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Applying Lean Sigma Solutions to Mistake-Proof the Chemotherapy Preparation Process

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Background: Errors related to high-alert medications, such as chemotherapeutic agents, have resulted in serious adverse events. A fast-paced application of Lean Sigma methodology was used to safeguard the chemotherapy preparation process against errors and increase compliance with United States Pharmacopeia 797 (USP 797) regulations.

Workshop Structure and Process: On Days 1 and 2 of a Lean Sigma workshop, frontline staff studied the chemotherapy preparation process. During Days 2 and 3, in terventions were developed and implementation was started.

Findings and Interventions: The workshop participants were satisfied with the speed at which improvements were put to place using the structured workshop format. The multiple opportunities for error identified related to the chemotherapy preparation process, workspace layout, distractions, increased movement around ventilated hood areas, and variation in medication processing and labeling procedures. Mistake-proofing interventions were then introduced via workspace redesign, process redesign, and development of standard operating procedures for pharmacy staff. Interventions were easy to implement and sustainable. Reported medication errors reaching patients and requiring monitoring decreased, whereas the number of reported near misses increased, suggesting improvement in identifying errors before reaching the patients.

Discussion: Application of Lean Sigma solutions enabled the development of a series of relatively inexpensive and easy to implement mistake-proofing interventions that reduce the likelihood of chemotherapy preparation errors and increase compliance with USP 797 regulations. The findings and interventions are generalizable and can inform mistake-proofing interventions in all types of pharmacies.

Document Type: Research Article

Publication date: February 1, 2010

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  • Published monthly, The Joint Commission Journal on Quality and Patient Safety is a peer-reviewed publication dedicated to providing health professionals with the information they need to promote the quality and safety of health care. The Joint Commission Journal on Quality and Patient Safety invites original manuscripts on the development, adaptation, and/or implementation of innovative thinking, strategies, and practices in improving quality and safety in health care. Case studies, program or project reports, reports of new methodologies or new applications of methodologies, research studies on the effectiveness of improvement interventions, and commentaries on issues and practices are all considered.

    David W. Baker, MD, MPH, FACP, executive vice president for the Division of Healthcare Quality Evaluation at The Joint Commission, is the inaugural editor-in-chief of The Joint Commission Journal on Quality and Patient Safety.

    Also known as Joint Commission Journal on Quality Improvement and Joint Commission Journal on Quality and Safety
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