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ASTM International - ASTM E792-95e1

Standard Guide for Selection of a Clinical Laboratory Information Management System

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Organization: ASTM International
Publication Date: 10 January 2002
Status: inactive
Page Count: 33
ICS Code (IT applications in health care technology): 35.240.80
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:

Section
Project Leader and Project Team4
Project Definition5
General5.1
Self-Examination5.2
Unfulfilled Goals5.3
Alternatives5.4
Selection of Option5.5
Laboratory Definition5.6
Functional Requirements6
General6.1
Admission-Discharge-Transfer6.2
Test Ordering6.3
Specimen Pickup6.4
Allocation6.5
Test Performance6.6
Reports6.7
Archival Storage6.8
Vendor Survey7
Refinement of Functional Requirements8
General8.1
Priorities8.2
Preliminary Vendor Contact8.3
Site Visit8.4
Approvals9
Requests for Proposals10
Evaluation of Vendor Proposals11
General11.1
Evaluation of Cost11.2
Warranty11.3
Maintenance11.4
Hardware11.5
Software11.6
Backup System11.7
Interfaces11.8
Training11.9
Acceptance11.10
Evaluation of Vendors11.11
Selection of Vendor12
Purchase13
Installation14
Site preparation14.1
Delivery14.2
Installation14.3
Startup14.4
Training15
Acceptance16
Records and Evaluations17
General17.1
Documentation of Normal Operations17.2
Documentation of Maintenance17.3
Evaluation of System Performance17.4
Enhancements and Updating18

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.

Document History

ASTM E792-95e1
January 10, 2002
Standard Guide for Selection of a Clinical Laboratory Information Management System
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...
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