title: Applying Lean Sigma solutions to mistake-proof the chemotherapy preparation process.
abstract: 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.
  On Days 1 and 2 of a Lean Sigma workshop, frontline staff studied the chemotherapy preparation process. During Days 2 and 3, interventions were developed and implementation was started.
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Center for Innovation in Quality Patient Care, Johns Hopkins University, Baltimore, USA. habouma1@jhmi.edu
authors.forename: Hanan J
authors.initials: HJ
authors.lastname: Aboumatar
authors.forename: Laura
authors.initials: L
authors.lastname: Winner
authors.forename: Richard
authors.initials: R
authors.lastname: Davis
authors.forename: Aisha
authors.initials: A
authors.lastname: Peterson
authors.forename: Richard
authors.initials: R
authors.lastname: Hill
authors.forename: Susan
authors.initials: S
authors.lastname: Frank
authors.forename: Virna
authors.initials: V
authors.lastname: Almuete
authors.forename: T Vivian
authors.initials: TV
authors.lastname: Leung
authors.forename: Peter
authors.initials: P
authors.lastname: Trovitch
authors.forename: Denise
authors.initials: D
authors.lastname: Farmer
mesh_terms: D000046:Academic Medical Centers; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004339:Drug Compounding / Q000379:methods / Q000592:standards*; D006801:Humans; D007318:Inservice Training; D033183:Interdisciplinary Communication; D008508:Medication Errors / Q000517:prevention & control*; D008510:Medication Systems, Hospital; D009741:Nursing Staff, Hospital; D019982:Organizational Case Studies; D010595:Pharmacists; D010607:Pharmacy Service, Hospital
chemical_list: D000970:Antineoplastic Agents