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A Six Sigma approach to the rate and clinical effect of registration errors in a laboratory


Background Laboratory errors made during the pre-analytical phase can have an impact on clinical care. Quality management tools such as Six Sigma may help improve error rates.

Aim To use elements of a Six Sigma model to establish the error rate of test registration onto the laboratory information system (LIS), and to deduce the potential clinical impact of these errors.

Methods In this retrospective study, test request forms were compared with the tests registered onto the LIS, and all errors were noted before being rectified. The error rate was calculated. The corresponding patient records were then examined to determine the actual outcome, and to deduce the potential clinical impact of the registration errors.

Results Of the 47 543 tests requested, 72 errors were noted, resulting in an error rate of 0.151%, equating to a sigma score of 4.46. The patient records reviewed indicated that these errors could, in various ways, have impacted on clinical care.

Conclusion This study highlights the clinical effect of errors made during the pre-analytical phase of the laboratory testing process. Reduction of errors may be achieved through implementation of a Six Sigma programme.

  • Pre-analytical
  • laboratory errors
  • six sigma
  • clinical impact
  • audit
  • laboratory management

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