sampling system
JP4313933B2 (en) 2000-07-11 2009-08-12 日本電気株式会社 Auction information providing system and auction information providing method
US6512986B1 (en) * 2000-12-30 2003-01-28 Lifescan, Inc. Method for automated exception-based quality control compliance for point-of-care devices
JP2002282218A (en) 2001-03-28 2002-10-02 Matsushita Electric Ind Co Ltd Portable examination terminal, examination system, communication terminal and method of examination
JP3966070B2 (en) * 2002-05-10 2007-08-29 松下電器産業株式会社 Device control system and portable terminal
US7258673B2 (en) * 2003-06-06 2007-08-21 Lifescan, Inc Devices, systems and methods for extracting bodily fluid and monitoring an analyte therein
US7289761B2 (en) * 2003-06-23 2007-10-30 Cardiac Pacemakers, Inc. Systems, devices, and methods for selectively preventing data transfer from a medical device
US7972279B2 (en) 2005-01-27 2011-07-05 Instrumentation Laboratory Company Method and system for managing patient data

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0542413A1 (en) * 1991-11-12 1993-05-19 Protocol Systems, Inc. Ambulatory patient monitoring systems
US5904708A (en) * 1998-03-19 1999-05-18 Medtronic, Inc. System and method for deriving relative physiologic signals
EP1304633A1 (en) * 2000-06-02 2003-04-23 ARKRAY, Inc. Measurement device, and measured data transmitting method
EP1338295A1 (en) * 2002-02-26 2003-08-27 Lifescan, Inc. Systems for remotely controlling medication infusion and analyte monitoring
US20040167464A1 (en) * 2002-07-24 2004-08-26 Medtronic Minimed, Inc. Physiological monitoring device for controlling a medication infusion device
WO2006001929A1 (en) * 2004-06-14 2006-01-05 Medtronic Minimed, Inc. System for providing blood glucose measurements to an infusion device

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7972280B2 (en) 2005-01-27 2011-07-05 Instrumentation Laboratory Company Method and system for managing patient data
US8728007B2 (en) 2005-01-27 2014-05-20 Instrumentation Laboratory Company Method and system for managing patient data
WO2021113238A1 (en) * 2019-12-02 2021-06-10 Gen-Probe Incorporated System and methods for lab automation data sharing

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