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  • ASTM
    E792-95e1 Standard Guide for Selection of a Clinical Laboratory Information Management System
    Edition: 1995
    $134.78
    Unlimited Users per year

Description of ASTM-E792 1995

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:

Section
Project Leader and Project Team 4
Project Definition 5
General 5.1
Self-Examination 5.2
Unfulfilled Goals 5.3
Alternatives 5.4
Selection of Option 5.5
Laboratory Definition 5.6
Functional Requirements 6
General 6.1
Admission-Discharge-Transfer 6.2
Test Ordering 6.3
Specimen Pickup 6.4
Allocation 6.5
Test Performance 6.6
Reports 6.7
Archival Storage 6.8
Vendor Survey 7
Refinement of Functional Requirements 8
General 8.1
Priorities 8.2
Preliminary Vendor Contact 8.3
Site Visit 8.4
Approvals 9
Requests for Proposals 10
Evaluation of Vendor Proposals 11
General 11.1
Evaluation of Cost 11.2
Warranty 11.3
Maintenance 11.4
Hardware 11.5
Software 11.6
Backup System 11.7
Interfaces 11.8
Training 11.9
Acceptance 11.10
Evaluation of Vendors 11.11
Selection of Vendor 12
Purchase 13
Installation 14
Site preparation 14.1
Delivery 14.2
Installation 14.3
Startup 14.4
Training 15
Acceptance 16
Records and Evaluations 17
General 17.1
Documentation of Normal Operations 17.2
Documentation of Maintenance 17.3
Evaluation of System Performance 17.4
Enhancements and Updating 18

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

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