What Makes an Effective QAPI Program? Part 4: Transitioning to Process Improvement Projects

Our previous blogs on Quality Assessment and Process Improvement (QAPI) in this series have focused on designing objective measures and using those to monitor key aspects of our transplant programs. Today, we want to discuss what to do with those measures and how to translate them into successful process improvement projects. 

Before we begin, I wanted to put to rest one common misconception; namely that the Center for Medicare and Medicaid Services (CMS) requires programs to have an improvement project for every objective measure.  CMS does not require each objective measure to have a process improvement project associated with it.  You should have a project for each phase of transplant and your living donor program that reflects both a process and outcome measure.  However, it is appropriate for you to track your improvement projects with objective measures. 

Code of Federal Regulations §482.96(a) requires transplant programs to take actions that result in performance improvements and track performance to ensure that those improvements are sustained.  The specific areas that will require attention will vary depending upon organ type and the documentation of these efforts should be consistent with the program’s defined performance improvement model or methodology.  As mentioned in earlier blogs, the bi-directional reporting of these activities between staff, the transplant program, and hospital leaders promotes a culture of continuous learning and improvement must be evident to reviewers of the program. 

If one considers the acronym QAPI, the objective measures comprise the QA (quality assessment); the systematic act of appraisal or the process of gathering and discussing information from multiple sources in order to better understand a situation. The PI, or process improvement, portion involves the concept of measuring the output of a particular process or procedure, then modifying the process or procedure to increase output, increase efficiency, or increase the effectiveness of the process or procedure.

We have spent a lot of time speaking about objective measures and how to design them.  Objective measures allow us to define, collect, analyze and utilize data.  This discovery exercise allows us to identify or define the problem and map the process by which we shall try to fix it.  As we implement change, we continue to monitor and evaluate the changes that are made, using our objective measures to identify variation or deviation from the newly expected results.  Once we see no variation through a series of usually four continuous cycles, the change can be accepted as having been successfully implemented.

Performance improvement projects may have their genesis in one of several places.  The first, which is fairly obvious, is that they may arise from the objective measures that we have been talking about, specifically when the measures exhibit negative trends away from desired outcomes or reveal an undesired measurement of performance. Another example of objective measures leading to a process improvement project is when a specific adverse event incidence rises against an expected outcome.  A second source of process improvement projects are those areas that are more likely to exhibit sub-standard outcomes and are identifiable as being high risk, high or low volume or problem prone areas.  These may be identified as a result of staff recommendations from a gap analysis or risk assessment for example.  Finally, process improvement projects may be structured around the planned re-design of a patient care process as a method of assessing the successfulness of implementation.  These projects may be identified following a review of policies and procedures or after a program review that initiates a redesign of patient care processes.

We have stressed the importance of not being a “DRIP” (data rich and information poor”) program previously.  In recent QAPI surveys, some of the deficiencies that CMS has identified include:

  1. Did not address complete continuous Performance Improvement process.
  2. No evidence of entire scope of quality continuum identified problems, aggregated data, analysis, appropriate action taken, improvements made, or evidence of sustained compliance.
  3. No evidence of actions to improve on 26 of 28 measures.
  4. QAPI plan did not include any stage related to control or monitoring of actions taken that led to sustainable improvements.
  5. No evidence the last step of QAPI process to monitor and collect data was done.
  6. QAPI plan did not address a QAPI process that addressed how improvement was evaluated or sustained.
  7. QAPI plan did not include mechanism to ensure problems were promptly identified or how long term measures were implemented and evaluated to ensure continuous compliance.

As you can see, QAPI is not just data collection.  The ideal process improvement project in health care is a modification of a current process by making systematic changes to care practices and health systems to improve the quality, efficiency, and effectiveness of patient care. Improving a system by intentional change in this manner is termed a “re-design.” Re-designed systems have the potential to have broad impact to improve the way things work and on the end results. Some models for re-design that can be utilized in health care include: Six Sigma, Toyota Production System (Lean), and Quality by Design.

Our next blog will look at some of the methods and statistical tools that can be used in your QAPI program. 


About the Author: Dr. John Daller, MD, PhD, FACS

As a former Director of several transplant programs, Dr. Daller has expertise in all aspects of transplant program management, as well as hospital program development including clinical, regulatory, business and administrative leadership via his company Strategic Illuminations. He consults in the area of medical legal review, due diligence and scientific evaluations, as well as utilization review via Daller Consulting. He is also Chief Medical Officer of Concordia Valsource, LLC which provides consultative services to developing biopharmaceutical companies and to Venture Capital groups investing in the health and life sciences. Previously, Dr. Daller was Vice President for Medical Programs in the Transplant Business Unit of Genzyme Corporation.