Standard Document
Second Edition
Point-of-Care Testing

CLSI POCT01

Point-of-Care Connectivity

CLSI POCT01 offers engineers the framework to effectively design devices, work stations, and interfaces that allow multiple types and brands of point-of-care devices to communicate bidirectionally with access points, data managers, and laboratory information systems from a variety of vendors.

This document is exclusively available in an electronic format for your convenience and accessibility.

July 28, 2006
Louis J. Dunka, Jr., PhD

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Abstract

Clinical and Laboratory Standards Institute document POCT01-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. This document incorporates the work product of the Connectivity Industry Consortium, an organization that developed specifications for point-of-care device and information system communication interoperability. It provides the basis for multivendor, seamless interoperability between point-of-care devices, data managers, and clinical results management systems.

Scope
This standard establishes a set of specifications to allow seamless multivendor interoperability and communication between point-of-care devices, data concentrators, and clinical information systems. CLSI document POCT01 provides the framework for engineers to design devices, workstations, and interfaces that allow multiple types and brands of point-of-care devices to communicate bidirectionally with access points, data concentrators, and laboratory information systems from a variety of vendors. As an interface standard, this document specifies the common communication interfaces and protocols between systems and devices. It facilitates the transfer of data to support the creation of point-of-care applications, services, and institutional policies. This document does not directly address specific point-of-care application and service level functions, such as device lockout and operator list management. This document specifies protocol, not policy. The interfaces specified support the communication required for engineers to build such application-level functionality. Specifying, building, and providing the applications to support these services are left to customers, device and information system vendors. The only relationship of this point-of-care standard to the laboratory automation domain is through the use of the HL7 standard. In version 2.4, the HL7 standard was expanded to provide elements essential to laboratory automation, which also improved the HL7 standard for the entire laboratory-testing domain. These additions to HL7, along with four proposed new HL7 message triggers (see Section 4.1 in Appendix C of this CLSI standard), enable the point-of-care community to use HL7 as its electronic data interchange (EDI). This specification also leverages several communication standards. It specifies the use of a single device transport protocol (IrDA TinyTP) running over two possible physical layers: IrDA-infrared, as specified by the Infrared Data Association (IrDA) and ISO/IEEE 11073-303002; and cable-connected, as specified by the IEEE 1073 lower-layers standard. This specification also utilizes local area networking standards such as IEEE 802.3 and protocols such as TCP/IP in cases where network connectivity is required.
Product Details
POCT01A2E
1-56238-616-6
308
Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

A CLSI-IFCC joint project.

Authors
Lou Dunka, PhD
Bryan Allen
Todd Cooper
Christopher Fetters
Wayne Mullins
James Nichols, PhD
Thomas Norgall
Paul Schluter, PhD
Robert Uleski
Supporting Resources
CLSI POCT01QG
CLSI Vendor Code Registry, 1st Edition
Companion
Point-of-Care Testing
Free
Abstract

Clinical and Laboratory Standards Institute document POCT01-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. This document incorporates the work product of the Connectivity Industry Consortium, an organization that developed specifications for point-of-care device and information system communication interoperability. It provides the basis for multivendor, seamless interoperability between point-of-care devices, data managers, and clinical results management systems.

Scope
This standard establishes a set of specifications to allow seamless multivendor interoperability and communication between point-of-care devices, data concentrators, and clinical information systems. CLSI document POCT01 provides the framework for engineers to design devices, workstations, and interfaces that allow multiple types and brands of point-of-care devices to communicate bidirectionally with access points, data concentrators, and laboratory information systems from a variety of vendors. As an interface standard, this document specifies the common communication interfaces and protocols between systems and devices. It facilitates the transfer of data to support the creation of point-of-care applications, services, and institutional policies. This document does not directly address specific point-of-care application and service level functions, such as device lockout and operator list management. This document specifies protocol, not policy. The interfaces specified support the communication required for engineers to build such application-level functionality. Specifying, building, and providing the applications to support these services are left to customers, device and information system vendors. The only relationship of this point-of-care standard to the laboratory automation domain is through the use of the HL7 standard. In version 2.4, the HL7 standard was expanded to provide elements essential to laboratory automation, which also improved the HL7 standard for the entire laboratory-testing domain. These additions to HL7, along with four proposed new HL7 message triggers (see Section 4.1 in Appendix C of this CLSI standard), enable the point-of-care community to use HL7 as its electronic data interchange (EDI). This specification also leverages several communication standards. It specifies the use of a single device transport protocol (IrDA TinyTP) running over two possible physical layers: IrDA-infrared, as specified by the Infrared Data Association (IrDA) and ISO/IEEE 11073-303002; and cable-connected, as specified by the IEEE 1073 lower-layers standard. This specification also utilizes local area networking standards such as IEEE 802.3 and protocols such as TCP/IP in cases where network connectivity is required.
Additional Details

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

This document is available in electronic format only.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.

A CLSI-IFCC joint project.

Authors
Lou Dunka, PhD
Bryan Allen
Todd Cooper
Christopher Fetters
Wayne Mullins
James Nichols, PhD
Thomas Norgall
Paul Schluter, PhD
Robert Uleski
Supporting Resources
CLSI POCT01QG
CLSI Vendor Code Registry, 1st Edition
Companion
Point-of-Care Testing
Free