The improvements in remote communication have allowed laboratories to market their services to physicians’ offices, with one of the key components being access to a patient’s test results throughout the continuum of care by means of terminals, handheld devices, or printers located in the physician’s office or home. Many physicians have access to both the laboratory test results and to other pertinent clinical information through their personal PCs.
In response to what was perceived as neglect (i.e., improper monitoring, maintenance, and repair protocols), inspection has become part of the laboratory information system operation. Voluntary accrediting agencies (e.g., College of American Pathologists [CAP], American Association of Blood Banks [AABB]), and federal regulatory agencies, like the Food and Drug Administration (FDA), and others have begun focusing attention on laboratory information systems to ensure that they are properly tested and monitored.
The CAP has included questions about laboratory information systems on its accreditation checklist for many years. In 1989, the AABB updated its guidelines to include more stringent documentation, testing, and standard operating procedures for blood bank computer systems. Since 1987, the FDA has made the inspection of the computer system a routine part of every blood bank inspection.
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Through the Clinical Laboratory Improvement Act (CLIA) regulations, laboratory information systems are part of regular laboratory inspections.6 clearly, these agencies are requiring proof of validation of information systems used in clinical laboratories
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The administrative laboratory director oversees both bench technologists and the computer support group as they generate, process, store, and transmit information. In the past, these supervisory responsibilities consisted primarily of selecting, purchasing, and deploying laboratory information systems, analytical instruments, and test methods.
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In the future, the administrative laboratory director will work more closely with the daily information management component of the laboratory and the healthcare delivery system. Some of the elements of this collaboration are the following.
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