The laboratory information system as a medical device: inspection and accreditation issues.
Laboratory information systems (LISs) allow laboratories to produce more reliable results than can be provided with manual systems--as long as attention has been given to system testing, monitoring, maintenance, and repair of the LIS. Regulatory and voluntary accrediting agencies have recently begun reminding us of what we should have been doing all along--ensuring that our computerized systems are operating properly. Initial regulatory efforts caused some misunderstandings and confusion, but a more balanced approach is now being taken. The safety and reliability of software can be improved, at reasonable cost, by paying attention to standards for requirements definition, initial testing, monitoring, change control, and overall documentation. We must continue using and improving our automated systems, rather than abandoning automation in favor of error-prone manual systems.
Aller
R D
RD
Long Beach Memorial Medical Center, CA.
D000068:Accreditation / Q000458:organization & administration*; D001771:Blood Banks / Q000331:legislation & jurisprudence / Q000592:standards*; D002984:Clinical Laboratory Information Systems / Q000331:legislation & jurisprudence* / Q000592:standards; D004282:Documentation / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D007221:Industry / Q000331:legislation & jurisprudence; D012986:Software Validation; D014481:United States; D014486:United States Food and Drug Administration