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COMMENTARY
Developing open standards for point-of-care connectivity
Emery J. Stephans
IVD testing at the point of care has come of age, and is now the fastest growing segment of the IVD industry. Handheld blood glucose meters are ubiquitous in hospitals. Point-of-care (POC) chemistry instruments for measuring blood gas, electrolytes, and coagulation parameters are commonplace in critical care units, emergency departments, and general medical wards. The ability of such instruments to provide physicians and nurses with critical data in only a few minutes has helped to improve care in hospitals, and increasingly in clinics, physician offices, and mobile healthcare settings.
Figure 1. Actual and projected revenues for major testing types in the IVD market, through 2008. Source: Enterprise Analysis Corp.
Small wonder that industry projections for spending on POC testing are rosy. Estimates by the Enterprise Analysis Corp. (EAC; Stamford, CT) indicate that the worldwide share of IVD testing performed outside central laboratories will grow from 25% in 1998 to 45% by 2008. Projected annual growth rates of approximately 12% are considered realistic. At that rate, spending on testing outside central laboratories will nearly double from $4.9 billion in 1998 to $7.9 billion in 2008 (see Figure 1). Hospital POC testing alone is projected to increase from $1 billion in 1998 to $3.2 billion in the same period.
The Problem of Connectivity
That said, POC testing is not without its problems. So long as paper patient records prevailed, the data provided by POC instruments could be simply recorded by hand. As healthcare providers began to shift to electronic patient records and hospital accrediting agencies tightened their rules for quality control, manual transcription of results became obsolete. The ability to incorporate POC data into the hospital's data management scheme suddenly took on great importance. In other words, connectivity and the ability to integrate POC data after transmission, have become mandatory.
It is hardly surprising that the manufacturers of POC devices were not ready for such a demand. Under substantial pressure from healthcare providers, and with a certain degree of desperation, major manufacturers developed a variety of solutions for connectivity, quality control, and data integration. In the absence of any industry standards, these solutions were, of course, proprietary. Smaller manufacturers with limited R&D budgets and staff were even less able to provide the connectivity their customers needed, and generally fell behind in attempting to comply with the demands of the marketplace. The result has been the creation of a patchwork of different and incompatible connectivity schemes.
Because hospitals required POC products from many manufacturers—each of which had a different connectivity solution (or none at all)—they have been hit equally hard. For such institutions, managing the emergence of POC testing has presented a variety of challenges: physicians are demanding more POC testing, and accrediting agencies are demanding tighter controls on POC quality and operator certification, all while POC device manufacturers are less and less able to provide the connectivity and data management tools needed to manage the growing POC testing business.
Preliminary data from an EAC survey of 400 U.S. hospitals with 200 or more beds indicate that only 15% of results from hospital POC instruments are transmitted digitally to a laboratory information system (LIS). The results from another 15% of the instruments are entered into the LIS manually. Data from the remaining 70% are not transferred at all.
Searching for Solutions
In 1998, the POC testing division of the American Association for Clinical Chemistry (AACC) determined that connectivity was the most important problem facing its members. The division expressed interest in serving as a catalyst to help industry develop a solution to this problem. The division's industrial liaison committee subsequently organized two open meetings of device users and manufacturers involved in POC testing.
The first meeting, held in conjunction with AACC's 1998 annual convention, confirmed that the lack of standards for connectivity and data management was the most significant problem affecting POC testing. The second meeting, held during AACC's recent 1999 annual convention, reviewed a proposal to create an industry consortium on POC connectivity.
Between the two meetings, the industrial liaison committee undertook wide-ranging efforts to work out the best option. After extensive discussions, the committee determined that the approach with the best chance of success would be to follow the model of the Andover Working Group, a member-funded consortium that has been successful in establishing hospital software interoperability standards. Because this group is administered by Hewlett-Packard (Palo Alto, CA), the committee invited Dirk Boecker, principal scientist and head of the medical department at Hewlett-Packard Laboratories, to present the proposal for a POC connectivity consortium. The proposed industry consortium would be open to any POC sector participant, and would be charged with developing open, industrywide POC connectivity standards.
Invitations for the 1999 meeting were sent to hospitals, POC instrument vendors, LIS companies, regulatory and standards organizations, and members of AACC's POC testing division. Meeting announcements were mailed to AACC's members and posted on the organization's Web sites. These efforts were successful in attracting more than 120 attendees to the meeting.
At the meeting, representatives of leading healthcare institutions expressed their views on the necessity for POC testing standards, the problems encountered due to lack of standardization, and the types of standards they require. Their presentations revealed that the potential benefits of POC testing to healthcare organizations and industry will be realized only if standards are developed to enable POC test results to be easily integrated into the information systems of user institutions. Defining the benefits of industrywide connectivity standards was straightforward:
- Healthcare providers would be able to mix and match instruments from several manufacturers and integrate test results with ease, saving labor and avoiding transcription errors.
- Manufacturers would be assured that products developed in compliance with the standards would be accepted by a broad user base.
- The POC sector could look forward to continued energetic growth. Without common standards, EAC estimates that the projected 12% growth rate would be cut in half—a significant impact on a sector that is just beginning to mature.
- The impact of POC testing on medical and cost outcomes would be easier to determine (without connectivity, no data would be available for use as the basis of outcomes measurements).
he meeting concluded with a survey to determine attendees' level of interest in supporting the standardization effort. On the basis of 86 completed surveys, more than 80% of attendees concurred with the proposed plan and volunteered the active participation of their organizations.
Conclusion
All in all, the 1999 meeting brought the POC industry together as never before. Together, the attendees acted to endorse an aggressive course of action to resolve the problem of POC connectivity standards.
Based on this endorsement, Hewlett-Packard has set October 20, 1999, as the date of a workshop in Palo Alto, CA, that will serve as the kickoff for the new POC connectivity consortium. POC test manufacturers and users, and companies in the healthcare information technology sector, are invited to attend this meeting and participate in the work of the open industry consortium.
Emery J. Stephans is president of Enterprise Analysis Corp. (Stamford, CT) and chair of the industrial liaison committee for the point-of-care testing division of the American Association for Clinical Chemistry (Washington, DC).
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