Clinical Chemistry 46: 746-750, 2000;
(Clinical Chemistry. 2000;46:746-750.)
© 2000 American Association for Clinical Chemistry, Inc.
Development of Standards for Laboratory Automation
Charles D. Hawker1,a and
Marc R. Schlank2
1
ARUP Laboratories, Inc., 500 Chipeta Way, Salt Lake City, UT 84108.
2
NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA
19087-1898.
a Author for correspondence. Fax 801-583-2712; e-mail hawkercd{at}arup-lab.com
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Abstract
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In clinical laboratories, the installation of total laboratory
automation systems and/or modular systems has grown
dramatically in the 1990s, particularly in the US, Japan, and
Europe. As the number of installations and level of interest grew,
several individuals and corporations active in the automation field
recognized that the development of prospective standards might enable
customers of such systems or equipment to purchase analyzers,
automation systems or devices, and software from different
vendors and retain interconnectivity of such equipment. These
individuals also believed that the total market for automation systems
and equipment would be significantly greater with standards than
without standards, especially if customers were not forced to purchase
everything from one vendor, and that there might be competitive pricing
and new technology fostered via the standards. This early interest in
standards development led to the initiation of a program by NCCLS in
1996 to develop prospective standards for laboratory automation. Part
of the NCCLS effort has involved interaction and cooperation with other
standards organizations in the US and other countries. This report
describes the current status of the development of prospective
standards for laboratory automation by NCCLS and the relationship of
those standards to those of other standards organizations.
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Introduction
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Since 1990, there has been a rapid increase in the installation of
total laboratory automation systems and/or modular systems,
particularly in the US, Japan, and Europe. Today, there are >170
laboratories in Japan (1), 35 in North America (B. Werner,
Labotix Automation, Inc., Peterborough, Ontario, Canada, personal
communication), and several in Europe with total automation
systems installed or in progress, and many more laboratories with
various forms of modular automation or work cells. In the early 1990s,
several individuals and corporations active in the automation field
recognized that the existence of prospective standards might enable
customers of such systems or equipment to purchase analyzers, devices,
and software from different vendors and retain
interconnectivity of such equipment. This concept is generally referred
to as "plug and play" or "mix and match". Moreover, it was
believed that the total market for automation systems and equipment
would be significantly greater with standards than without standards,
especially if customers were not forced to purchase everything from one
vendor, and that there might be competitive pricing and new technology
fostered via the standards. An ad hoc group, the Clinical Testing
Automation Standards Steering Committee
(CTASSC),1
shown in Table 1
, was formed and began to meet in conjunction with the annual
meetings of the International Conference on Automation and
Robotics and the AACC. The Chair of CTASSC was Dr.
Rodney Markin, Department of Pathology, University of Nebraska.
In 1996, CTASSC approached NCCLS because of NCCLS’s
reputation and success in developing and publishing a wide range of
consensus-based clinical laboratory standards. NCCLS hosted a meeting
on March 13, 1996, to which executives of companies involved in
laboratory automation as well as individuals in academic or laboratory
environments with an interest in automation were invited. Subsequent to
this meeting, which elicited a strong expression of support from the
automation "industry", NCCLS agreed to undertake an aggressive
program for the development of prospective standards. A special
Laboratory Automation Development Fund was created to solicit financial
commitments from instrument and automation system vendors, large and
small; laboratory information system (LIS) vendors; laboratories;
professional organizations; and other users of the technology so that
the standards development program could be "fast tracked" outside
of the usual NCCLS budget process.
In 1996, NCCLS established an Area Committee on Automation, which
consists of some CTASSC members and others. Since 1997, the Area
Committee has formed and directed five separate subcommittees, which
are actively developing standards that cover aspects of automation
ranging from bar code labels, specimen containers (tubes), and carriers
to the electromechanical and computer interfaces between devices,
automation systems, and information systems and various operational
considerations. The five interrelated prospective standards have all
been approved for Proposed Level review with the goal to integrate them
at the Approved Level during the revision process in 2000. More than
230 participants from 30 countries have been involved in this process,
and cooperation and/or codevelopment has occurred with other standards
organizations including Health Level Seven (HL7), the American Society
for Testing and Materials (ASTM), the Japanese Committee for Clinical
Laboratory Standards, the Japanese Society for Clinical Chemistry
(JSCC), and the IFCC.
In addition to reviewing the need for standardization and what
standards can do for consumers of automation systems or equipment, this
presentation will overview the content of the five NCCLS standards,
their current publication/approval status, the relationship with and
involvement of other standards organizations, and NCCLS plans for
future automation standardization activities.
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Need for Standards
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At the NCCLS Executive Advisory Meeting (March 13, 1996,
Arlington, VA), which led to the NCCLS initiative on clinical
laboratory automation standards, Dr. Markin listed the
following as reasons for developing automation standards:
(a) reduction in total costs (including those costs for
development of systems and equipment, costs paid by users or customers,
manufacturing costs, and ultimately the costs paid by patients and
third party payors); (b) improvement or maintenance of
testing quality; (c) reduction in testing redundancy;
(d) advancement in laboratory automation technology;
(e) reduction in installation and service costs;
(f) availability of component-based systems (so-called plug
and play); (g) recognition that no single vendor can
do all; and (h) reduction in training and maintenance. Dr.
Markin also noted that the time was right to initiate standards
development, that there was a high level of interest in such a project
among the stakeholders, that there was no current clinical laboratory
automation group developing standards, and that a formal committee
structure such as that used by NCCLS would ensure coordination between
various worldwide standards groups.
E.J. Stephans (Enterprise Analysis Corporation, Stamford, CT),
in his presentation at the same 1996 meeting, estimated that the annual
worldwide market for clinical laboratory automation products would be
four times greater ($2 billion US vs $0.5 billion) with the advent of
prospective standards that could promote a mix-and-match or
plug-and-play multivendor technology. He likened the prospects for the
impact of automation standards to the development of standards for
electronic mail, which has eliminated the incompatibilities that
existed early in its development. Mr. Stephans noted his belief
that automation is inevitable and will likely occur in stages, that
instrument compatibility with robotics will be an important
consideration, and that systems integration remains a feared nightmare.
He listed several factors that would speed up the implementation of
automation systems, one of which was the development of standards that
promote multivendor, open architecture, mix-and-match installations.
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NCCLS Automation Standards Initiative
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The Area Committee on Automation oversees five subcommittees: the
Subcommittee on Specimen Container/Specimen Carrier (AUTO1); the
Subcommittee on Specimen Identification (AUTO2); the Subcommittee on
Communications with Automated Systems (AUTO3); the Subcommittee on
System Status (AUTO4); and the Subcommittee on Electromechanical
Interfaces (AUTO5). These subcommittees were formed and began meeting
early in 1997. They have typically met in conjunction with the annual
meetings of AACC and the Association for Laboratory Automation (ALA;
these meetings are called LabAutomation ‘98, LabAutomation ‘99, and
so forth) as well as at some other times. As of this report, all five
subcommittees have completed standards that were approved at the
Proposed Level using the NCCLS consensus process by the respective
subcommittee, the Area Committee on Automation, and the NCCLS Board of
Directors, and these Proposed Level Standards have been distributed for
a 6-month period of review and comment. It is expected that all five
standards will be approved in 2000 as Approved Level Standards and that
the process of integrating them will be completed.
subcommittee on specimen container/specimen carrier (auto1)
The mission of this subcommittee was to establish standards for
the specimen containers and carriers so that they will function
optimally in laboratory automation systems (LAS) and to facilitate
compatibility of the specimen carrier with specimen containers and the
electromechanical interface (2). The principal
accomplishments were the selection of four nominal collection container
sizes as standard containers to be supported by laboratory automation
systems—13 x 75 mm, 13 x 100 mm, 16 x 75 mm, and
16 x 100 mm—and the allowance of either single specimen
container carriers or multiple specimen container carriers. Multiple
specimen container carriers are required by the standard to have a
minimum pitch (distance between the centers of adjacent tubes) of
22.0 ± 0.2 mm to provide sufficient room for robotic grippers to
lift the containers from the carriers (Fig. 1
).
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Figure 1. Illustration of the x, y
pitch orientation for a multiple specimen container carrier as defined
in proposed standard AUTO1-P.
The minimum pitch allowed by the proposed standard is 21.8 mm (22 mm
nominal). Equivalent x and y dimensions
are maintained only if pitch and carrier width are the same. Reproduced
with permission of NCCLS, Wayne, PA.
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subcommittee on specimen identification (auto2)
The mission of this subcommittee was to assure that identification
of specimen container bar codes will be effective in automated
laboratory systems (3). The proposed standard defines the
way bar-coded specimen identification labels are applied to clinical
specimen containers. It documents the form, placement, and content of
bar code labels on specimen container tubes that are used on clinical
laboratory analyzers, and the specification also meets the requirement
for laboratory automation systems, thus enabling the production of
reliable bar coded symbols that are readable by any complying clinical
laboratory analyzer and automation system. The standard uses Code 128
(4), a bar code symbology that accommodates many different
languages, and recommends phasing out all other types of symbologies by
the year 2003. In addition, the placement of the label was recommended
to be 9 mm from the bottom and 10 mm from the top of the specimen
container, with a total of no more than four labels, including the
manufacturer’s label, applied to the tube (Fig. 2
).
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Figure 2. Illustration of the bar code symbol read and placement
zones on a tube of any length (lengths determined by standard AUTO1-P)
as defined by the proposed standard AUTO2-P.
Minimum distances from the top and bottom of the tube for both the
placement of the label and the position of the symbol (bar code) are
defined in this standard. Reproduced with permission of NCCLS, Wayne,
PA.
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subcommittee on communications with automated systems (auto3)
The mission of this subcommittee was to provide a protocol for
communications between the LAS, LIS, automated instruments (analyzers),
and pre- and postanalytical automated devices (5). The
standard focuses on both the characteristics of the communications
(low-level protocol) and the data to be transferred (high-level
protocol). The low-level protocol was developed to meet the band width
and time characteristics required by automation. The high-level
protocol defines specific messages and data to be transferred in
automated communications. Furthermore, it was recognized that there are
old protocols in use in clinical laboratories that are not supported by
the standard. Because the overall intent of the standard is to be
prospective in nature and to meet anticipated future needs for
automation, of necessity it focuses on protocols that can meet the time
and data characteristics for automation systems, and older (legacy)
systems are not supported, although they are not necessarily excluded.
Fig. 3
diagrams the architecture or communications relationships
between elements in a laboratory automation environment supported by
this standard. Not all elements are required for implementation of the
standard. As shown in the Fig. 3
, separate, direct communication
between the analyzer and a LIS is permitted without involving the LAS.
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Figure 3. Illustration of the communications flow between the
different computers (or computers contained within various instruments)
that may be involved in a laboratory automation environment as defined
by the proposed standard AUTO3-P.
Not all elements are required, and some systems may combine the
functions of a LAS and a LIS into the same computer. This model is
called the Functional Control Model by the proposed standard.
Reproduced with permission of NCCLS, Wayne, PA.
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Early in the discussions of this subcommittee, it was concluded that
one existing standard then in wide use by instrument manufacturers,
ASTM 1394 (6), lacked sufficient scope and flexibility to
meet the needs for total laboratory automation. Among other issues,
this standard specified a low-level protocol that lacked the band width
and time characteristics required by automation, and it did not specify
the unique messages required for communications between the elements in
an automation environment. At approximately the same time, JSCC
provided to the subcommittee, through one of its members serving in
both groups, a set of modifications to ASTM 1394 that JSCC believed
would improve the ASTM standard. The NCCLS subcommittee passed these
recommendations on to ASTM but felt that the ASTM 1394 standard, even
if the JSCC modifications were adopted, still would not meet the
perceived requirements for laboratory automation.
Moreover, the subcommittee recognized that the HL7 Standard
(7) for electronic data exchange in all healthcare
environments was not only widely used for communications within the
healthcare community, but it was increasingly being adopted by LAS
vendors to meet their communications needs. Thus, the subcommittee
voted to use the HL7 format for a chapter that would comprise the
high-level protocol of the standard. This chapter would specify new HL7
triggers, messages, and segments that the subcommittee believed were
required for implementation of clinical laboratory automation
communication interfaces.
To avoid violating HL7’s copyrights, the Chair of the NCCLS
Subcommittee on Communications with Automated Systems contacted HL7,
which led to the formation of a Special Interest Group (SIG) on
Laboratory Automation within the HL7 organization. This SIG has held
several meetings within the HL7 meetings, leading to finalization of
this proposed chapter of messages, triggers, and segments for
laboratory automation. The Co-Chairs and principal participants on the
HL7 SIG were also the key individuals on the NCCLS subcommittee, which
brought consistency to this project. This proposed chapter would be a
new HL7 chapter (Chapter 13) in the next HL7 version (Ver. 2.4) to be
balloted to HL7 members in December 1999, with the approval process
completed in early 2000 (8).
The control model in the NCCLS proposed standard is an extension of the
model described in another standard, Laboratory Equipment Control
Interface Specification (LECIS) (9). The difference between
the two models is that the NCCLS model includes provisions for
communication between modules, not just between controller and module.
In the LECIS standard, the definition of "equipment" includes the
NCCLS definitions of both process instruments and analytical
instruments. The LECIS standard describes a set of standard equipment
behaviors that must be accessible under remote control to facilitate
set up and operation of laboratory equipment in an automated
laboratory. Details of the NCCLS standard’s application of the LECIS
standard are contained in the NCCLS document (5), and a
table of the standard equipment behaviors from LECIS as adapted to the
laboratory automation standards are contained in the NCCLS AUTO4
standard discussed below.
subcommittee on system status (auto4)
The mission of this subcommittee was to delineate the operational
requirements, characteristics, and information elements required to
define the status of instruments and/or specimen processing/handling
devices connected to and interacting with the LAS (10). The
intent of the standard is to facilitate the compatibility between the
instruments and/or specimen processing/handling devices and the LAS.
The standardized system status information exchange should facilitate
continuous, uninterrupted operation of the LAS with appropriate human
intervention. Among many tables contained in this standard is a table
of equipment states based on the LECIS standard (9) as
discussed in the paragraph above. The standard also defines specimen
quality measures, quality control, calibration, nomenclature, and
inventory elements.
subcommittee on electromechanical interfaces (auto5)
The mission of this subcommittee was to define a
standard-compatible connection between instruments and automated
technology to create an automated laboratory environment that will
function optimally for the individual laboratory (11). This
standard establishes specifications for a "Point of Reference"
(POR) that can be used by manufacturers of automated analyzers, process
equipment and devices, and automation systems involving conveyors or
tracks, robotic carts, or other transport devices to orient against so
that one device can locate and access a specimen transported by another
device. The standard specifies the height from the floor, the distance
from the instrument, the location of the specimen container, and
permits the use of false-bottom tubes and specimen cups. Fig. 4
is a graphic representation of the POR and the specimen
container, showing the various dimensions and clearance zones relative
to the floor and an analyzer as defined in the standard.
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Figure 4. Illustration of the POR for use by manufacturers of
automated analyzers and automation systems to be able to mechanically
interface their systems to each other.
In addition to the height from the floor, the proposed standard AUTO5-P
also defines other essential clearances or distances to facilitate
these interfaces. Reproduced with permission of NCCLS, Wayne, PA.
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Path Forward for NCCLS Laboratory Automation Standards
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Two of the five Proposed Level NCCLS standards (AUTO2 and AUTO3)
completed 6-month comment periods at the end of June 1999. AUTO1 will
complete that period at the end of January 2000, and AUTO4 and AUTO5 at
the end of April 2000. After revisions to each standard to incorporate
input received during the respective comment periods have been made,
these five standards for laboratory automation will be integrated and
published later in 2000 as Approved Level standards.
In the usual NCCLS process, subcommittees are "disbanded" after
publication of their Approved Level standards, and each area committee
assumes responsibility, ~5 years later, to review its standard for
consideration of updating or revising information relevant to the needs
of newer technologies being utilized. In the past, NCCLS standards
applied to "mature" procedures or technologies that usually were
not evolving rapidly. Because the automation standards are prospective
in nature and do apply to a technology that is evolving rapidly, there
are more issues that could be addressed in these standards that would
make the standards more beneficial for both manufacturers and users.
Therefore, updates are planned for cycles of 2–3 years instead of the
typical NCCLS 5-year cycle. Among the possible extensions of the
laboratory automation standards are standards for automation of
pharmaceutical analytical laboratories.
The NCCLS project to develop prospective standards for laboratory
automation has been highly successful. Active participation in the
drafting of the five Proposed Level standards was obtained from >230
participants in 30 countries, and cooperation was obtained from several
other standards organizations. These prospective NCCLS standards will
guide laboratorians seeking to automate their laboratories and
manufacturers of automation equipment and automated analyzers, as well
as facilitating continued progress in this field.
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Footnotes
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1 Nonstandard abbreviations: CTASSC, Clinical Testing Automation Standards Steering Committee; LIS, laboratory information system(s); HL7, Health Level Seven; ASTM, American Society for Testing and Materials; JSCC, Japanese Society for Clinical Chemistry; LAS, laboratory automation system(s); SIG, Special Interest Group (HL7); LECIS, Laboratory Equipment Control Interface Specification (ASTM); and POR, Point of Reference. 
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References
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. NCCLS. Laboratory automation: specimen container/specimen carrier; proposed standard 1999:1-20 NCCLS NCCLS Document AUTO1-P [ISBN 1-56238-378-7]. Wayne, PA. .
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. ANSI/AIM. BC4-1995 1995 American National Standards Institute/Automatic Identification Manufacturers Uniform symbology specification, code 128. Pittsburgh, PA. .
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. American Society for Testing and Materials. Laboratory equipment control interface (LECI) specification 1998 American Society for Testing and Materials ASTM E49.52. Philadelphia, PA. .
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. NCCLS. Laboratory automation: electromechanical interfaces; proposed standard 1999:1-28 NCCLS NCCLS Document AUTO5-P [ISBN 1-56238-390-6]. Wayne, PA. .
The following articles in journals at HighWire Press have cited this article:
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Clin. Chem.,
December 1, 2005;
51(12):
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Abstract
Introduction
