CLSI GP19-A2-2003

The scope of this document is limited to issues that affect ease
of learning and the ease of use of software user interfaces.
Although there is a need to improve the hardware interface between
operators and instruments (e.g., keyboard, mouse, touch screen,
printer, reports, voice, and light pens used when adding or
removing patient samples, reagents, and waste), these topics are
not within the scope of this guideline. GP19-A2 is not intended as
a tool to be used in the selection, recommendation, or judgment of
the suitability of specific input/output technologies, since these
may change rapidly. Since it is described elsewhere,1,2 the
transfer of electronic information between information and/or
automation systems (such as between a laboratory information system
or laboratory automation system software and an instrument) is not
the subject of this document.

This document identifies the most important factors that
designers and laboratory managers should consider during the
development of a new software-actuated system and when selecting a
software user interface intended to improve the ease of learning
and use within the clinical laboratory. Without attempting to
provide a comprehensive or exhaustive discussion of software user
interfaces or trying to define an identical appearance for user
interfaces by describing a single, detailed design solution, this
document addresses some common design elements. This discussion is
intended to encourage manufacturers of laboratory instruments and
specimen handling devices to develop more uniform software user
interfaces within their product lines.

The primary focus of this document is the software user
interface within the centralized laboratory environment. The
guidelines presented in this document are not directly constructed
for point-of-care, physician-office, or over-the-counter devices,
although many of the principles discussed apply to these devices as
well. The primary focus of this document is software user
interfaces on instruments, although the guidelines also apply to
interfaces on laboratory systems and other associated information
systems used in the laboratory.

These design guidelines and examples are not, however,
universally applicable to all laboratory systems. Implementation of
a specific design depends on the size, complexity, and cost of a
device, as justified by its intended use.

This document provides some simple rules to help laboratory
personnel prepare validation protocols that fulfill the
laboratory's obligation to test and verify the functionality and
dependability of its software. This document does not advocate
relieving software developers of their duty to validate the
software products that they develop; GP19 offers assistance to the
purchaser when no other means of validation is available.
Developers should refer to sources such as IEEE sources for
specific guidelines for software system
validation.^3,4