Description

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.