Development and implementation of an automatic system for verification, validation and delivery of laboratory test results

Clin Chem Lab Med. 2009;47(11):1355-60. doi: 10.1515/CCLM.2009.316.


Background: The verification/validation of laboratory test results is one of the most critical aspects of the total testing process, which may produce conflicts between competencies and duties at the point of professional crossroads. This process has centered for decades on the human component, with positive effects as well as potential adverse consequences (postanalytical errors). Manual validation of data is a time-consuming activity, is inherently subjective and arbitrary, and requires the constant presence of postgraduate physicians or biologists within the laboratory with adverse economical and organizational impacts. To overcome these inherent limitations, we have developed and implemented in our stat department an automatic system for verification, validation and delivery of laboratory results.

Methods: The procedure is based on automatic validation of test results by an expert system, coupled with remote wireless connection, which allows the laboratory professional "on call" to access, visualize, analyze, validate and deliver alert values (suspect, erroneous or critical) using a small laptop. This system also provides five phases where preanalytical and analytical errors can be identified and handled.

Results and conclusions: Six months following implementation of this innovative system, which can be customized to facilitate a wide variety of laboratory workflow models, the reporting efficiency of our stat laboratory has greatly improved, reducing manual data entry, and increasing the timeliness and utility of test results.

MeSH terms

  • Automation
  • Clinical Laboratory Information Systems / instrumentation
  • Clinical Laboratory Information Systems / standards*
  • Clinical Laboratory Techniques / instrumentation
  • Clinical Laboratory Techniques / methods
  • Clinical Laboratory Techniques / standards*
  • Diagnostic Tests, Routine / instrumentation
  • Diagnostic Tests, Routine / methods
  • Diagnostic Tests, Routine / standards*
  • Humans
  • Quality Control
  • Reproducibility of Results
  • Research Design