IMPROVING CRS PERFORMANCE THROUGH APPLICATION OF LEAN/6 SIGMA

  1. Rationale – the science of operations.

The “clinical research enterprise” faces 2 simultaneous and daunting challenges. It has to both contribute to filling the innovation gap in healthcare while at the same re-engineer itself to become more efficient & integrated across all scientific and social disciplines involved along the translation continuum. It is very much like trying to modify an aircraft while flying in it. Lean/6 sigma is one methodology among many others that can help deliver on this dual challenge. Indeed, this “science of operations”is grounded in robust data analysis to relentlessly reduce waste and variability. It also relies heavily on team-work and open lines of communication between functions, which is a conditioning factor for innovation. Since 2000 it has been increasingly used in hospital settings, with sometimes spectacular results on cost and quality of care delivered (see1for references on improvement on mortality rates and waiting times for instance).It is now being tested in a translational setting2. Liu (2006)describes an application of Six Sigma methods to achieve a reduction of 70% in cycle time for entry of case record forms in a phase III clinical trial, while maintaining a statistically acceptable error rate requirement3. Lean techniques have also been applied to streamline the drug discovery process in the preclinical phase of research.

The goal of this project is to demonstrate the potential of lean/6 sigma to a wide UCSF audience by applying it to the entire CRS program to improve its overall performance. CRS is indeed ideally located at the intersection of clinical and research care. It therefore provides an ideal laboratory to investigate how lean/6 sigma can help theclinical research enterprise transform from an “End-to-End” perspective.

  1. Plan

The project will be implemented following a typical lean/6 sigma structure over a 12 months period:

  1. Define: Map all CRS core services and enabling admin processes using appropriate mapping tools (including Value Stream Map) to identify what activites are done by who and when, and relevant metrics in Cost (nursing costs, operations costs…), Quality(error, wastes…) and Time (duration of activities..) categories.
  2. Measure:collect metrics data using automated or manual solutions (shadowing operations for short periods of time as needed)
  3. Analyze: Identify causes of waste and variations from protocol to protocol in all core services and admin processes. Brainstorm solutions to reduce waste and variablity and define “future state”.
  4. Improve: prioritize and implement highest rewards for lowest complexity solutions.
  5. Control:measure the effectiveness of implemented solutions.
  6. Criteria and metrics for success

Anticipated success for this project is to reduce the following factorsby 5% (in average):

  1. The overall duration to prepare the for the implementation of a protocol
  2. The total labor costspent by CRS to prepare for the implementation of a protocol

We should also expect an increased satisfaction from PIs on the quality of services delivered and increased satisfaction of CRS employees on the job.

  1. Approximate cost and very brief justification ($10k-max $100k)

The anticipated cost of this project is $81,000 to support 1) an Operational Excellenceanalyst/program manager at ~ 40% of her/his effort, and 2) 7 CRS collaborators from core services and admin processes at 2.3% of their time

  1. Collaborators

From PET: OE Analyst to be hired, and from CRS: Eunice Stephens (ops manager), Wendy Staub (sample processing lab manager), Cewin Chao (Bionutrition Director), Kathy Mulligan (Metabolics director), Danusia Filipowski (Clinical Coordinator Core Dir), Nariman Nasser (Participant Recruitment Core Dir), Deanna Sheeley (Research Nursing Core Dir).

APPENDIX

  1. Example of lean/6 sigma results in hospital settings:
  2. St. Joseph’s Hospital changed the ER patient flow, allowing the hospital to treat at least 10,000 more patients annually. –Tampa Bay Business Journal
  3. The Pittsburgh Regional Healthcare Initiative cut the amount of reported central line-associated bloodstream infections by more than 50%. The rate per 1,000 line days (the measure hospitals use) plummeted from 4.2 to 1.9. –ASQ.org (American Society for Quality)
  4. H. Lee Moffitt Cancer Center and Research Institute is expected to increase procedural volume by 12%, which will add nearly $8 million annually in incremental margin. –Tampa Bay Business Journal
  5. A large metropolitan hospital system reduced inpatient transfers by 75% and has $2 million annual cost savings. –iSixSigma.com
  6. A top-five hospital system usedLean Six Sigma to redesign its transplant unit and as a result improved patient satisfaction by 50% within three months; the cost of care was reduced by 15%. –Quality Digest
  7. St. Vincent Indianapolis Hospital made a 78% cut in the number of steps emergency department nurses take to get supplies. –USA Today
  8. A major hospital in the United States was able to reduce inpatient mortality rates by 47.8%. –iSixSigma.com
  9. North Mississippi Medical Center reduced the number of prescription errors in discharge documents by 50%. –ASQ.org(American Society for Quality)
  10. The Mayo Clinic’s Rochester Transplant Center reduced the cycle time from when a new patient made initial contact to setting up an appointment from 45 days to 3 days. –iSixSigma.com
  11. The Applicability of Lean and Six Sigma Techniques to Clinical and Translational Research, Sharon A. Schweikhart, Ph.D. and Allard E Dembe, Sc.D.The Ohio State University, College of Public Health, Center for Clinical and Translational Science, Center for Health Outcomes, Policy, and Evaluation Studies
  12. Lui EW. Clinical research: the Six Sigma way. J Assn Lab Automat. 2006;11(1):42–49.