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Historical management activities such as quality control (QC) and quality assurance (QA) have not prevented medical errors or patient safety problems related to the laboratory. Reports of laboratory quality assurance activities provide evidence of the need for significant improvement in the total laboratory path of workflow when measured on the Six Sigma scale. The old paradigm has been: people are the cause of medical errors and the solution is to name, blame, and shame them. This bias is being replaced by a new awareness that system failures cause medical errors and that a systematic process management approach to improving patient safety can prevent these hazards.

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