ISO 11073-90101:2008 健康情報学—ポイントオブケア医療機器通信—パート90101：分析機器—ポイントオブケア検査 | ページ 4

Access Point

AP

a subsystem that consolidates data from one or more point-of-care devices (POCD) onto another communication link;

Note 1 to entry: Examples of access points include a multiport concentrator or a dedicated single-port access point, typically connected to a local area network (LAN), or an access point that is part of a multifunctional device such as a patient monitor or personal computer.

ANSI

American National Standards Institute (www.ansi.org).

Clinical Information System

CIS

any healthcare information system (HIS) responsible for housing clinical information;

Note 1 to entry: Examples include laboratory information systems (LIS), clinical data repository (CDR), and electronic medical records (EMR).

Connectivity

the ability to reliably transfer test information between a point-of-care testing device and an information system.

Data Manager

DM

typically, a network server that provides the services of an Observation Reviewer (e.g., POC data storage and forwarding, QA/QC, and other POC instrument and data management functions);

Note 1 to entry: In addition to these services, Data Managers usually provide other applications or services tailored to particular devices or POC user needs (such as regulatory reporting and operator management applications);

Note 2 to entry: Data Manager systems are specific instances of Observation Reviewer services.

Device and Access Point interface

DAP

specifies the interface between a device and an Access Point or concentrator.

Device Messaging Layer

DML

the DML describes a complete messaging protocol (message types and message flow) to exchange results and quality information (quality assurance and quality control) between a Device and an Observation Reviewer;

Note 1 to entry: This protocol may sit on top of any robust, reliable transport, such as the one described by the POCT1 Device and Access Point specification.

Docking Station

a mechanical and electrical interface that supports the use of a POC Device, typically employing legacy mechanical interfaces, connectors, protocols, and power delivery methods.

Electronic Data Interchange

EDI

a term used in many industries to describe protocols to exchange data between enterprise-class information systems;

Note 1 to entry: The acronym is general (applying to all such exchange protocols and languages); however, in some industries it has come to refer to specific implementations;

Note 2 to entry: In the point-of-care domain, this term is occasionally used to refer to the specific interface found between point-of-care data management systems, laboratory information systems, clinical information systems, and other systems that serve as the final repository of POC results.

Extensible Markup Language

XML

a meta-language widely used on the Web and for business-to-business data exchange;

Note 1 to entry: XML is to data and information as HTML is to documents and presentations.

Health Level 7

HL7

the Health Level 7 organization (www.hl7.org), an ANSI-accredited standards development organization focused on messaging to support the exchange of clinical and administrative healthcare data;

Note 1 to entry: The HL7 standard specifies a transport-independent messaging framework and structure that enables disparate healthcare information systems to exchange data.

The Institute of Electrical and Electronics Engineers

IEEE

an international, ANSI-accredited standards development organization dedicated to the advancement of electrical and information technologies;

Note 1 to entry: Among its many roles, the IEEE sets standards for the electronics industry such as IEEE Standard 1073 for Medical Device Communications and IEEE Standard 802.3, which forms much of the lower-layers foundation for the Internet (www.ieee.org).

IEEE 1073

a family of standards for medical device communications that are optimized for the acute care setting;

Note 1 to entry: Devices include patient monitors, ventilators, infusions pumps, pulse oximeters, etc.; standards include IEEE Standard 1073 and lower-layers IEEE Standard 1073.3.2; also referred to as “MIB” (see Medical Information Bus );

Note 2 to entry: These are internationally harmonized as the ISO/IEEE 11073 set of standards.

Infrared

IR

the physical layer typically used by infrared data association (IrDA) devices.

Infrared Data Association

IrDA

an organization that creates and promotes interoperable, low-cost infrared data interconnection standards (www.irda.org);

Note 1 to entry: ‘IrDA’ also refers to the protocol stack authored by that group.

ISO/IEEE 11073

- a family of standards for medical device communications that are optimized for the acute care setting;

Note 1 to entry: When they are harmonized with IEEE 1073 standards, the designation is ISO/IEEE 11073 (see IEEE 1073 ).

Medical Information Bus

MIB

a common name used for the IEEE 1073 family of standards for medical device communications (see IEEE 1073 );

Note 1 to entry: Not to be confused with Management Information Base used in SNMP.

Observation Recipient

the Observation Recipient provides services to manage point-of-care test results and ordering information within a healthcare institution;

Note 1 to entry: In current point-of-care information management solutions, this function is often performed by laboratory information systems, clinical information systems, and other systems that serve as the final repository of POC results.

Observation Reporting Interface

ORI

the ORI specifies messages sent between Observation Reviewers and Observation Recipients;

Note 1 to entry: The messages contain information regarding observation results and associated orders.

Observation Reviewer

the Observation Reviewer provides services to support the management of test results, quality assurance and quality control data, and medical orders;

Note 1 to entry: In current point-of-care information management solutions, this function is often performed by a Data Manager.

Personal Digital Assistant

PDA

the class of consumer electronic devices that handle functions such as management of calendars, contact lists, and task lists;

Note 1 to entry: Examples of PDAs include the Palm™ and Pocket PC™ devices;

Note 2 to entry: Please see Disclaimer Statement in the beginning of this standard.

Point-of-Care

POC

the environment immediately surrounding a patient.

Point-of-Care Coordinator

POCC

an individual who has overall responsibility for assuring that the operation of all POC devices in the institution is compliant with the institution’s POC quality system;

Note 1 to entry: The services provided by the data manager(s) in the system are key tools used by the POC Coordinator to assure compliance.

Point-of-Care Device

POCD

in the context of this standard, a point-of-care device is an instrument used at the patient’s side to measure and/or record a clinical observation;

Note 1 to entry: This definition does not require that the POCD measure the observed value; thus, this definition encompasses devices that perform biochemical analyses, devices that calculate observations from results determined externally, or devices that simply record values determined by other procedures.

Quality assurance

QA

part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000, 3.2.11 ⁵).

Quality control

QC

part of quality management focused on fulfilling quality requirements (ISO 9000 3.2.10⁵).

Tiny Transport Protocol

TinyTP

IrDA transport protocol that provides multiple, concurrent, reliable, bidirectional communication streams on an IrDA link with robust flow control.

Transmission Control Protocol/Internet Protocol

TCP/IP

a transport protocol that provides reliable, bidirectional, stream-oriented network communication;

Note 1 to entry: TCP/IP is one of the foundation protocols of the Internet.