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 Point of Care Testing Toolkit

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Point of Care Testing Toolkit
 
  • Introduction & Definitions
  • Advantages & Disadvantages
  • History
  • Current & Projected Technology
  • References
  • Tools
  • Toolkit Authors
  •  
  • Pathologist Roles
  • Pathologist as Laboratory Director
  • Pathologist as Clinical Consultant
  • Pathologist’s Regulatory Role
  • Pathologist as Technical Consultant
  • Give us your feedback on this sectionPathologist as Technical Consultant:
    Patient test results: POCT connectivity
    and data management

    1. POCT data management encompasses the electronic capture of test results within a POCT device and transfer of those results to other computer systems, databases, or electronic medical records.
    2. POCT connectivity specifically refers to the electronic transfer of results from POCT devices to an intermediary database/computer system (the data manager) that allows for data analysis and review prior to transfer of results to a permanent electronic patient record in the laboratory information system (LIS), clinical information system (CIS) or other electronic medical record (EMR).
      1. These results can include QC, PT, patient tests or other types of results (calibration, etc.)
    3. Connectivity can be used to:
      1. Transfer patient results to a medical record, usually an EMR
      2. Allow coordinators or those supervising POCT to remotely monitor and troubleshoot device performance
      3. Improve regulatory compliance through lockouts for QC and operator ID. These lockouts require successful QC analysis at defined time periods. If QC is not performed or fails expected target ranges, the device locks and prevents patient testing. If an operator ID is not recognized in a list of trained operator IDs, the device will also lock and prevent patient testing.
      4. Track user skills through control process error codes during testing and link those to training/competency records. Those records are linked to operator ID in the POCT computerized database and the POCT data manager, a computer server that links and organizes all POCT results, device, and operator records in one database for centralized review and management. POCT coordinators or site administrators can use those records to track operator performance.
    4. POC data management links POC test results with the other information required to ensure compliance with regulatory requirements for test documentation.
      1. This information is automatically captured during testing by the computerized device, so operators do not have to manually document test records.
      2. POCT data management improves regulatory compliance, and guarantees a complete record of all tests performed, something that cannot be ensured with manual documentation.
    5. The data elements linked in a POCT database include:
      1. Test result (patient, quality control, proficiency testing and all other types of results)
      2. Date
      3. Time
      4. Patient identification
      5. Operator identification
      6. Device serial number
      7. Reagent lot numbers (and expiration dates)
      8. QC lot numbers (and expiration dates)
      9. Comments and remarks added by the device during testing
      10. Device flags and error codes associated with the test result
      11. Other data (specific to the device, (e.g., if the patient identification was entered by scanning a barcode) or manual key entry)
    6. Device and system requirements:
      1. In order to collect and manage POCT data, devices must have a minimum set of common features.
        1. The device should have a keypad and electronic display for data entry and selection of test options.
        2. The device also needs storage capacity to maintain records between downloads or transfer of data to a central database (the data manager) if there is not real time wireless transfer of data.
      2. The hospital needs an infrastructure to support the connection of POCT “docking” stations and transfer of data that may consist of serial telephone lines, intranet/internet wiring and ports, or wireless connectivity.
      3. Finally, the hospital will need a computer server to collect data from multiple devices and sites into one data base for review, to manage patient and control test results, to maintain records of operator training, and for configurations of site information to setup devices and reagent lots for use in patient testing.
    7. POCT devices with data management capabilities offer a number of features that can help hospitals maintain records and meet the regulatory demands of documentation. Some of these features include:
        1. Operator lockout – device stores a list of trained operator identifications and will only allow test analysis with a valid identification. Operator identification that does not match the valid ID list will prevent further device operation until a valid ID is entered.
        2. QC lockout – device can be configured to require multiple levels of quality control to be analyzed in a specified time frame. If the minimum number of QC samples is not analyzed or control results do not match expected control ranges, the device will prevent further operation until a successful control of the defined concentration level is analyzed.
        3. Positive patient identification – device maintains a list of active patients through a link with admission/discharge/transfer (ADT) data. Upon entry of a patient identification (either manually or by scanning a barcode), the device can display the patient’s full name and require operator confirmation of name and/or birth date or second patient identifier. This feature helps confirm that a POCT result can be linked to the correct patient and EMR.
    8. Historically, manufacturers developed connectivity options for their own devices in a proprietary manner.
      1. Different manufacturers offer unique data managers for handling data from their specific devices, but systems from different manufacturers would not communicate with each other or share data.
      2. The use of proprietary data management systems required POCT consumers to purchase and manage multiple data manager servers/computers (one for each manufacturer of POCT devices in use).
        1. Staff had to learn different reports, software and computer systems to manage data from glucose compared to blood gas and even coagulation testing. Maintaining different data managers for each test was labor intensive, expensive and inefficient.
    9. Fortunately, CLSI has developed POCT Connectivity Standards that foster the interconnection of POCT devices from multiple vendor data management systems into one data manager system or “middleware” conduit.
      1. These standards are a win-win solution for both consumers and manufacturers by saving the consumer costs in hardware investment and hospital IT infrastructure renovation while saving the manufacturer costs in development and support of separate IT solutions for their products.
      2. However, currently many POCT vendors have yet to convert to the standards, or fully adopt the standards to allow free interchange with their devices, including transfer of results and setup/configuration of devices through any data manager system. POCT users may need to force acceptance with the new connectivity standards by only using devices and vendors who allow an “open system” approach to connectivity.
      3. When faced with losing sales, POCT vendors will probably migrate to the new standards.
        1. If a POCT vendor will not participate in an open system configuration, the POCT site has the option of negotiating with other willing vendors. POCT sites investigating data management and connectivity options should also require very specific responses from vendors about the capabilities of their connectivity systems.
    10. There are currently several vendors of POCT data management systems in the US market that allow interconnection of POCT devices from multiple vendors.
      1. Some of these vendors are capable of bidirectional communication that allows transfer of test results from the device while simultaneously uploading reagent lots, new operators, and configurations of device settings. Other vendors require that the POC device connects through the device manufacturer’s proprietary data manager before sending data to a central POCT data manager and also don’t openly connect to all POCT systems.
      2. The current POCT data manager vendors include:
        1. Laboratory Data Systems - Aegis POC Manager
        2. Medical Automation Systems – RALS
        3. Telcor – Quick-Linc
        4. CONWORX - POCcelerator
    11. Benefits of POCT data management and connectivity systems
      1. Automates the documentation and transfer of POCT results (QC, PT, and patient results).
      2. Ensures results are automatically recorded. Manual results require staff labor, extra work steps, and therefore all results may not be recorded. With data management, staff can’t perform a test without an electronic record of the result within the device.
      3. Saves staff time over manual documentation
        1. Automates timing and interpretation of test
        2. Detects common operator errors (too little/too much sample application, bubbles, clots, unsuccessful controls, etc.)
        3. Ensures billing compliance through automated EMR result reporting and billing.
      4. Quality is improved by forcing the operator to perform the test in a defined sequence of events (i.e. operator ID entry, reagent lot entry, patient ID entry, sample application, test comments)
      5. Improves test quality and compliance with regulatory requirements through operator and QC lockout features, as well as permanent logs of all results performed.
      6. Wireless connectivity promises real-time data transmission and connectivity eliminating concerns over delays in transmitting results to the patient’s EMR.
    12. Limitations of POCT data management and connectivity systems:
      1. Less than 50% of POCT devices have electronic data capabilities. Most POCT is still visually interpreted, colorimetric dipsticks, cards, or kits without data management capabilities.
      2. Dipstick readers and automated POCT devices with data management capabilities are more expensive than the visually interpreted POCT alternatives. Electronic dipstick readers do not prohibit the staff from continuing to visually interpret dipsticks and bypass the data management features of the readers.
      3. POCT connectivity may require additional computer hardware and facilities renovation (wiring, downloaders, and IP addresses) along with IT infrastructure maintenance in order to adopt a system.
        1. Wireless connectivity is not universal or standardized, therefore, many devices use “docking” stations. However, these require manually placing the device in a station for electronic transmission of results. Intermittent or delayed docking of POCT devices can delay the recording of results to the patient’s medical record for hours or longer and may create confusion in the recorded time of testing or tracking of patient results. Docking stations also require plug in power or batteries. If the station is not plugged in or batteries are not functioning, results will not be transmitted.
        2. POCT vendors still support proprietary data management systems that prohibit connection of devices from other manufacturers and may limit the selection of POCT devices.
    13. Handling POCT results:
      1. POCT tests may have different methodologies with unique interferences and possibly different reference ranges.
      2. Their results should be separately listed in laboratory reports from results of central laboratory methods.
      3. Electronic display of POCT results in the patient’s EMR can be confusing and lead to misinterpretation when POCT results are over-layed with central lab results and results of other methods (i.e. glucose meter vs. central lab glucose vs. blood gas analyzer glucose).
      4. It can be challenging to construct unified laboratory records that reflect central laboratory and POCT results that do not always correspond to each other.
      5. Regulations also require that test result reports be linked to their method or instrument and site of performance.
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