Automation and Process Re-engineering Work Together to Achieve Six Sigma Quality: A 27-Year History of Continuous Improvement.

BACKGROUND: In most clinical laboratories, examination quality is considered excellent, whereas pre-/postexamination quality is an area for focused improvement. In our organization, 1 pre-/postexamination quality metric, namely, lost specimens, as tracked continuously for 27 years, has demonstrated steady improvement. During this period, many of our processes transitioned to highly automated effectors. Concurrently, we implemented behavioral controls and reengineered error-prone processes. We believe that this bilateral approach has conclusively lowered our lost specimen rates.

METHODS: Using data spanning 27 years, we plotted the correlation between lost specimens and the implementation dates for 8 major phases of automation, as well as 19 process improvements and engineering controls.

RESULTS: The lost specimen rate decreased nearly 100-fold. In Six Sigma terms, the 12 month moving average for lost specimens currently hovers at approximately 5.94 sigma, with 11 months at or better than 6 sigma. Although the combination of implementation of process improvements, engineering controls, and automation contributed to the reduction, automation was the most significant contributor.

CONCLUSIONS: The custom automation in use by our laboratory has led to improved pre-/postexamination quality. Although this automation may not be possible for all laboratories, our description of 19 behavior and engineering controls may be useful to others seeking to design high quality pre-/postexamination processes.