The diversity of point-of-care testing (POCT) locations, devices, and operators makes its management and connectivity challenging. However, the greatest benefit of a POCT result is its rapid turnaround time (TAT). That TAT is not realized if the result is not immediately available to the provider or care team for action. Thus, connectivity is imperative to achieve the true benefit of rapid POCT.
Difference in POCT Device Capabilities
One caveat to POCT connectivity is that different POCT devices have differing interface capabilities. Some can only be unidirectionally interfaced, while others are capable of a bi-directional interface. Others may need to be docked for result download. This disparity among devices makes interfacing a multitude of disparate devices quite challenging.
The Role of Standards
In 2000, the Connectivity Industry Consortium was formed with the goal of developing POCT connectivity standards. These standards evolved into the Clinical and Laboratory Standards Institute (CLSI) POCT1-A2 connectivity standard. The intent of the standard was to work toward a plug-and-play environment for POCT connectivity, where devices are easily interfaced to the LIS, EHR, and HIS.
CLSI POCT1-A2, Point-of-Care Connectivity: Approved Standard—Second Edition was developed for those engaged in the manufacture of point-of-care diagnostic devices, as well as the hardware and software used to connect the devices to various information systems in healthcare facilities. The standard intends to provide the basis for multivendor, seamless interoperability between point-of-care devices, data managers, and clinical results management systems.
The standards opened the door for the development of POCT management systems that can connect multiple devices from various manufacturers, thereby eliminating the need for a computer for each POCT device.
Limitations
We are still a long way out from actual plug and play. One POCT device cannot be swapped for another just because they “follow” the same standard. Furthermore, software vendors can only use the POCT1-A2 standard if the instrument supports it. To explain, POCT1-A2 is a standard, like HL7 and ASTM. As an analogy, the standard is a “language” that an instrument either speaks or does not speak, and the intricacies of the device vendors’ implementation and their add-ons is analogous to the dialect of the language. Some POCT devices or instruments only “speak” POCT1-A2, so the interfaces must be written to those specifications. In summary, interfaces are limited by the device capabilities that the device manufacturers support.
The Standard Is Intentionally Broad
One of the “double-edged swords” involved in using these standards is the “open-endedness” or broadness of the vendor-specific directives. Because the standard leaves much to interpretation, vendors can add their own “topics” for features that are not explicitly described in the standard. Interfaces must then accommodate those features in a non-standard way. For example, the standard has a device ID, vendor ID, and serial ID, and different vendors use these interchangeably for different fields, such as MAC Address, Model Number, and Serial Number.
However, the open-endedness of the standard is what gives the protocol great power and longevity. For example, Accriva Diagnostic’s expansion of the standard for the Hemochron allows the interface to share QC lot numbers, reagent lot numbers, and other beneficial information that is not specifically identified in the protocol. This flexibility allows vendors that are responsible for the interface, such as Orchard Software, to provide a central point of management that otherwise would not be possible.
POCT Brings Unique Interfacing Challenges
It is beneficial to have a standard that addresses the unique scenarios of handling POCT data because the way that these instruments are used requires a different data model than the traditional laboratory. Orchard’s interface team believes that the POCT1-A2 standard is well thought out and documented, and we look forward to its progression throughout upcoming years.
Orchard’s Commitment
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Notes
- Clinical and Laboratory Standards Institute. Point-of-Care Connectivity; Approved Standard—Second Edition. CLSI document POCT1-A2 [ISBN 1-56238-616-6].