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Industry consortium developing standards for POC device connectivity
Dirk Boecker and Emery J. Stephans
Point-of-care (POC) testing is among the fastest-growing segments of the IVD industry. As of 1998, there were roughly 150,000 CLIA-licensed POC-testing sites in the United States alone, and the worldwide market was estimated to be about $1.7 billion. The U.S. portion of that market was roughly $1 billion and growing at a 12–16% annual rate via the deployment of new tests and the displacement of traditional central-laboratory work.
Advances in miniaturization, microprocessors and electro-optic components have enabled the development of handheld devices that can perform diagnostic tests previously only possible using bench-sized instruments located in a central or STAT laboratory. For standard parameters, POC testing offers an inherent advantage over conventional laboratory testing because it allows the physician to perform a diagnostic test at the patient's bedside and to initiate or adjust the patient's therapy much more quickly.
When integrated with laboratory or hospital information systems, POC testing systems promise easier management of patient test results and QA/QC data, implementation of new care models, and direct support for utilization analysis. POC testing can increase the quality of patient care while decreasing its cost—provided fully integrated data management exists. These benefits are likely to be achieved only when the healthcare facility's entire system is interconnected.
Despite their obvious advantages, such POC tests still face major challenges that have limited the broad acceptance and implementation of POC testing procedures. One of the major challenges lies in the fact that the interconnection of current POC test systems is not standardized. Because of the absence of an interface compatible with hospital or laboratory information systems, problems can arise in the areas of QA/QC requirements, device interface standards, and user interface and operator management. The information model, which contains specifications for both the data structures and the rules that must be followed to keep the data internally consistent, can also be affected.
In 1999, a survey of 510 large U.S. hospitals by Enterprise Analysis Corp. (Stamford, CT) showed that only 15% of POC data are currently transmitted to the laboratory information system (LIS) electronically. Another 18% are entered manually, while 67% never get to the LIS at all. In order to improve these statistics, leading U.S. healthcare organizations are now seeking the following characteristics in their POC data flow and management systems:
- A seamless device interface.
- Bidirectional data flow between device and LIS and CIS.
- An integratable QA/QC process for POC devices.
- A POC information model adaptable to existing and applied information management standards (e.g., Institute of Electrical and Electronics Engineers [IEEE] Medical Information Bus [MIB], American Society for Testing and Materials [ASTM], Health Level 7 computer language protocol [HL7]).
The Connectivity Industry Consortium
To address and overcome the connectivity issue, members of the IVD industry and the users of POC devices have formed a new group, called the POC Connectivity Industry Consortium (CIC), whose purpose is to develop a base-level standard for POC connectivity. The group's official vision statement reads: "The vision of the CIC is to expeditiously develop, pilot, and transfer the foundation for a set of seamless 'plug-and-play' POC communication standards ensuring fulfillment of the critical user requirements of bidirectionality, device connection commonality, commercial software interoperability, security, and QC/regulatory compliance." The CIC intends to provide standards that can be spread and broadly accepted throughout the worldwide POC environment because of their clinical, technical, and economic benefits.
The CIC is not a standards-creating body. Rather, it is an industry-driven consortium chartered to develop standardized implementations of existing standards to meet market needs. The CIC is incorporated as a nonprofit organization, funded solely by membership dues from its commercial members. It is an open, nonprofit, industry-driven consortium comprised of device manufacturers, information system vendors, and healthcare providers.
CIC's efforts are intended to help both POC-system manufacturers, for whom the cost of developing proprietary solutions is prohibitive, as well as healthcare providers who are striving to manage the cost and quality of care and must cope with a multitude of device interfaces. Commercial members promise to implement the standard in their products; healthcare provider members promise to implement it at their institutions. This concerted action among manufacturers and providers will set the stage for industrywide acceptance of future CIC standards.
Manufacturers can still join the consortium. They will have a significant advantage in participating because they will be able to influence creation of the POC connectivity standard both through their technical contributions and by voting on the final work product. They will also be able to adapt their own products to the standard very early in the development process.
CIC's plan is to create standards that enable seamless connectivity among point-of-care diagnostic devices and clinical and hospital information systems. The consortium will concentrate on the development of a basic, commercially implementable standard capable of solving the difficulties inherent in two-way data transport and integration, such as problems with QA/QC requirements, device interface standards, data flow and information model, and user interface and operator management.
At CIC's launch meeting in February 2000, the consortium's senior executives announced an organizational structure, as well as a technical plan and timeline, to be used in developing a standards-based connectivity solution. The CIC wants to develop its standard within a 12- to 15-month period. The consortium will then donate the results for maintenance and further refinement to an established standards-setting organization selected by the consortium membership (e.g., IEEE, ASTM). Where possible, the consortium will use existing standards in developing its solution.
Agilent Laboratories (the central research organization of Agilent Technologies, Palo Alto, CA) has taken the lead in organizing the CIC. At the request of the POC testing division of the American Association for Clinical Chemistry (AACC), Agilent Labs proposed the structure and timeline for the CIC and hosted its first meeting in October 1999.
Requirements for Connectivity
Three groups within the provider domain—clinicians, laboratorians, and clinical administrators—have specific requirements that must be met in order for them to accept and adopt broad POC testing within their organizations. Clinicians need the following:
- Timely access to test results.
- Portable instruments that are easy to use and can seamlessly link to both the LIS and hospital information systems.
- Device operation that fits into the clinical workflow.
- Minimal certification requirements.
- An integratable QA/QC process related to the POC device.
- POC-to-LIS compatibility.
- QA/QC management that is adaptable to general laboratory processes.
- Ease of operator training, certification, and certification tracking, because often the POC operators are trained by laboratorians.
- Ease of integration with admission, discharge, and transfer processes and billing systems.
- Secure transmission and access to results.
- Cost-effective deployment.
- Support for provider profiling and utilization review.
Timetable and Relationship to Other Standards
In its 12- to 15-month effort to produce a set of core connectivity standards for POC devices, the CIC will leverage, where available, existing standards efforts. The IEEE-MIB may be a good example. It is an emerging standard for general device connectivity at the bedside. The CIC is interested in opportunities to leverage MIB standards for POC diagnostic device connectivity. However, IEEE-MIB is only one of the existing standards that are applicable to POC diagnostic device interfacing. Therefore, the CIC will consider defining several device interfaces (or profiles), one of which might be an MIB profile. Also, the scope of the CIC encompasses several other system interfaces in addition to the device interface (e.g., EDI interfaces, QA/QC reporting interfaces) that IEEE-MIB does not address.
To ensure that the results will be commercially viable, the consortium has enlisted leading healthcare provider institutions to assist with requirements, validation, and pilot demonstrations of its standards. At the end of the CIC's timeline, the consortium will transfer the developed implementation standards back to chartered standards organizations such as ASTM or IEEE. To facilitate this transfer, the CIC is already actively soliciting relationships with these existing standards bodies.
The Future of the Consortium
The AACC POC testing division will continue to act in its role of catalyst for the CIC. The division's industrial liaison committee, chaired by Emery J. Stephans, president of Enterprise Analysis Corp. (Stamford, CT), will hold a public progress review on July 25, 2000, from 7:30 to 9:30 a.m. at the San Francisco Marriott during the AACC annual meeting.
Dirk Boecker, MD, PhD, is head of the medical department and principal laboratory scientist at Agilent Technologies (Palo Alto, CA); 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).
CIC's members are among the leaders in POC diagnostic devices, healthcare, and information systems. More than 30 diagnostic device vendors, clinical and hospital information system suppliers, and healthcare providers are members of the consortium:
Agilent Technologies
Medtronic
AVL Scientific Corp.
Mt. Sinai Hospital/Mt. Sinai New York University Health
Avocet Medical Inc.
Profil GmbH
Bayer Diagnostics
Radiometer Medical A/S
Cerner Corp.
Roche Diagnostics
Citation Computer Systems
Shared Medical Systems (SMS)
Cholestech Corp.
Sigma Diagnostics Inc.
FluorRx Inc.
Soft Computer Corp.
Geisinger Medical Labs
STC Technologies
GE Marquette Medical Systems
Sunquest
HemoCue
Telcor
HemoSense
University of California, San Francisco—Stanford
Igen International
Lt. Col. Forrest Kneisel (Department of Defense)
Instrumentation Laboratory
Petrie Rainey, MD (Yale—New Haven)
International Technidyne Corp.
Gerald Kost, MD (University of California, Davis)
i-Stat Corp.
Johns Hopkins Medical Institutions
Kaiser Permanente
LifeScan/Johnson & Johnson
The Mayo Clinic
Medical Automation Systems
Medical Devices Agency
Officers
Suzanne Cross
Director of Business Development
Ortho-Clinical Diagnostics
President
Horst Merkle
Point of Care Marketing and Business Development Manager
AVL Scientific
Vice President
Chris Fetters
Senior Systems Engineer
Medical Automation Systems
Vice President—Secretary
Jeff Perry
Medical Informatics Project Scientist
Agilent Technologies
Vice President—Chief Technology Officer
Ken Levy
International Director,
Integrated Hospital, Point of Care
Roche Diagnostics
Vice President—Treasurer
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