ASTM E792-02
Standard Guide for Selection of a Clinical Laboratory Information Management System

Standard No.
ASTM E792-02
Release Date
2002
Published By
American Society for Testing and Materials (ASTM)
Status
Latest
ASTM E792-02
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 18212;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
General5.1
Self-Examination 5.2
Unfulfilled Goals 5.3
Alternatives 5.4
Selection of Option5.5
Laboratory Definition 5.6
Functional Requirements 6
General 6.1
Admission-Discharge-Transfer6.2
Test Ordering 6.3
Specimen Pickup6.4
Allocation6.5
Test Performance 6.6
Reports6.7
Archival Storage 6.8
Vendor Survey 7
Refinement of Functional Requirements8
General 8.1
Priorities 8.2
Preliminary Vendor Contact 8.3
Site Visit 8.4
Approvals 9
Requests for Proposals10
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
Acceptance11.10
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
Training15
Acceptance 16
Records and Evaluations 17
General17.1
D......

ASTM E792-02 Referenced Document

  • ASTM E1013 
  • ASTM E1029 Standard Guide for Documentation of Clinical Laboratory Computer Systems
  • ASTM E1113 
  • ASTM E1238 Standard Specification for Transferring Clinical Observations Between Independent Computer Systems
  • ASTM E1239 Standard Practice for Description of Reservation/Registration-Admission, Discharge, Transfer (R-ADT) Systems for Electronic Health Record (EHR) Systems *， 2024-04-19 Update
  • ASTM E1246 Standard Practice for Reporting Reliability of Clinical Laboratory Computer Systems
  • ASTM E1340 Standard Guide for Rapid Prototyping of Computerized Systems
  • ASTM E1381 Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
  • ASTM E1384 Standard Guide for Content and Structure of the Electronic Health Record (EHR)
  • ASTM E1394 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems
  • ASTM E1466 Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
  • ASTM E1633 Standard Specification for Coded Values Used in the Electronic Health Record*， 2024-04-19 Update
  • ASTM E1639 Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
  • ASTM E1712 
  • ASTM E1714 Standard Guide for Properties of a Universal Healthcare Identifier (UHID)*， 2024-04-19 Update
  • ASTM E1715 Standard Practice for An Object-Oriented Model for Registration, Admitting, Discharge, and Transfer (RADT) Functions in Computer-Based Patient Record Systems
  • ASTM E2118 Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
  • ASTM E622 
  • ASTM E623 
  • ASTM E625 
  • ASTM E626 
  • ASTM E627 
  • ASTM E730 
  • ASTM E731 
  • ISO 6592 Information processing; Guidelines for the documentation of computer-based application systems
  • ISO 9127 Information processing systems; user documentation and cover information for consumer software packages

ASTM E792-02 history

  • 2002 ASTM E792-02 Standard Guide for Selection of a Clinical Laboratory Information Management System
  • 1995 ASTM E792-95e1 Standard Guide for Selection of a Clinical Laboratory Information Management System
Standard Guide for Selection of a Clinical Laboratory Information Management System


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