By Gary Tufel
Abbott Laboratories’ MediSense Products has introduced an enhanced version of its handheld, point-of-care blood glucose testing system that features electronic test result data transfer and test strips that prevent usage past the expiration date. MediSense Products Marketing Manager Peter Karkantis says that while two other manufacturers make similar systems, which also utilize test strips, Abbott’s new Precision PCx 2.2.1 system and test strip provides some unique features.
Test strips are bar coded to ensure they cannot be used past their expiration dates.
Bar coding ensures that the strips cannot be used past their expiration dates. The handheld testing scanner reads the bar code and displays a message if the strip has aged past its date, thus avoiding false readings. The system also docks with hospitals’ computer systems to transmit test results electronically. Doctors and nurses can then enter their passwords into any hospital computer, including patients’ bedside computers, to view the results.
The Precision PCx™ point-of-care system was developed based on feedback from diabetes caregivers in hospitals. Featuring an easy-to-use ergodynamic design, the Precision PCx is engineered to provide quick, accurate results while offering powerful data management and security features. It needs just 3.5 µL of whole blood to provide accurate results within 20 seconds, and is designed with features that ensure the accuracy and integrity of test data. These include a field trigger electrode, which emits an audible signal that tells the operator that an adequate sample has been provided. Karkantis adds that the PCx features three of these electrodes; other manufacturers provide two. With the PCx system, the test will not begin until blood covers the third electrode, ensuring that there is enough blood for a valid test.
Other PCx features include automatic initiation of the test procedure once a sample has been detected; and the laser bar code that allows for entry of data, such as patient ID, operator ID, and test-strip information, eliminating manual-entry errors. Patient results are displayed on an easy-to-read, back-lit LCD screen. Results for up to 4,000 patient tests and 1,000 control tests can be stored in the monitor and easily retrieved for review.
The PCx is an element of a Web-based interface, meaning users do not need a dedicated computer to access the system.
The Precision PCx monitor’s data port and an optional docking station can be used to automatically upload these results, via MediSense’s Precision Net™, to the QC Manager™ Point-of-Care Data Management System and then to the laboratory information system (LIS) and/or the hospital information system (HIS). The data port can also be used to establish bidirectional communication between Precision meters and laboratory and nursing PCs. These data management capabilities can help a hospital realize faster data availability, better quality control, increased compliance with CLIA and CAP regulations, improved staff and patient management, and more effective billing.
Precision PCx test strips use MediSense’s advanced biosensor technology to provide glucose results from 20 to 600 mg/dL across a 20% to 70% hematocrit range. Each Precision PCx test strip package features a bar-code label that holds the calibration information about the test strip, including the lot number, the expiration date, and expected control solution ranges.
Karkantis says that the system’s speed is important for several reasons. “Research says that when glucose levels are controlled, patients can be weaned faster from hospitals’ critical areas and moved into the general population faster. Patients heal faster and better, and hospitals save money,” he says.
Another innovation is that the PCx’s software allows the instrument to be more sophisticated on battery maintenance, Karkantis adds. The instrument, which runs on two AA batteries, alerts users far in advance when the battery is low.
Karkantis says that nurses find the PCx ergonomic, easy to hold, and easy to use with one hand. “The other two systems on the market require two hands to use,” he says.
However, the main benefit of the system is in patient safety, he says. “We need to follow hospital guidelines that are now asking for bar-code solutions. We believe that bar coding ensures that patients receive the best and most effective care,” he says.
Susan Utley, point-of-care testing program supervisor for Duke University Hospital and Duke University Medical Center in Durham, NC, agrees. “Individually wrapped strips are a definite benefit, because it assures us the strips have not been contaminated by humidity or other environmental influences. If operators have strips stored in a vial, and the vial is opened frequently, or the lid is not closed as it should be, the strips could be compromised without the operator or the POCT staff knowing. Individually wrapped strips have decreased the need to check loosely capped containers and other storage issues.” Utley is confident the strips remain uncompromised.
“Validation of the lot number in use is also a challenge when strips are stored loose in a vial. Lot numbers may easily be combined without the operator knowing. This can compromise glucose results and patient care,” she adds. “Abbott’s bar coding of each individual strip allows us a sense of security that the operator is using a validated lot number associated with the patient result. This also eliminates dependence on the operator to validate the lot number being used for the glucose test.”
Utley says another significant element of the PCx is its interface and docking system, which allows the meter to transfer the glucose test data electronically into the hospital’s system. The interface process has been complete for 3 years. Utley says Abbott’s interface connectivity allows completion of the process without the cost of extra wiring for connectivity. This could have been quite a challenge when you have 160 glucose meters in use and approximately 133 docking stations, Utley says. In 2003, the Duke University Hospital/Medical Center transferred more than 370,000 patient results. With Abbott’s PCx interface, virtually all of those results were electronically entered into the hospital system.
“Our nurses like the ease of using the PCx. With one hand the operator can scan or enter operator ID, the strip lot, and patient armband information,” Utley says.
An important security feature of the PCx meter is that only those who are trained in its use are permitted to operate it; without training and the proper identification, a user can be locked out from testing.
But the PCx’s greatest utility can be found in the system the data is entered into, Utley says. The latest upgrade of the interface system, 3.0, was installed at Duke last fall, and it is hard to overstate the importance of the new system. “The difference is that it is Web-based. This means I do not need a dedicated computer to access the system. The POCT staff have limitless access into the system at the same time, and from any location within the hospital intranet, allowing them to perform the functions needed. I monitor the system frequently from home, using a secured access, and I can easily check for any alarms, update operator competency, monitor individual meters, or perform any number of functions,” she says.
Utley has given the diabetes manager limited access to the system as well, so she can view a single patient’s records or pull reports on overall glucose data.
In addition, the system allows the performance of operators to be monitored, and provides detailed quality improvement reports on all aspects of the facility’s glucose testing. Summary reports show an easy overview of the performance of individual areas. Monthly location reports allow the nurse managers data, by operator, so they can address staff with their performance. “With previous systems, it would take about a week and a half to pull a seven-page report per meter; now, we get a one-page report for each location in about 5 minutes,” Utley says.
Gary Tufel is a contributing writer for Clinical Lab Products.
