ASTM-E792 1995

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E792-95e1 Standard Guide for Selection of a Clinical Laboratory Information Management System

Published By	Publication Date	Number of Pages
ASTM	1995	32

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Categories: 35.240.80 - IT applications in health care technology, ASTM

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Description

ASTM E792-95e1

Historical Standard: Standard Guide for Selection of a Clinical Laboratory Information Management System

ASTM E792

Scope

1.1 This guide covers the selection, purchase, use, enhancement, and updating of computer technology supplied by a vendor as a complete system in the clinical laboratory. The purpose of the guide is to assist hospitals, clinics, and independent laboratories through the entire automation project in order to minimize the risks and maximize the benefits. It provides a process that may be used by the medical institution to carry out laboratory information projects in a rational and orderly manner. It also includes checklists of items to be considered at each stage of planning to help guard against the unpleasant consequences of oversights. It includes planning and design aids to assist in carrying out the project. In addition, there is information (see Section 18) about enhancement and updates after the system is purchased.

Note 1—The term “stat,” as used in this guide is the abbreviation for the Latin word statim, which means immediately.

1.2 This guide is not concerned with digital or computer electronics used only within instrumentation. Rather, it deals with the application of information systems to a large segment of the laboratory operation, and generally is concerned with how Information and Communications Technology (ICT) can be used to enhance the interaction of the laboratory with the rest of the institution, improve workflow in the laboratory, and help keep records. Such systems will normally include segments for patient biographical information, test ordering, specimen collection, workstations worklists, test result entry, result verification, patient result reporting, management reports, archiving, and other special functions.

1.3 The major topics are found in the following sections:

1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Keywords

clinical laboratory; functional requirements; laboratory test ordering; laboratory work management; software acquisitions; software life cycle; software project; software requirements

ICS Code

ICS Number Code 35.240.80 (IT applications in health care technology)

DOI: 10.1520/E0792-95E01

Additional information

Evaluation of Vendor Proposals	11
Admission-Discharge-Transfer	6.2
Vendor Survey	7
Warranty	11.3
Requests for Proposals	10
Documentation of Maintenance	17.3
Selection of Option	5.5
Reports	6.7
Maintenance	11.4
Test Performance	6.6
Functional Requirements	6
Evaluation of Vendors	11.11
Test Ordering	6.3
Interfaces	11.8
Specimen Pickup	6.4
Site Visit	8.4
General	17.1
Software	11.6
Delivery	14.2
Startup	14.4
Evaluation of Cost	11.2
Purchase	13
Installation	14.3
Alternatives	5.4
Records and Evaluations	17
Approvals	9
Priorities	8.2
Backup System	11.7
Documentation of Normal Operations	17.2
Refinement of Functional Requirements	8
Acceptance	16
Enhancements and Updating	18
Project Leader and Project Team	4
Preliminary Vendor Contact	8.3
Project Definition	5
Archival Storage	6.8
Training	15
Allocation	6.5
Unfulfilled Goals	5.3
Laboratory Definition	5.6
Site preparation	14.1
Hardware	11.5
Self-Examination	5.2
Selection of Vendor	12
Evaluation of System Performance	17.4
ICS Codes	35.240.80 - IT applications in health care technology
	Section