By Nicholas Borgert

Each ACCU-CHEK Inform meter has the capability to log test results from 1,000 patients.

Three years after rolling out the ACCU-CHEK® Inform hospital glucose meter, Roche Diagnostics is introducing a number of enhancements likely to propel the system into even more widespread point-of-care use. Since 2001, Roche has sold more than 33,000 Inform systems, the latest in the company’s well-established ACCU-CHEK brand products. Roche supplies one of every two clinical strips used by US hospitals in diabetes care. Last year, U.S. News & World Report reported that Roche had contracts with seven of the top 10 hospitals in the United States.

The ACCU-CHEK Inform system comprises a handheld glucose meter with integrated bar-code scanner, ACCU-CHEK Comfort Curve test strips, and data-sharing software for linking up to a variety of IT platforms. The meter operates with a 4 µL blood sample.

Mary Catherine Coyle, manager of marketing for hospital glucose meters at Roche Diagnostics, describes the company’s typical customer as a large hospital with about 30 glucose meters for testing patients in all types of settings. On an average day, an Inform Meter is used by 18 different operators and stores about 30 glucose test results. Each meter has the capability to log test results from 1,000 patients and can be used by as many as 4,000 operators. Designed to be intuitive and easy to use, the meter is operated only by certified staff; a lockout feature prevents use by unauthorized individuals.

In February, Roche announced a new feature called other test entry (OTE). OTE enables meter operators to enter information for six common point-of-care tests that have required manual data entry in the past. These include visual urinalysis, rapid streptococcus, rapid drugs-of-abuse testing, pregnancy, fecal occult blood, and gastric occult blood tests.

According to Roche, ACCU-CHEK Inform is the only POC glucose system available that offers entry and automatic transfer (with docking) of manual test information. “In developing the ACCU-CHEK Inform System, we have moved toward a new level of functionality that we expect will increase both workflow and efficiency for the health care professionals who use it,” Coyle says.

Rod Cotton, Roche Diagnostics vice president of sales and marketing for the Diabetes Care Hospital Group, says the OTE feature is in the Roche tradition of improving processes for hospitals and health care professionals. “With the OTE functionality of the ACCU-CHEK Inform system, we are further demonstrating our market leadership and helping our customers attain best-in-class point-of-care practices,” he says.

Because the Inform uses rechargeable batteries, operators routinely return the meter to its base unit which serves as both a recharging station and data communications port. The Inform meter system also assists hospitals in reducing patient identification errors; the meter includes an integrated bar-code scanner for capturing patient ID numbers. Coyle says Roche is planning additional enhancements to ACCU-CHEK Inform this year. These new features will enable Roche/ACCU-CHEK customers to more easily satisfy new regulations, such as the HIPAA ruling on patient confidentiality, the JCAHO recommendation on two patient identifiers, and the CAP regulation on analytical reportable range.

Glucose testing to regulate intravenous insulin therapy is increasingly used to reduce the risk of deep sternal wound infection (DSWI) among diabetics who undergo open-heart surgery. Their glucose levels are monitored as often as once an hour. In socioeconomic terms, DSWI’s costs can be substantial. A decade-long study by a Portland, Ore hospital found that a single DSWI generated an average of $26,400 in additional charges and increased hospital stays an average 16 days.

Intensive insulin therapy was widely discussed during a December 2003 consensus meeting of the American College of Endocrinologists. The meeting found that better control of patient glucose levels can reduce postoperative complications. But additional glucose testing would not be easy for hospitals considering staff shortages and the need for more education to implement a safe, effective protocol.

WellStar Health System uses Inform meters in glucose testing for women, children, and infants.

According to Roche, the Inform Meter can help hospitals deliver accurate glucose test results whether patients are receiving increased levels of oxygen (resulting from cardiac bypass surgery) or experiencing varying hematocrit levels. The reportable range and accuracy of ACCU-CHEK Comfort Curve Test Strips can result in less repeat testing than other strips, reducing costs.

Enhancements to the Inform Meter are designed to limit clinical and identification errors. Included is an enhanced patient list with two patient identifiers displayed for confirmation. Also, increased training required for the Inform will be offset by an interactive training tool Roche is planning to release this summer, Coyle says.

Introduction of the Inform was not without challenges. In August 2002, the system was the subject of an FDA Class II medical device recall after discovery of a potential for biased results due to temperature variation. Roche Diagnostics responded quickly to the issue, completing a field upgrade of 21,000 meters in less than 5 months, Coyle says.

Response to Inform System
Fredrick Kiechle, MD, PhD, a veteran of laboratory operations for almost 25 years, is the author of The Hitchhiker’s Guide to Improving Efficiency in the Clinical Lab published by AACC Press. He is also chairman of the Clinical Pathology Department at Beaumont Hospital in Royal Oak, Mich and medical director of the facility’s reference lab. “We’ve been using Roche point-of-care glucose meters for many years,” Kiechle says. “We’re very impressed with the Inform system.” According to Kiechle more than 3,300 Beaumont nurses are certified in the operation of the Inform system—nearly 40% of the hospital’s total staff of 7,821.

Dave Colard is point-of-care testing coordinator at St Luke’s Hospital, one of nine hospitals that make up the second-largest hospital system in greater Kansas City, Mo. Inform has been a valuable addition to point-of-care testing at the facility, Colard says. More than 1,300 certified operators use the Inform system for daily glucose testing.

Among Inform’s most useful features are its bar-code scanning for patient ID, operator ID, and reagents; user ID lockout; quality control lockout with pass/fail option; accurate results obtained within a wide range of hematocrits and ease of docking and downloading into the hospital’s central information system, according to Colard.

“Through bar-code scanning of the bar-code arm bands on our patients, we have greatly reduced the number of patient identification errors from as high as 12.4% to well under 1%,” Colard says. By April of this year, unidentifiable tests at St Luke’s had been reduced to just 15 per month.

Carol Day is point-of-care testing coordinator for the five-hospital WellStar Health System in suburban Atlanta. Several years ago, WellStar chose to switch from ACCU-CHEK to another glucose meter. The complaints from staff started almost immediately, Day says. “We listen to those who perform the tests and interpret the results, so we went back to the ACCU-CHEK Inform system.”

WellStar’s Inform meters are used only in glucose testing for women, infants, and children. “For us, the Inform is trouble free; the meter works precisely and the data is reliably downloaded. Complaints from our nurses and doctors stopped immediately after the switch back,” Day says.

The nearly 800 certified ACCU-CHEK Inform operators at WellStar perform more than a half-million glucose tests each year. This summer, WellStar will begin using Inform meters to enter fecal occult blood testing data, a task previously done manually. “Our nurses are excited; they can’t wait to stop lugging around those notebooks,” Day says.

Nicholas Borgert is a contributing writer for Clinical Lab Products.