American Association for Clinical Chemistry
Better health through laboratory medicine
July 2007 Clinical Laboratory News: The Challenges of Point-of-Care Connectivity

 
July 2007: Volume 33, Number 7

The Challenges of Point-of-Care Connectivity
How A New Tool Can Aid Labs with Device and Data System Purchasing
By Deborah Levenson

Point-of-care testing (POCT) devices with the ability to link to each other and lab information systems (LISs)—known as connectivity—can help reduce medical errors, improve staff compliance with regulatory requirements, boost revenue from testing, and track wasted supplies. In most labs, POCT connectivity has come a long way from the 1990s, when many POCT devices lacked essentials such as ports that allowed them to transfer results to a lab data management system or ports with keypads for data entry. In those early days, a few manufacturers offered instruments that allowed labs to move data from the device to a patient’s chart, but each had its own suite of products, necessitating multiple computers to handle data. Today, while issues with POCT connectivity are not as troublesome, labs often fall short of the ultimate goal of using such devices: fast, complete transfer of accurate information.

“Connectivity means no manual transcription in order to move test data into the LIS. Labs need point-of-care devices that capture all of the necessary information accurately and effectively,” emphasized Patrick St. Louis, PhD, Laboratory Director at MDS Pharma Services Central Lab in Mississague, Ontario and Chair of a Clinical and Laboratory Standards Institute (CLSI) (Wayne, Pa.) subcommittee that developed a recently released guideline intended to help lab and other hospital staff purchase products that enable proper connectivity.

In many labs, the menu of tests changes quickly, but devices’ and information systems’ ability to ‘talk’ have not kept pace, noted David Colard, MT, a member of the CLSI committee that developed the guide. He recently left his job as Point-of-Care Coordinator at St. Luke’s Hospital in Kansas City, Mo. and is now an Applications Support Analyst at St. Luke’s Health System in Lee Summit, Mo. “The menu of tests changes quickly. If data management systems and devices aren’t standardized, there’s a big time lag in getting information into the system.” And as laboratorians know, “if the result doesn’t get into the electronic medical record quickly, a physician can’t act on it,” Colard noted.

CLSI’s new guideline, known as POCT2-P, is intended to help POCT users from all healthcare backgrounds influence the purchase of POCT devices, LISs, and LIS upgrades. It explains what features are necessary and desirable and can help labs ask device and information technology vendors the right questions in order to buy equipment that’s well suited to their individual facilities.

Explaining Connectivity in Simple Language

CLSI’s new POCT2-P document actually summarizes a standard written for information technology professionals and software engineers. Known as POCT1, this technical standard issued in 2001 is a complicated engineering protocol developed by representatives of more than 60 manufacturers that was intended to remedy a “haphazard” situation for lab data management, according to James H. Nichols, PhD, a member of the CLSI committee that developed the guide and Associate Professor of Pathology at Tufts University School of Medicine and Director of Clinical Chemistry at Baystate Health, Springfield, Mass. While some manufacturers offered connectivity, each product suite had its own database, computer system, and cabling. Because companies developed products individually, devices and lab information systems had no common language, “handshake,” or cabling. “It was costly for hospitals to implement a new data management system because you needed a bench full of computers, none of which could talk to each other.” Nichols recalled. “This situation was slowing down care.”

In response, the Industrial Liaison Committee of AACC’s Critical and Point-of-Care Testing Division formed the Connectivity Industry Consortium (CIC) in 1999, which included representatives from 60 manufacturers of POCT devices and LISs, plus laboratorian experts in POC testing. After CIC developed POCT1 in 2001, the National Committee for Clinical Laboratory Standards in (Wayne, Pa.)—now known as CLSI—took charge of the document. Although the release of POCT1 was a major achievement and marked a milestone for POCT, many laboratorians had trouble using it. “POCT1 is one of the longest, most complicated documents in CLSI history,” noted Chris Fetters, District Sales Manager at Nova Biomedical, Waltham, Mass., member of the CLSI committee that developed the recently released guideline to POCT1, and a stockholder in Medical Automation Systems (Charlottesville, VA), which markets point-of-care information management products. “Anyone who wasn’t an engineer looked at it and said, ‘We don’t understand this.’ ”

In response, CLSI developed the POCT2-P guideline for laboratorians, clinicians, and other healthcare staff responsible for point-of-care testing or reliant on it. According to Nichols, although POCT1 was first issued in 2001, it and the recent guide are both timely because vendors are just now beginning to market unique databases that meet POCT requirements. “New POCT products take five to ten years to develop, so we’re now entering the adoption phase for POCT1,” he explained. Among the available POCT1-compliant database products are the RALS data management system from Medical Automation Systems, and the Quick-Link System from Telcor in Lincoln, Neb. Both systems can connect with products from multiple vendors, Nichols noted. Other POCT1-compliant data management products include the Aegis POC from Laboratory Data Systems (Lithia, Fla.).

A few POCT1-compliant devices are currently available. These include glucose meters from HemoCue (Angelhom, Sweden) and Fetter’s company, Radiometer Medical’s (Westlake, Ohio) Radiance Stat analyzer management system, and Roche Diagnostics’ (Indianapolis, Ind.) CoaguCheck XS Plus system. Biosite (San Diego, Calif.) expects that the next generation of its Triage(R) MeterPro device will comply with POCT1, according to Nadine Padilla, Vice President for Corporate & Investor Relations. ITC (Piscataway, N.J.) intends all of its future POCT devices to be POCT compliant, according to Paul Savuto, Director of Marketing, who added that an updated, POCT-1 compliant version of its HEMOCRON Signature Elite POC coagulation device will be available this month. The company is now developing a combined platform POCT device, he added.

Later this year, CLSI will issue POCT3-P, a guideline to POCT1 for manufacturers, Nichols noted. The goal of the forthcoming CLSI guideline is to explain POCT1 in a way that directly addresses manufacturers’ needs and concerns so that companies can better provide standardized products to labs.


Who Needs POCT2-P

While the guideline is intended primarily as a tool for talking to salespeople, it can also help laboratorians deal with clinicians, who also have a vested interest in purchases. “Some clinicians will come to the lab wanting to do a specific test faster, and they’ll have their heart set on a particular instrument. This guide will help the lab decide whether to buy it. It also will help explain why you need a compliant instrument, and serves as a primer on connectivity, wireless devices, and other things to come,” Fetters explained.

While responsibility for making purchase decisions about instrumentation and LIS often falls squarely on lab shoulders, this isn’t the case in all institutions, Colard added. In some hospitals, sales representatives focus mainly on clinicians, who aren’t generally aware of all of labs’ needs. “Physicians are interested in quick results for their clinical processes. Physicians don’t think about quality control issues and related regulations that don’t pertain to them,” Colard pointed out. “This document tells clinicians what’s useful and necessary to those who manage the lab and the POC coordinator.”

Must-Have Features

At the heart of the guideline is a list of 10 primary requirements that Nichols termed “must-haves” for all POCT devices and LISs. Chief among them is bidirectional connectivity so that POC devices can communicate seamlessly with databases, and vice versa. Moreover, the database manager should be able to communicate with devices, the guideline points out. It also stresses the need for “plug-and-play” capability that comes from standardized device connections that allow devices to connect to any database, LIS, and hospital information system (HIS) so all devices use common docks, ports, and wiring for communications. “If you can plug and play, with everything standard, you have lower costs because there is less need to tinker with the data management system. The whole reason for the standard initially was to lower connectivity costs,” Colard explained.

The CLSI guideline emphasizes that devices, at a minimum, must have some way that the lab can meet the requirements of regulatory bodies like the Joint Commission, College of American Pathologists, as well as CLIA regulations. For example, the Joint Commission has a patient safety goal that requires two forms of identification from patients prior to drawing blood in order to ensure that they are getting the right tests. “Unless you have bidirectional connectivity, that’s impossible,” Fetters explained.

Colard pointed out that simple capabilities, like quality control (QC) lockout, go a long way toward helping labs comply with CLIA. The federal law requires two levels of quality control within any 24-hour period for glucose meters—the most common POCT device—and within 8 hours for devices that measure blood gases. Lockout features can be set to force QC within required timelines, and so devices don’t work if the quality control test fails, he explained.

Other features that laboratorians should demand include the ability to use commonly existing infrastructures to eliminate the need to install new hardware along with standard services like telephone and Internet access, the capability to conserve existing hardware and IP addresses, and support of common ordering situations and the typical LIS order generation processes, so that orders and results are linked. Also necessary, according to the guideline, is compatibility with available software from both POCT device manufacturers and LIS, HIS, and other database vendors. Operation of any POCT device must be intuitive and functionally free of simple problems that impede the goal of giving timely test results, the guideline notes. “You’ve got to make it as simple and user-friendly as possible. And without any standard, it’s a Wild West out there,” Fetters commented.

Security Issues

The guideline’s emphasis that devices must ensure confidentiality of sensitive patient data and inclusion of an appendix section devoted to security issues drew praise from Jay Jones, PhD, Director of Chemistry and Regional Laboratories at Geisinger Health Systems, Danville, Pa. Jones oversees labs for a healthcare system considered by many to be one of the most “wired” in the nation (See Sidebar, below). He pointed out that the guideline will also ease discussions with hospital information technology departments, as well as device and LIS vendors. “IT will have a whole slew of questions that will hit most laboratorians right in the face. There will be numerous network access and security issues that laboratorians will need to get up to speed with,” Jones said.

Geisinger Health System Offers a Glimpse of the Future

At Geisinger Health Systems in Danville, Pa., early adoption of information technology and focus on connectivity within the lab and throughout the system has yielded 10 years’ worth of data that the system is now mining to develop best practices. In April, Geisinger opened a $23 million Outcomes Institute that is using data from LDL cholesterol, HbA1c, and microalbumin tests to develop best practices for treating cardiovascular disease and diabetes, according to Jay Jones, PhD, Director of Chemistry and Regional Laboratories. “With the data, we’re able to show that we’re ordering the right tests and using the right procedures to treat diabetes and heart disease,” he explained.

The institute was made possible in part by an unusual relationship between the lab and the information technology (IT) departments. “We got our feet wet early, working shoulder to shoulder with the ‘techies.’ As a result, we were early adopters of connectivity back in 1991 and had the first HL7- interface connected POC devices in 1998,” Jones recalled, explaining that HL7 is an International Standards Organization protocol. After bringing automation into labs in the 1990s, Geisinger did not lay off its lab technologists. Instead, the system moved the technologists into IT jobs. “We saw that lab support in the IT realm would be crucial in the future. We were assertive that IT people who actually run applications still work in the lab, even through the computers are located in a data center on campus.” Today, those same staffers help with interfaces for automated lab instruments and “can speak both ‘lab-ese’ and ‘IT-ese,’ Jones noted, adding that the vast majority of IT system analysts and other staff who maintain the routine operations of the lab information systems are past lab technologists, including the lab information system director.

Noting the growing threat posed by computer viruses and other malicious code, the guideline emphasizes that data security should be an overall focus for healthcare organizations rather than an issue to be considered on a per-device or per-system basis. “A system is only as secure as its weakest link; thus, data security is a systems and solutions issue, not a particular technology issue,” the guideline states. Its appendix explains the procedure for identifying hazards and urges healthcare professionals to consider data’s authenticity, a device’s vulnerability to attacks and malicious manipulation, and protection against unauthorized access.

Should-Haves

The guideline also lists secondary requirements that Nichols described as “connectivity objectives that were important, but not must-have objectives.” These include a configurable user model that allows POCT devices to be used in many different places and situations, so that they can be carried to a bedside, or put on portable carts, mobile helicopters, or other vehicles. A related “should have” is instrument-dock integration involving a station for POCT devices so that they can communicate directly with the database without any need for intervening steps like a laptop or file conversion.

Another desirable characteristic is the ability to force a download. The connectivity system needs to support POCT device lockout when the device doesn’t communicate with the data manager within a client-defined time period. Such a lockout feature should include a simple mechanism for overriding download lockout in the event of a catastrophic loss of connectivity, according to the guideline.

The ability to qualify results through notes entered into devices and data systems would be very useful in a variety of clinical maintenance, and quality control situations, the guideline points out. “It is important to be able to annotate some results,” the guideline notes, adding that this capability would be useful in the event of fingersticks, with error codes, or when critical-action limits are exceeded.

The guideline also suggests that devices have the capability to accept manual entry of data, including that from noninstrumented testing, allowing remote access capability to the data manager from the central lab or offsite, via the Internet, and the ability to block or deselect test results and test options from being transferred to the data manager or medical records. Finally, the connectivity system should permit data mining and manipulation or data export in usable forms, according to the guideline.

It also presents a list of future characteristics that Nichols describes as a wish list of features that do not exist in data systems today “but are very important to think about.” These include wireless communication “that is totally automatic and does not require operator interaction.” While no manufacturer has yet gone totally wireless, Nichols expects the first such instruments to become available within 1 to 2 years, and predicts “at least fifteen years until they are ubiquitous in hospitals.”

Incentives for Manufacturers

While standardization of LIS and devices lowers connectivity costs for labs and hospitals, in theory it would also lower manufacturers’ costs associated with developing new data systems and devices. “But there’s probably no incentive for the LIS and data management companies to ever completely comply with the standard. If everything is completely plug and play, then companies don’t need to be involved, and then how will they get their revenue?” Colard pointed out.

That’s a problem that CIC considered when getting financial support from manufacturers to develop POCT1, noted Emery Stephans, a member of CIC and President of Enterprise Analysis in Stamford, Conn., an independent consulting company which counts many of the major lab device manufacturers as clients. “We knew when the standard was written that companies wouldn’t be motivated to support something that would force them to give up revenue. So the customers, hospitals, had to force changes by saying, ‘we will only buy compliant devices’. We told LIS and data management companies that changes would increase test volume and revenue for everyone in the long term.” Early supporters, like Sunquest Information Services, which was bought by Misys Healthcare Systems (Raleigh, N.C.), had the foresight to see that a short-term sacrifice would yield economic benefit later, Stephans explained.

Noting that the debate over whether manufacturers will adopt the connectivity standard still simmers, Stephans commented, “You may notice that it’s no longer necessary to have four computers in your office to support POCT.”