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 (see¹ for references on improvement on mortality rates and waiting times).  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 Clinical Research Services (CRS) program to effectively manage its overall performance, and improve Quality and Costs in areas where it is needed. 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 the clinical research enterprise transform from an “End-to-End” perspective.

2.     Plan & Scope.

The project will encompass the overall CRS program and will be executed by following a typical lean/6 sigma structure or DMAIC (Define, Measure, Analyze, Improve, Control) over a 12-month period.  The project scope includes an initial End-to-End process map and gap analysis of all services provided by CRS to further highlight priority areas based on feasibility and ROI. The End-to-End process map will start with the initial PI request for CRS services and will end with their successful delivery.  From the initial assessment, detailed data collection plans, analysis, and solution proposals will be drafted and presented to the appropriate stakeholders to obtain endorsement for the chosen solutions.  Below are the strategies and expected deliverables per DMAIC phase that will be followed to conduct the initial and final assessments across CRS:

• Define Phase (2 Months):
  • Intent: Define the problem statement and associated quantitative success criteria (i.e. Cost, Time, Speed) within the defined scope via an End-to-End process map.
  • Deliverables:  Project Charter, Voice of the Customer (VOC), High-level Process Maps (i.e. SIPOC), Communication Plan, and Project Plan.
• Measure Phase (2 Months):
  • Intent:  Measure current performance on the previously determined success criteria across CRS.
  • Deliverables:  Data Collection Plan, Measurement System Analysis (MSA) – As needed
• Analyze Phase (2 Months):
  • Intent: Identify potential root causes by conducting correlation and root cause analyses.
  • Deliverables:  Stratification, Ishikawa Diagrams (As Needed), Correlation Analysis (As Needed)
• Improve Phase (4 Months):
  • Intent:  Present proposed solutions for identified gaps to the appropriate stakeholders.  Based on the endorsed options and available resources, implement chosen solutions. 
  • Deliverables:  Gap Analysis, Proposed solutions and prioritization criteria (i.e. Time, Resources)
• Control Phase (2 Months):
  • Intent:  Ensure the sustainment and effectiveness of the solutions implemented
  • Deliverables: Control Plan, Service Level Agreements (SLA), Training (as needed), Change in Policies/Operation Procedures (as needed). 

3.     Criteria and metrics for success

Anticipated success for this project is to generate improvements that allow CRS to decrease its total program costs by 5% (~ $750k). The rationale for this goal is to at least offset the 5% budget cut from the 2012 budget. Another success goal could be to align the improvement efforts with the long-term strategy of CRS, which is to increase its revenues. No target can be reasonably set on revenues at this moment but could by the end of the Measure phase.

4.    Total Budget: $73,980

The anticipated cost of this project is $73,980 to support a Project Lead at ~ 58% of her/his effort 

5.     Collaborators

From PET: Adel Elsayed, 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:

• 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 
• 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) 
• 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 
• A large metropolitan hospital system reduced inpatient transfers by 75% and has $2 million annual cost savings. – iSixSigma.com 
• A top-five hospital system used Lean 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
• St. Vincent Indianapolis Hospital made a 78% cut in the number of steps emergency department nurses take to get supplies. – USA Today
• A major hospital in the United States was able to reduce inpatient mortality rates by 47.8%. – iSixSigma.com
• North Mississippi Medical Center reduced the number of prescription errors in discharge documents by 50%. – ASQ.org(American Society for Quality)
• 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

2.     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
3.     Lui EW. Clinical research: the Six Sigma way. J Assn Lab Automat. 2006;11(1):42–49.