CTSI Annual Pilot Awards to Improve the Conduct of Research

An Open Proposal Opportunity

Improving CRS performance through application of Lean/6 sigma

Proposal Status: 

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).



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.



Overall, I believe the systematic and analytical approaches used in Lean/6 Sigma can definitely be useful in improving CRS overall performance. I just had questions about your metric for success. First, I wasn’t quite clear what #1 is referring to. However, I think your case will be stronger if instead of 5%, you gave numbers (e.g., actually time saved/year (in #1) and dollars saved/year (in #2)). In addition, giving the PIs and CRS employees a survey before and after the analysis would also be a stronger gauge of staff satisfaction. Good luck!!

Thanks for the comments and great points! Metric # 1 refers to the duration between the initial request to CRS by a PI to implement a protocol, and the start of the implementation of such protocol. In essence this is the duration to prepare for the implementation of the protocol. However a more accurate definition is needed, for both metrics. Precise metrics definition and a robust data collection plan are indeed a central part of early phases of a 6 sigma project ("Define" and "Measure"). At the end of these phases we may actually conclude that other performance metrics should be chosen. The "%" is a starting point, but I fully agree: we will need to translate any achieved improvement into time and $ saved. Thanks for the contribution.

This is a great idea, but I think the scope of work planned for one year is far too broad unless you plan to add a significant number of new staff to this project. Even if you add new staff, the staff of the CRS will need to be heavily involved to educate the lean consultants on CRS procedures and regulations. I think it would be more feasible to begin with a defined segment of CRS activities. I believe such a "pilot study" will give you a much better idea of the scope of the full project, and provide a lot of information to help you and the CRS staff move forward efficiently.

The timing of this proposed project is perfect for CRS as we implement a new business model and a functionally-based organizational structure. A first exploration of the possibility for improvement has been launched with the Sample Processing Core Services lab. The lab manager, Wendy Staub, and her lab staff have participated in a workshop to identify areas for improved efficiency and elimination of waste. The group was actively engaged in the process and this first step has identified areas for improvement that can be incorporated into the Balanced Scorecard and can help with the development of more impactful metrics for the core service. CRS core managers have each had a first meeting and discussion about the challenges they face in delivering core services. These early meetings identified key areas for improvement. The more focused work with their teams that would be supported by this proposal will engage the managers and staff in identifying specific strategies for implementing and measuring improvements. As administrative procedures are put in place to support the new financial model, this process will allow us to look at the continuum of services and activities from the perspective of our investigators and sponsors, incorporate the feedback from the staff doing the work, and ensure that our new processes are as efficient as possible.

We have already done a pilot of improved efficiency though not with these proven strategies. This CRS service is the perfect place to start and this is the absolute ideal time to do this - a time when we have fresh and talented new leadership in the CRS and in PET and when we need to markedly improve our efficiency as the demand for our services continues to ramp up. The "costs" of not doing this include (1) a significant delay in reaching CRS's entire cost recovery strategies and ultimately the fiscal viability and sustainability of the CTSI itself, and (2)a less than positive message to the leadership and staf of both CRS and PET.

Lots of potential here. I will echo Deborahs scope point (ie. focus the proposal on a particular process or set of processes), and I agree with Dezba that the metrics don't feel useful as a '%' reduction, instead $s saved or FTEs reduced feels more useful in assessing the return on the investment. Since you describe a 70% reduction in time to process cases in the paper you reference, a 5% decrease feels a bit like a let down - you just need to align the scope of your project with expected reduction in the short term, and clarify how that is but one step to a broader effort that then might have greater benefits down the line.

This is an interesting approach to increase productivity and reduce cost. A positive outcome and subsequent wider adoption would strengthen the clinical research infrastructure.

This is an area of great interest to me as my degree is in IEOR which predates and is the origin for many of the Six Sigma concepts. I think it is a great idea and I would gladly lend my support to it. I would also suggest contacting the UC Berkeley IEOR department to see if they would have any interest in getting involved. I suspect they would be, as UCB in general has been very supportive of our activities here. I think that this collaboration would augment the approach quite well as both sides bring expertise unique to each entity.

Jeff - thanks for your interest and I'd be happy to check with UCB IEOR! Industrial Engineering best practices could indeed be very helpful in many areas, such as patient and protocol implementation scheduling for instance. I look forward to the exchange!

Deborah and Mini - thanks for your comments. Deborah - I updated the proposal to reflect the fact that the D, M and A phases should be done holistically, but that the scope of the I and C phase will be focused on select areas to be mindful of the limited resources we have. Also - by design a lean/6 sigma "Improve" phase does include a piloting step prior to full scale implementation. So your concern about pilots would be adressed. Mini - the main rationale for selecting a % reduction target is to offset the 2012 budget reduction. I modified the proposal to make it clearer that the goal is to reduce program costs by 5% to offset the 5% 2012 budget reduction. This translates into ~$750k of savings. We could set more aggressive targets but we may then need more resources. I removed the "time" target for now. Another success measure would be to target a certain amount of revenue increase, which in the end is the ultimate strategy of CRS. We could indeed consider that CRS is transforming into a self sustaining business...With the implementation of the recharge model we should get a better idea of the needed revenue increase to balance the budget out!

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