New System Speeds Analyses, Improves Patient Care, and Interfaces With Existing HIS/LIS
When treating patients with prediabetic and diabetic conditions, especially those who may be critically ill, caregivers require a clear understanding of patient blood glucose levels and of any trends that may reflect on the efficacy of the treatment being administered.

The LifeScan SureStepFlexx professional blood glucose monitoring system. The inset photo shows the compact handheld meter with a test strip inserted for photometric analysis.

To facilitate this process in any POC setting, LifeScan Inc, a Johnson & Johnson Company, has introduced the SureStepFlexx® professional blood glucose monitoring system. Easy to learn and easy to use, this CLIA-waived system consists of three main components:

•Portable, lightweight SureStepFlexx photometric devices. POC professionals—physicians, nurses, phlebotomists, and other technicians—can easily carry these meters on their rounds in compact totes and employ them to perform immediate on-meter analysis of blood samples collected on test strips and to improve care at the patient bedside.

•Disposable, absorbent, reagent-treated SureStepPro test strips. Provided in sealed vials of 25, these strips condition each blood sample (collected off-meter) for analysis and convey the sample into the meter’s optical system. A plastic holder in the meter retains the test strip and is removable to facilitate cleaning or replacement if needed.

•DataLink® Data Management System. This is a three-part, open-architecture, information system that enables POC testing coordinators to program the meters, and analyze and manage test results (with DataLink Control); to download test results (with DataLink Connect); and to transmit data to the hospital or laboratory information system (HIS/LIS) (with DataLink Interface).

A Crucial Blue Dot
The key to understanding the way in which the first two parts of the SureStepFlexx system work involves a “blue dot” on the test strip.

To make the blue dot appear, the user first applies the blood sample to an absorbent pink pad on one surface of the test strip. If the sample is of the correct volume, it reacts with the proprietary reagent impregnated in the strip and causes a uniform blue dot to appear within a few seconds on the opposite surface of the strip. “The amount of blood needed for the test is quite small; only 5 to 30 microliters (mL),” says Diane Snoey, MT (ASCP), marketing manager for Institutional Business at LifeScan. “And because the sample is absorbed and fully contained by the test strip, patients and caregivers need not worry about contamination or cleanup.”

The blue dot visually confirms that the blood sample is of sufficient volume to obtain a valid reading. “An important point to make here is that the required blood may come from any of a wide variety of sources, such as capillary samples from finger sticks, venous blood puncture sites, arterial line draws, blood collection tubes (assuming no fluorides are present), and neonatal blood tests. This adds immensely to the flexibility and user-friendly attributes of the system,” says Snoey.

Once the blue confirmation dot appears, the user inserts the test strip into the SureStepFlexx meter. “The meter uses a patented, optical-reflectance, photometric technology to measure the color intensity of the blue dot,” Snoey explains. “Intensity varies in direct proportion to the patient’s blood glucose level at the moment the blood sample was taken. Then, within 20 to 30 seconds, the measured blood glucose value reads out quantitatively on the meter’s LCD screen.” The measurement range extends from 0 to 500 milligrams per deciliter (mg/dL). “Test results correlate very closely with central laboratory blood glucose assays,” Snoey says. “The correlation coefficient is 0.981–0.987, and precision data show a coefficient of variation of 3.4% to less than 5.0%.”

Off-Meter Collection Reduces Possibility of Transmitting Infections
Because the test strips allow POC professionals to collect blood samples off-meter, the meter itself never comes into contact with the patient. According to Snoey, this significantly reduces the likelihood of transmitting blood-borne pathogens patient-to-patient or patient-to-staff. “Consequently, the SureStepFlexx system represents an excellent diagnostic tool for use in intensive care, neonatal, and isolation units,” she says.

Ease of Customization Accommodates Unique Institutional Requirements
Although the meters and workstations are preprogrammed with commonly used default settings that enable usage immediately upon installation, LifeScan has designed the SureStepFlexx system to be readily customizable by end users to suit any institution’s policies and procedures.

The primary means for customizing the meters is the data management system, which consists of three integrated computer hardware/software subsystems:

DataLink Connect enables bidirectional downloading and uploading of meter information and test results via the institution’s existing Ethernet-based local area network (LAN) or telephone modem connections to a DataLink Control workstation.

DataLink Control enables manipulation, management, and analysis of meter information and test results, and monitoring for regulatory compliance.

DataLink Interface enables seamless transfer of test results to the HIS/LIS, thus enabling consolidation into patient records and facilitating patient and insurance company billing calculations.

According to Paul Hausman, marketing manager of informatics for LifeScan Institutional Business, data may be transferred in the institution’s choice of formats: electronic data interface (which formats results into a defined HL7 unsolicited-results message) or scripted interfaces (which emulate human operators interacting with the host system). “The freedom to select data formats is part of our vision of informatics, which is to enhance the ability of health care institutions to translate raw data into usable information and knowledge and to facilitate appropriate action to improve workflow, compliance, and patient care,” Hausman says.

“POC testing coordinators can easily configure multiple SureStepFlexx meters by means of a single DataLink Control workstation, which connects easily to the meters by means of a convenient cradle,” Hausman says. “The system is flexible enough so that coordinators have the option of assigning different meters to various hospital units, each of which might have different policies and procedures for interpreting the significance of blood glucose measurements for their respective patient populations.”

When a meter is turned on, a unit tag appears on the initial screen that will say, for example, “9 West” or “ER”, and the user will know that this meter should reside in that particular location. And, depending on the location, the POC coordinator will program the meter using limits defined for that specific critical care unit.

“POC coordinators can easily program the meters to set institution-specific and department-specific ‘flags,’” Snoey says. If the meter detects that critical blood glucose levels exceed certain maximums or minimums, these flags can invoke “next-action” instructions (such as adjustments to insulin infusions) and/or display other pertinent information (such as instructions to notify the attending physician).

Intuitive Operation Eases POC Workload
Menus displayed on each SureStepFlexx meter’s touch screen and on the POC coordinator’s workstation screen are intuitive and self-prompting. “This arrangement greatly simplifies training and helps all parties learn more quickly—typically in about 15 minutes—how to employ the various components of the system,” Snoey says. “It also helps ensure that test procedures are performed promptly and reported correctly.”

Snoey notes, “When a meter is turned on, it automatically runs a QC self-check to ensure that the optics are operating properly. If it fails, it locks out the user from proceeding with the test. If it passes, it prompts the user to enter the test strip and checks to make sure that the strip is inserted properly and that the sample is acceptable. If it passes this check, the meter automatically measures the blood glucose level and displays the resulting value. Everything the caregiver needs to know about the patient to make proactive blood glucose management decisions is available on that meter.” The user then simply accepts the results, follows any displayed instructions as appropriate, goes to the next patient, and repeats the process.

Onboard software automatically captures and correctly associates all data about each test strip with the patient, date, time, and user to ensure that all appropriate regulatory requirements are met. Later, when the test results on the meter are downloaded to the POC coordinator’s workstation, the DataLink Data Management System performs another QC check on the data itself, identifying any pertinent discrepancies or trends that may be germane to the proper management of the patient’s blood glucose level. The memory of each meter has a capacity of up to 4,000 different user IDs and can store up to 1,500 test results. This means that institutions can enable any POC professional on staff anywhere, onsite or offsite, to use any meter to perform accurate blood glucose measurements on as many patients as necessary.

The meters are very compact to facilitate such widespread use. Powered by three replaceable AA 1.5-V alkaline batteries, each palm-sized meter measures only 6.34 inches (16.10 cm) high x 3.55 inches (9.02 cm) wide x 1.63 inches (4.14 cm) deep, and weighs only 12.5 ouncses with optional bar code scanner and 12.1 ounces without.

Optional Bar Code Scanner Speeds Data Entry
Particularly advantageous from a customizability standpoint, the meters may be equipped with a bar code scanner to alleviate medical errors associated with manual data recording. “Institutions have the choice of obtaining meters with the bar code scanners already installed, or they may prefer to field-retrofit the scanners at a later date by simply opening the meter battery compartment and snapping the unit into place,” Snoey says.

Complementary Initiative on TGC
LifeScan has recently articulated an educational initiative to help medical institutions realize both the clinical and economic benefits of Tight Glycemic Control (TGC) in the intensive care unit (ICU). This is a useful complement to the SureStepFlexx and other blood glucose management products available from LifeScan. According to company literature, “TGC describes the management and supply of adequate amounts of insulin to maintain glucose levels within a tight range for critically ill patients in the ICU.” Adoption of this approach, says the company, can “reduce the length of ICU stays, reduce mortality rates by 57%, cut bloodstream infections by 46%, and reduce ventilatory rates by 57%.”

Availability and Price Factors
The SureStepFlexx professional blood glucose monitoring system from LifeScan Inc is typically provided as a turnkey solution, which includes all hardware and software, installation, integration with the institution’s existing LAN and HIS/LIS, user training, 24 x 7 x 365 hotline support, and ongoing technical support services. Pricing varies according to the particular institution’s requirements and the overall system configuration. Systems may be purchased outright or leased if capital investment limitations preclude a purchase. Also offered from LifeScan is the LINC pricing tool, which simplifies cost-reporting reimbursement calculations by helping institutions separate operating costs from capital expenditures.

For more information, contact LifeScan Inc, a Johnson & Johnson Company, 1000 Gibraltar Drive, Milpitas, Calif. 95035-6312; (408) 263-9789; fax: (408) 946-6070; Web: www.LifeScan.com.

Gary Wolfe is a contributing writer for Clinical Lab Products.