Originally Published IVD Technology September 2001
POC connectivity standard approaches the finish line
Last year, the Connectivity Industry Consortium (CIC), an IVD industry group comprising device manufacturers, information system vendors, and healthcare providers, set out to establish standards that create a universal way to integrate point-of-care (POC) data with laboratory information systems. Now, a year later, the CIC has managed to accomplish that goal, and new connectivity standards are on their way to being formally accepted and published.
The need for such standards was made apparent largely through integration problems that were being encountered by end-users. During the past decade, advances in microfluidic and other miniaturization technologies have led to the creation of POC diagnostic devices that have enabled physicians to perform diagnostic tests at a patient's bedside. However, each POC vendor had its own unique way of connecting its devices with an institution's information system, forcing these institutions to deal with multi-POC device integration and thereby increasing their equipment and management costs.
Initially, the CIC took on the challenge of putting together standards that would meet healthcare providers' needs for uniform connectivity and data transfer in POC devices. At the same time, though, the consortium wanted to create standards that would be open enough for manufacturers to produce competitive advantages on top of the baseline. In addition, the CIC wanted the standards to be flexible enough to meet the needs of international providers and vendors.
As a result, the CIC's technical teams produced a three-part connectivity proposal and completed the final review and ballot of these proposals at the beginning of May 2001. After the proposals were ratified, the CIC transferred them to three chartered standards development organizations (SDOs) for publication and future development. These SDOs—the National Committee for Clinical Laboratory Standards (NCCLS; Wayne, PA), Health Level 7 (HL7; Ann Arbor, MI), and the Institute of Electrical and Electronics Engineers (IEEE; New York City)—have committed to producing an approval-level connectivity standard for publication.
NCCLS has primary publication responsibility for the entire set of POC connectivity standards. After receiving the CIC draft standards last May, NCCLS formed a POC subcommittee within its area committee on automation. Both the subcommittee and the area committee reviewed the draft CIC standards. Once both of those committees approved the draft, NCCLS distributed it to its members and other interested parties for a 60-day review period. Comments submitted during that review period were addressed by the subcommittee.
During the annual meeting of the American Association for Clinical Chemistry (AACC), held last month in Chicago, NCCLS officials announced that the POC subcommittee had approved the CIC proposal as a draft-level standard. Also during the AACC meeting, the NCCLS area committee voted to advance the draft to the status of a candidate standard and distribute it to NCCLS delegates for a 60-day voting period, which is the final voting stage before action is taken by the NCCLS board of directors. The next steps will be review and approval by the board of directors and publication of the CIC standards as an NCCLS standard. NCCLS officials expect that both steps will be completed before the end of this year.
NCCLS officials have been impressed with the CIC standards and believe that the standards, once approved, will have a beneficial impact on the industry.
"Manufacturers that have been involved with this proj-ect are very excited about its expected use to ensure connectivity of POC instruments," says John Zlockie, assistant executive director for standards at NCCLS. "The expectation is that with one uniform standard published through NCCLS and developed through the CIC process, its intended purpose will come about. This standard will provide a more coherent, uniform approach to solutions for integration problems."
HL7 and IEEE committees will have development responsibility for significant sections of the CIC proposals. The HL7 laboratory, automated, and point-of-care testing special interest group will have principle responsibility for the section of the CIC's proposal governing communication between POC data managers and laboratory information systems. The IEEE 1073.3 subcommittee will assume responsibility for the lower-layer POC device interface protocols.—Richard Park
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