by Louise Lazear

POC connectivity driven by customers
The use of point-of-care laboratory instruments has grown largely due to the drive to improve patient care: faster results mean faster treatment decisions, particularly in critical care situations. Innovations in instrument technology have propelled the market as well, creating the acceptance of and need for testing at the point of care in a variety of settings. According to some estimates, the portion of IVD testing performed outside of the central lab will grow to 45 percent by the year 2008 worldwide. But with this opportunity comes challenge: how to control and maintain the quality of central lab testing at remote sites and meet regulatory requirements, and how to incorporate results into the patient record. Faced with a myriad of instruments with proprietary communications standards and the expense of designing multiple interfaces to existing LIS and HIS systems, POC device users spearheaded the push to POC connectivity.

According to a 1999 survey of 510 hospitals conducted by Enterprise Analysis Corporation (EAC), satisfaction scores for data management and connectivity were the lowest of all categories polled, including accuracy and ease of use of POC devices. Incorporation of POC testing into the LIS and HIS has become a front-burner issue.

New standards
Recognizing the need for and value of POC connectivity, the AACC’s POC Testing Division sought to define the problem and bring together stakeholders to develop a solution. In 1998, the division’s Industrial Liaison Committee called an open meeting of POC manufacturers, LIS companies, and POC users, eventually culminating in the formation of the Connectivity Industry Consortium (CIC) in February 2000. Composed of a group of vendors including Roche Diagnostics, Radiometer, i-STAT and Instrumentation Laboratories, as well as healthcare providers and professional organizations, the CIC was charged with developing open industry-wide connectivity standards for POC devices following protocols successfully utilized in the development of hospital software integration standards.

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     In a remarkable effort, the CIC finalized the standards and placed them under the under the purview of NCCLS, a standards development organization with extensive expertise in issues regarding the clinical laboratory. In December 2001, NCCLS released the approved standard as document POCT1-A, providing the framework for design of POC devices, workstations and interfaces to communicate bidirectionally with LIS and other systems in a vendor-neutral environment.

     “The goal of the standard is to make every POC device ‘plug and play’,” said James Nichols, Ph.D., medical director of clinical chemistry at Baystate Health System (BHS), and founding member of the AACC POC Division. “From a consumer’s standpoint, one would like to have all (POC) device results integrated into the central laboratory information system and into the HIS. The problem is that many of these devices were developed for outpatient settings, and then were found to have applications in the hospital. And in finding those applications, they became subject to CLIA, which developed into a drive to collect the total cycle of data required to meet regulatory guidelines,” he said. According to Nichols, the NCCLS standards will allow hospitals to streamline current POC operations as well permit easier integration of new or additional POC devices, including those vendors pursuing web-based and wireless connectivity. Additionally, connectivity serves to capture billing as well consistency in documentation, which is important in monitoring trends in patient care liability protection. “Although regulatory issues drove the need for connectivity, billing capture is an added advantage that justifies the expense. Much of POC testing is performed for acute management of inpatients, and many of these tests are reimbursed as part of a DRG, a flat fee for a single patient admission. Despite the lower potential for recovery, it is important from a resource management aspect to monitor what tests are being done, and how many.”

     Currently, BHS utilizes three computer systems with separate interfaces to the LIS to manage data from blood gas, glucose and coagulation devices located throughout the facility. In order to streamline integration of new POC technology, BHS instituted both a POC committee for budgeted items, as well as a technology and therapeutic committee to review new capital equipment expenditures. Requests for new technology are submitted on standardized forms, which according to Nichols helps clinicians to focus on their needs, staff, resources and of course, budget.

Expanding the market
A key question for new technology stakeholders is whether the vendor is, or will be compliant with NCCLS connectivity standards.” The standards provide information to the laboratory and hospital on how messaging occurs,” said Jeffrey DuBois, Ph.D., vice president of business development at Nova Biomedical, and chair holder of the POCT1-A standards committee at NCCLS. “Technically, there is a lower-level messaging standard, IEEE 1073, which is the communication standard for a POC device to a data manager. Then there is an upper-level HL7 messaging standard for communication between the data manager and a clinical information system (LIS/HIS). These protocols standardize how devices, data managers, and clinical information systems communicate with each other bidirectionally. The IT people in the hospital need this information to identify a defined HL7 structure and format that they can track and implement,” he said.

     Understanding the plight of POC information management is not new to DuBois, who feels that hospitals must customize connectivity according to their needs. While clinical laboratory director at University Hospitals of Cleveland (UHC), he experienced the challenge of trying to capture approximately 350,000 POC glucose tests per year. During his tenure there, DuBois implemented a remote access and order entry system using Nova’s Patient Data Manager, a system that provides access to data and supervision of multiple analyzers remotely placed throughout the medical center. DuBois feels that with NCCLS standards in place, the POC market is poised to expand. “Main drivers in the POC market are convenience and immediacy of data. Connectivity will help the acceptance of new products, and make their integration more seamless.”

Vendor solutions
Despite their recent publication, many POC data management and IVD vendors have begun to work toward NCCLS standards. Both Medical Automation Systems (MAS) and Telcor, Inc. offer vendor-neutral POC testing data management systems that interface directly with some existing POC platforms. For example, the MAS RALS-Plus is a scalable, modular system that offers results capture, QC management and interface to LIS. Several IVD vendors, including Lifescan, ITC, Roche Diagnostic and Instrumentation Laboratories have established relationships with MAS as a connectivity solution for their clients. For management of glucose monitoring, MAS offers the RALS-G, or RALS-Plus for Glucose to electronically link devices to a central monitoring station. Telcor, Inc. offers the Quick-Suite family of products, which offer scalable vendor-neutral solutions for POC connectivity.

     With the development of NCCLS standards, the ability to offer vendor-neutral POC connectivity has spurred interest among IVD manufacturers to enter into the information management arena. For some, connectivity is not a new concept. “We introduced our Central Data Station (CDS) in 1992 with a scripted interface to the LIS to provide centralized control of POC testing,” said Michael Groves, Ph.D., vice president of international sales and operations at i-STAT. “Back then, we had to sell the overall idea of remote testing under laboratory control. Today, hospitals expect and demand connectivity from a vendor.” According to Groves, over 1,000 Central Data Stations have been implemented in the U.S. to date. Using this system, data from multiple i-STAT handheld analyzers are sent to a CDS using downloaders located throughout the health care institution. The downloaders, communicating on a network or serial basis, send the infrared data from the hand helds to the CDS, which is typically located in the laboratory. Data are monitored by a POC coordinator, and generally include patient demographics, user information and results. Communication is bi-directional, and through the CDS, the coordinator may monitor users, check QC status, send software to the hand helds, and customize the handheld user interface.

     Groves sees connectivity as providing value to the hospital by capturing results into the patient record, which improves reimbursement and provides caregivers accessibility to lab data from anywhere within the information system. IVD manufacturers benefit as well. “From the vendor’s perspective, communication is a two-way street. It gives us access to non-confidential information that allows us to understand how the product is really being used.” According to Groves, i-STAT supports open data management systems, and is already developing interfaces that will be vendor neutral. “A goal of i-STAT is to see its products fit into every hospital data management structure,” he added.

     Instrumentation Laboratory offers the IMPACT for Critical Care, a proprietary connectivity solution for use with IL devices. While the IMPACT currently supports an ASTM communications protocol. IL is moving all of their connectivity solutions to be compliant with CIC specifications. IL is also exploring web-based communications, and offers remote control of the GEM Premier 3000 by the IMPACT via a web-based link. Links to IMPACT from other IL analyzers via the web are under development. As all vendors move toward NCCLS standardization, IL is developing the IMPACT to provide a single-source solution for POC connectivity. “Today we are seeing an irreversible trend toward decentralized testing, not only in the U.S., but elsewhere. For example, in Germany about 80 percent of lab testing is done in decentralized locations,” said Sam Cowan, product manager for critical care at IL. “Connectivity is being driven by the need to be more efficient, and the ability to control these POC devices.”

     Radiometer Medical A/S has developed Radiance, a software-based STAT analyzer management system installable on an existing hospital server, or on a PC-based server that can also function as a workstation. “Our system is modular and is designed to meet customer needs, “ said Heidi Egensperger, Radiance product manager. “We spend time determining those needs up front, so much of a customer’s specific configuration is completed before going on site, reducing installation time.” The company works closely with a hospital’s IT department, and with the laboratory and respiratory departments on the requested reports and applications of the software. User input into future product development is also welcomed. And, while maintaining high quality results in near patient testing remains the primary goal of POC connectivity, the company recognizes that hospitals look to economics as well. According to Egensperger, “Managing POC information is an investment, as opposed to just a cost. Recovery of previously uncaptured, unbilled tests helps offset the cost of a data management system, in addition to the productivity enhancements it brings. If vendors can continue to provide high-quality POC testing in a cost-efficient manner, then hospitals and respiratory departments will continue to look at decentralized testing as a good investment in improving patient care.”

     Roche Diagnostics offers a flexible platform for both glucose and multi-device, multi-analyte POC data transfer and device management. The DataCareGM, designed specifically for glucose monitor connectivity, can be integrated into the DataCarePOC, which manages data from multiple devices in multiple locations. Both systems are scalable, providing on-site upgradeability without the need to alter the customer interface software. Data from remote devices is collected and sent to a central station, usually located in close proximity to the POC coordinator. Bidirectional flow of information allows control of most remote devices from the central station. According to Chris Bosler, marketing director for hospital POC at Roche, the system has been successfully linked to over 70 different devices. Bosler noted that while POC data management requires the involvement of many groups within the hospital, all are working toward a common goal. “It’s a fairly complex decision making process,” said Bosler. “However, I feel that connectivity has been the key factor in improving the quality of POC testing.”

     The advent of POC connectivity brings value to hospitals, laboratorians, clinicians and to vendors as they develop new data management products to support their technology. And as POC devices become more “plug and play,” many feel that applications for remote laboratory testing will continue to grow. With connectivity, laboratories can monitor and maintain the quality of their product throughout the healthcare continuum. So perhaps the biggest benefactors are patients, as all stakeholders work to the common goal of improving patient care.

Louise Lazear is a freelance writer in Charlotte, N.C.