ISO 11073-90101:2008

Health informatics — Point-of-care medical device communication — Part 90101: Analytical instruments — Point-of-care test

ISO 11073-90101:2008 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 POCT1 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, ISO 11073-90101:2008 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 International Standard does not directly address specific point-of-care application and service level functions, such as device lockout and operator list management. It 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.

Informatique de santé — Communication entre dispositifs médicaux sur le site des soins — Partie 90101: Instruments analytiques — Essai sur le site des soins

General Information

• Status: Published
• Publication Date: 07-Jan-2008
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 9093 - International Standard confirmed
• Start Date: 20-Nov-2023
• Completion Date: 12-Feb-2026

Overview

ISO 11073-90101:2008 - Health informatics: Point-of-care medical device communication - Part 90101: Analytical instruments - Point-of-care test - is an interface specification that enables seamless, multivendor interoperability for point-of-care (POC) devices. Published by ISO and derived from CLSI document POCT1-A2, this standard defines the common communication interfaces and protocols used for bidirectional data exchange between POC analytical instruments, access points/data concentrators, and clinical information systems (for example, laboratory information systems and hospital EHRs). It specifies protocol behavior (not institutional policy or application-level services) to support development of POC applications, services and integrations.

Key Topics

• Multivendor interoperability: Framework enabling devices from different manufacturers to communicate reliably with data managers and clinical systems.
• Common communication interfaces and protocols: Defined interface layers and messaging constructs to standardize device-to-system communication.
• Device messaging layer: Topics and message “scripts” for transmitting test results and device metadata (examples include typical test-result messages).
• Lower-layer networking considerations: Guidance on networking evolution and transport layers to support device connectivity.
• Bidirectional communication: Support for both device-to-system reporting and system-to-device commands (e.g., configuration, queries).
• Protocol (not policy): Clarifies that application-level policies such as device lockout or operator management are out of scope; the standard provides the communication plumbing for such features.

Applications / Who Uses It

ISO 11073-90101:2008 is primarily used by:

• Medical device manufacturers (POC analytical instruments like glucose meters, blood gas analyzers) designing connectivity features.
• Healthcare IT and LIS/EHR vendors integrating POC results into clinical workflows.
• Middleware and data concentrator developers building bidirectional interfaces and data aggregation solutions.
• Clinical engineers and systems integrators implementing multivendor point-of-care connectivity in hospitals and laboratories.
• Regulatory and procurement teams evaluating interoperability capabilities for point-of-care testing (POCT) deployment.

Practical benefits include reduced integration cost, more reliable POC data capture, consistent result formats for clinical decision support, and faster deployment of point-of-care services.

Related Standards

• CLSI POCT1-A / POCT1-A2 - Source framework adopted into ISO 11073-90101.
• Other parts of the ISO 11073 family (device communication standards) and complementary healthcare IT standards (e.g., HL7 messaging for clinical systems) - used together to achieve end-to-end interoperability.

Keywords: ISO 11073-90101:2008, point-of-care connectivity, POCT, analytical instruments, medical device communication, interoperability, CLSI POCT1, data concentrator, laboratory information systems, healthcare IT.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 11073-90101
First edition
2008-01-15
Health informatics — Point-of-care
medical device communication —
Part 90101:
Analytical instruments — Point-of-care
test
Informatique de santé — Communication entre dispositifs médicaux sur
le site des soins —
Partie 90101: Instruments analytiques — Essai sur le site des soins

Reference number
©
ISO 2008
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
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Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 11073-90101 was prepared by the Clinical and Laboratory Standards Institute (as POCT1-A2) and was
adopted, under a special “fast-track procedure”, by Technical Committee ISO/TC 215, Health informatics, in
parallel with its approval by the ISO member bodies.

POCT1-A2
Vol. 26 No. 28
Replaces POCT1-A
Vol. 21 No. 24
Point-of-Care Connectivity; Approved
Standard—Second Edition
This document provides the framework for engineers to 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.
A standard for global application developed through the Clinical and Laboratory
Standards Institute consensus process.

(Formerly NCCLS)
Clinical and Laboratory Standards Institute
Advancing Quality in Healthcare Testing

The Clinical and Laboratory Standards Institute (CLSI, Most documents are subject to two levels of consensus—
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testing and related healthcare issues. Our process is
and thorough technical review, including an overall review
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cost-effective way to improve patient testing and
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POCT1-A2
ISBN 1-56238-616-6
Volume 26 Number 28                                     ISSN 0273-3099
Point-of-Care Connectivity; Approved Standard—Second Edition

Lou Dunka, PhD
Bryan Allen
Todd Cooper
Christopher Fetters
Wayne Mullins
James Nichols, PhD
Thomas Norgall
Paul Schluter, PhD
Robert Uleski
Abstract
Clinical and Laboratory Standards Institute document 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. 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.

Clinical and Laboratory Standards Institute (CLSI). Point-of-Care Connectivity; Approved Standard—Second Edition. CLSI
document POCT1-A2 (ISBN 1-56238-616-6). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400,
Wayne, Pennsylvania 19087-1898 USA, 2006.

The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through
two or more levels of review by the healthcare community, is an ongoing process. Users should expect revised editions of any
given document. Because rapid changes in technology may affect the procedures, methods, and protocols in a standard or
guideline, users should replace outdated editions with the current editions of CLSI/NCCLS documents. Current editions are
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not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: [phone]; Fax:
610.688.0700; E-Mail: [e-mail]; Website: www.clsi.org

(Formerly NCCLS)
Number 28 POCT1-A2
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Suggested Citation
(Clinical and Laboratory Standards Institute. Point-of-Care Connectivity; Approved Standard—Second
Edition. CLSI document POCT1-A2 [ISBN 1-56238-616-6]. Clinical and Laboratory Standards Institute,
940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006.)

Proposed Standard
May 2001
Approved Standard
December 2001
Approved Standard—Second Edition
July 2006
ISBN 1-56238-616-6
ISSN 0273-3099
ii
Volume 26 POCT1-A2
Committee Membership
Area Committee on Point-of-Care Testing

Louis J. Dunka, Jr, PhD Raelene M. Perfetto, MBA, Ellis Jacobs, PhD, DABCC, FACB
Chairholder MT(ASCP) New York State Dept. of Health
LifeScan, Inc. Centers for Medicare & Medicaid Albany, New York
Services
Milpitas, California
Baltimore, Maryland David Klonoff, MD
James H. Nichols, PhD, DABCC, Diabetes Technology Society
Kathy Scruggs, MT(ASCP) Foster City, California
FACB
Vice Chairholder Dayton VA Medical Center
Baystate Medical Center Dayton, Ohio Katsuhiko Kuwa, PhD
University of Tsukuba
Springfield, Massachusetts
Patrick J. St. Louis, Ph.D., Dip.CC Tsukuba 305-8575, Japan
Diana R. DeHoyos, MS, MT(ASCP) Ste. Justine Hospital
The University of Texas Medical Montreal, Quebec Ronald H. Ng, PhD, DABCC, FACB
Branch Abbott Diabetes Care
Galveston, Texas Advisors Alameda, California

Christopher Fetters Jeff Dahlen, PhD Carmina Pascual, MT(ASCP),
NOVA Biomedical Biosite Incorporated CLS(NCA)
Waltham, Massachusetts San Diego, California Roche Instrument Center AG
Rotkreuz, Switzerland
George W. Gaebler, III, MSEd., RRT, Sharon S. Ehrmeyer, PhD
FAARC University of Wisconsin David L. Phillips
University Hospital Madison, Wisconsins HemoSense, Inc.
Syracuse, New York San Jose, California
Valerio M. Genta, MD
Ethan D. Hausman, MD, FAAP, Sentara Virginia Beach General Paula J. Santrach, MD
FCAP Hospital Mayo Clinic
FDA Ctr. for Devices/Rad. Health Virginia Beach, Virginia Rochester, Minnesota
Rockville, Maryland
Barry H. Ginsberg, MD, PhD Lou Ann Wyer, MT(ASCP)
Frank M. LaDuca, PhD BD Sentara Healthcare
Bayer HealthCare Diagnostics Franklin Lakes, New Jersey Norfolk, Virginia
Division
Tarrytown, New York
Working Group on Point-of-Care Connectivity

Louis J. Dunka, Jr, PhD Todd Cooper James Nichols, PhD
Chairholder Breakthrough Solutions, Inc. Baystate Medical Center
LifeScan, Inc. (Representing IEEE) (Representing CLSI)
Milpitas, California Poway, California Springfield, Massachusetts

Joanna C. Baker, MSPH, Christopher Fetters Thomas Norgall
MT(ASCP)SC, C NOVA Biomedical Institut Integrierte Schaltungen
Moncrief Army Community Hospital Waltham, Massachusetts Erlangen, Germany
Ft. Jackson, South Carolina
Andrzej J. Knafel, PhD Carmina Pascual, MT(ASCP),
Chris Budgen Roche Instrument Center CLS(NCA)
Canterbury Health Laboratories (Representing HL7) Roche Instrument Center AG
Christchurch, New Zealand Rotkreuz, Switzerland Rotkreuz, Switzerland

James Callaghan Wayne Mullins Phil Pash
FDA Center for Devices/Radiological Medical Automation Systems Roche Diagnostics
Health Charlottesville, Virginia Indianapolis, Indiana
Rockville, Maryland
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Number 28 POCT1-A2
Working Group (Continued)
Melvin I. Reynolds Andrew St. John Staff
AMS Consulting ARC Consulting
Ross-on-Wye Mt. Lawley, Washington Clinical and Laboratory Standards
Herefordshire, United Kingdom Institute
Andreas Staubert, PhD Wayne, Pennsylvania
Christina Rode-Schubert, MBA Roche Diagnostics GmbH
BE Consult Mannheim, Germany John J. Zlockie, MBA
Heidelberg, Germany Vice President, Standards
William Thorpe
Paul Schluter, PhD Bayer David E. Sterry, MT(ASCP)
GE Medical Systems Information Norwood, Massachusetts Staff Liaison
Technologies
(Representing IEEE) Robert Uleski Donna M. Wilhelm
Milwaukee, Wisconsin Robert Uleski Consulting Editor
Fishers, Indiana
Allan Soerensen Melissa A. Lewis
Radiometer Medical Aps Assistant Editor
Broenshoej, Denmark
Acknowledgement
CLSI gratefully acknowledges the contributions of the late Dr. Louis J. Dunka, Jr., LifeScan, Inc, who
served as the Chairholder of the Area Committee on Point-of-Care Testing and was an active participant
on the Working Group on Point-of-Care Connectivity during the revision of this document.
iv
Volume 26 POCT1-A2
Contents
Abstract.i
Committee Membership. iii
Foreword.ix
1 Scope.1
2 Introduction.1
3 Definitions .2
4 Specifications.4
4.1 Description of Connectivity System Components.5
4.2 The Interfaces .6
References.15

Figures
Figure 1. Cooperative Evolution of Point-of-Care Standards. 2
Figure 2. The Two Interfaces. 5
Figure 3. Device Interface Layers. 7
Figure 4. Lower-Layer Networking Evolution . 8
Figure 5. Device Messaging Layer Data Topics. 8
Figure 6. Device Messaging Layer ‘Script’ . 10
Figure 7. Example Glucose Test Results Message . 11
Figure 8. Example Access Point Deployment Scenario. 12
Figure 9. Observation Reporting Interface . 13
Figure 10. Sample Observation Reporting Interface Message. 14

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Number 28 POCT1-A2
Contents—Appendixes
Appendix A. Device and Access Point (DAP) Interface Specification
1 Scope and Introduction. 25
2 Definitions. 25
3 Abbreviations . 27
4 Overview of POC Device Networking (Informative) . 28
5 Overview of IrDA and ISO/IEEE 11073-30200 (Informative). 30
6 Requirements for a ‘POCT1-compatible’ Device (Normative). 36
7 Requirements for a ‘POCT1-compatible’ Access Point (Normative) . 38
8 Networked Access Points (Normative if Implemented). 41
9 Remote Modem Access (Informative) .47
10 POC Devices With Direct Network Connections (Informative) . 48
11 Data Security (Informative) . 49
12 RF Wireless Networking Technologies (Informative) . 50
13 References . 53
Appendix B. Device Messaging Layer (DML) Specification
1 Scope and Introduction . 63
2 Bidirectional Communication. 66
3 General Messaging Issues . 71
4 Messaging Profile . 76
5 Information Model . 91
6 Messaging Model . 110
7 Extending the Device Messaging Layer. 126
8 Annex A. Device Messaging Layer Data Types (Normative). 128
9 Annex B. Asynchronous Observation Acknowledgements (Normative) . 138
10 Annex C. 'SET-TIME' Time Stamp and Time Zone Information . 139
11 Annex D. Example Messages (Informative) . 144
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Volume 26 POCT1-A2
Contents—Appendixes (Continued)
12  Annex E. POCT1 Messaging DTDs (Normative). 171
Appendix C. Observation Reporting Interface (ORI) Specification
1 Scope and Introduction .203
2 Use Case Descriptions.203
3 Message Profile .205
4 HL7 Message Definition .208
5 Sample Messages .223
Appendix D. Point-of-Care Requirements
1 Requirements .257
Appendix E. Connectivity Architecture
1 Architecture . 275
2 Principles. 275
3 Approach. 277
4 Model . 278
Appendix F. Vendor Codes
1 Vendor Codes . 283
Summary of Comments and Subcommittee Responses. 285
The Quality System Approach. 288

Related CLSI/NCCLS Publications . 289

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viii
Volume 26 POCT1-A2
Foreword
Over the last decade, advances in microfluidic and other miniaturization technologies have enabled a new
class of diagnostic device. This new device class—point-of-care diagnostic—supports a wide diversity of
diagnostic testing directly at the point of care. Tests that had been previously limited to the domain of
central laboratory analyzers are now available in a variety of care settings. Sophisticated tests are possible
at the hospital bedside, during patient encounters in primary- and secondary-care clinics, and even in the
home. This new point-of-care diagnostic device class offers the advantages of fast turnaround time for test
results and quite possibly cost reduction for some types of tests.

In general, from a regulatory perspective, a diagnostic test is not differentiated based on where the test is
performed. Someone in the institution must be able to show that the test was performed in compliance
with the policies of an overall diagnostic testing quality system for the institution. It is thus incumbent
upon point-of-care diagnostic device vendors to offer mechanisms by which their devices may be
integrated into an institution’s diagnostic information management system. It is this requirement for
integration that drives the need for standardization.

To date, point-of-care diagnostic vendors and partners have faced this integration problem individually
and have derived unique solutions. Any institution embarking on incorporating multivendor point-of-care
diagnostic devices into their diagnostic testing facilities has had to face the equipment and management
costs of multiple integration solutions. In fact, the cost and disjointedness of multivendor point-of-care
diagnostic integration is seen as a significant barrier to the adoption of this new and exciting class of
diagnostic device.
For the purposes of this specification, point-of-care testing is defined as all testing conducted near the site
of patient care. This encompasses many different environments, including hospital-based testing, near-
patient testing, physician’s-office testing, and patient self-testing. A point-of-care connectivity
specification must be applicable to all of these settings.

In February 2000, 49 healthcare institutions, point-of-care diagnostic vendors, diagnostic test system
vendors, and system integrators formed the Connectivity Industry Consortium (CIC) to address this point-
of-care diagnostic integration problem. The CIC Board of Directors created the following statement to
guide the CIC work teams:
“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 result is a set of standards that will become the foundation for POC connectivity across the healthcare
continuum. To meet this vision, the resulting standards are self-sustaining and utilize practical, cost-
effective, user-focused solutions. The desired outcome of this vision is broad-based vendor and provider
a
adoption of the CIC standards.

Sections 1 through 4 of this document introduce and explain the technical aspects of point-of-care
connectivity specifications. Appendixes A through C are the specifications for constructing a connectivity
system; Appendixes D and E describe the basic concepts CIC employed to develop this standard.

a
The governing principles, guidelines, timeline, and other information about the CIC can be found at the CIC’s website:
www.poct.fraunhofer.de/about/index.html. The CIC development process emulated the standards-development processes of
ANSI-approved standards organizations.

ix
Number 28 POCT1-A2
Foreword (Continued)
TM TM
Note that the following trade names are included in this document: Palm , Pocket PC , and
TM
Bluetooth . It is CLSI policy to avoid using trade names unless the products identified are the
only ones available; they serve as an example of the point illustrated in the consensus document;
and there is no generic description of the design and functional features of the products. Inclusion
of these trade names in no way constitutes endorsement by CLSI. Please include in your comments
any information that relates to our adherence to this trade name policy.

Connectivity Industry Consortium Membership

CORE VENDORS CORE PROVIDERS
Abbott Laboratories Banner Health System
Agilent Technologies Bradford Royal Infirmary
Bayer Diagnostics Geisinger Healthcare System
BD John Hopkins Medical Institutions
Instrumentation Laboratory Kaiser Permanente
Lifescan/J&J Mayo Clinic
Medical Automation Systems Profil GmbH
Radiometer Medical St. Vincent Mercy Medical Center
Roche Diagnostics The Mount Sinai Hospital
Sunquest Information Systems University of Iowa Healthcare

SUPPORTING VENDORS INDIVIDUAL PROVIDERS
Abaxis Maurice Green, PhD
Avocet Medical Neil Halpern, MD
Cerner Georg Hoffmann
Clarinet Systems Colonel Forrest Kneisel
Comtrol Corporation Gerald Kost, MD, PhD
First Medical/Sigma Diagnostics Petrie Rainey, MD PhD
GE Medical Systems Information Technologies
HemoCue LIAISONS
HemoSense AACC
InterComponentWare COLA
i-STAT Corporation IFCC Scientific Division
International Technidyne Corporation (ITC) Medical Devices Agency
Lantronix
Medtronic
Motorola
Orasure Technologies, Inc.
Pharmacia & Upjohn
SMS/Siemens
TELCOR Inc
x
Volume 26 POCT1-A2
Foreword (Continued)
The CIC worked within a “fast-track” model and developed the point-of-care diagnostic integration
specification within its planned 12- to 15-month lifetime. The CIC organization then handed the
specification to CLSI (www.CLSI.org), Health Level 7 (www.hl7.org), and IEEE (www.ieee.org)
organizations for subsequent maintenance and extension.

This document, then, represents the work product of the Connectivity Industry Consortium (CIC).

Since the initial publishing of the CLSI POCT1-A standard, communication technologies have evolved,
including in the area of radio frequency (RF) networking. The current POCT1 standard makes numerous
references to both Bluetooth (802.15.1) and WiFi (802.11) transport interfaces; however, at that time it
wasn’t clear whether one technology should be chosen in favor of another. As a result, though RF
wireless networking is mentioned in the document, there is no clear direction other than that the standard
should be easily extended to include one or more of these transport technologies as long as they provide
reliable connection-oriented communications.

This document replaces the first approved edition, POCT1-A, which was published in 2001. Several
changes have been made in this edition; chief among them is the addition of a new section related to RF
Wireless Networking Technologies (see Section 12 in Appendix A). Another significant change in this
document is the conversion of each message prefix from “NCCLS” to “CLSI.” This change has been
made to reflect the organizational name change that has occurred since the original publication of this
standard. In the case of manufacturers with existing or distributed implementations that used the
“NCCLS” prefix, the “NCCLS” prefix is a deprecated but valid string, in addition to the preferred
“CLSI.”
CLSI also gratefully acknowledges the approval of POCT1 by the Scientific Division of the International
Federation of Clinical Chemistry and Laboratory Medicine (IFCC). The joint efforts of the AACC Point-
of-Care Testing Division, CIC, HL7, IEEE, IFCC, and CLSI, along with the many committee participants
and experts involved in the development of POCT1, have served to strengthen the value of this standard
and its usefulness worldwide.
xi
Number 28 POCT1-A2
Acknowledgements
Many individuals contributed a tremendous amount of time and effort to the CIC toward developing,
describing, and reviewing these point-of-care connectivity specifications.

The following individuals served technical organizational roles within the consortium:
Chief Technical Officer: Jeff Perry, Walker Informatics
Architecture Team: Jack Harrington, Philips Medical Systems
Device Team Co-Chairs: Alan Greenburg, Roche Diagnostics
Bob Uleski, FluorRx
EDI Team Co-Chairs: Rodney Kugizaki, LifeScan
Wayne Mullins, Medical Automation Systems
Point-of-Care Workflow: Marcy Anderson, Medical Automation Systems
Teresa Prego, Bayer Diagnostics
Requirements Team:
The following individuals are recognized for their significant contributions to the development, authoring,
and review of the original CIC Specification:

• Bryan Allen, Bayer Diagnostics
• Bob Anders, HealthWyse
• Nils Graversen, Radiometer Medical
• Alan Greenburg, Roche Diagnostics
• Jack Harrington, Philips Medical Systems
• Rodney Kugizaki, LifeScan
• David Ma, Clarinet Systems
• Mark Maund, i-STAT Corporation
• Chris Melo, Philips Medical Systems
• Wayne Mullins, Medical Automation Systems
• Dan Nowicki, GE Medical Systems Information Technologies
• Joe Rogers, i-STAT Corporation
• Paul Schluter, GE Medical Systems Information Technologies
• Allan Soerensen, Radiometer Medical
• Dan Trainor, Philips Medical Systems
• Imre Trefil, LifeScan
• Bob Uleski, FluorRx
Key Words
Access point, connectivity, device interfaces, diagnostics, diagnostic devices, HL7, IrDA, IEEE 1073,
ISO 11073, medical information bus, MIB, CLSI, point-of-care, POC, point-of-care testing, POCT
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Volume 26 POCT1-A2
Point-of-Care Connectivity; Approved Standard—Second Edition

1 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 POCT1 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 11073-30300 ; 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.

2 Introduction
This document on point-of-care connectivity has been developed by the CLSI Subcommittee on Point-of-
Care Connectivity. The core of the standard is a group of three specifications developed by the
Connectivity Industry Consortium (CIC). The specifications describe the attributes of an access point; the
communication protocols between the device and the access point; and communications between a data
manager and clinical information systems. The collaborative effort among providers and manufacturers
has produced a set of specifications acceptable to both. The constitution of the subcommittee is a balance
among providers; representatives of CLSI, HL7, and IEEE; the professions (CAP); and the government
(FDA). The specifications will become standards in IEEE, HL7, and CLSI in parallel.
©
Clinical and Laboratory Standards Institute. All rights reserved.
Number 28 POCT1-A2
CIC Technical Publication
Device and
Device and
ISO/IEEE
IEEE IEEE 10731073
IEEE 1073
Access Point
Access Point
Device
NCCLSNCCLSNCCLS
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NCCLSNCCLSCLSI
CLSI NCCLS POCTPOCT
CLSI POCT
NCCLS POCT
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Messaging Layer
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Observation
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Figure 1. Cooperative Evolution of Point-of-Care Standards

3 Definitions
Access Point (AP) – a subsystem that consolidates data from one or more point-of-care devices (POCD)
onto another communication link; NOTE: 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: 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: 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: 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: 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: 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: In the point-of-care domain, this term is occasionally used to refer to the
©
Clinical and Laboratory Standards Institute. All rights reserved.
Volume 26 POCT1-A2
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: 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: 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: 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: Devices include patient monitors, ventilators, infusions pumps, pulse oximeters,
etc.; stand
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