Область применения

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:

SectionProject Leader and Project Team 4Project Definition 5General5.1Self-Examination 5.2Unfulfilled Goals 5.3Alternatives 5.4Selection of Option5.5Laboratory Definition 5.6Functional Requirements 6General 6.1Admission-Discharge-Transfer6.2Test Ordering 6.3Specimen Pickup6.4Allocation6.5Test Performance 6.6Reports6.7Archival Storage 6.8Vendor Survey 7Refinement of Functional Requirements8General 8.1Priorities 8.2Preliminary Vendor Contact 8.3Site Visit 8.4Approvals 9Requests for Proposals10Evaluation of Vendor Proposals 11General 11.1Evaluation of Cost 11.2Warranty 11.3Maintenance 11.4Hardware 11.5Software 11.6Backup System 11.7Interfaces 11.8Training 11.9Acceptance11.10Evaluation of Vendors 11.11Selection of Vendor 12Purchase 13Installation 14Site preparation 14.1Delivery 14.2Installation 14.3Startup 14.4Training15Acceptance 16Records and Evaluations 17General17.1Documentation of Normal Operations17.2Documentation of Maintenance17.3Evaluation of System Performance17.4Enhancements 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.