What Makes an Effective QAPI Program? Part 5: PI Project - Methodology and Statistics

Once you have established and tracked your objective measures and have determined that an improvement project is in order, you need to make a decision as to which of the available methods and tools that you will use to perform your project. While the tendency will be to rush to begin the project, keep calm and chose the right tool for the right job.

All of the available methods and tools are a means to the same end, namely improvement. However, depending upon the method and tool chosen, different results will be achieved in different timeframes. One consideration in your choice is whether you are trying to achieve improvement in an area of clinical variation or process variation. The over-riding goal is to use the best knowledge available today to improve performance through the elimination of special cause(s) and common cause(s) of variation in processes and then ensure that performance is sustained over time.

While a detailed description of each method is beyond our scope today, some of the various methodologies that exist for process improvement projects include:

• Plan-Do-Study-Act (PDSA/PDCA)

• Model for Improvement (MFI)

• Focus, Analyze, Develop and Execute (FADE)

• Define, Measure, Analyze, Improve, Control (DMAIC)

• Define, Measure, Analyze, Design, Verify (DMADV)

• Identify, Measure, Prioritize, Research, Outline, Validate, Execute (IMPROVE)

• Assess, Plan, Implement, Evaluate (APIE)

• Identify, Determine, Establish, Act (IDEA)

• Failure Mode and Effect Analysis (FMEA)

 

Whichever methodology is chosen, it is important to recognize that they all emphasize continuous improvement and contain similar components for problem solving. First, there is a recognition that an opportunity for improvement exists. The data that you have collected is analyzed and the resultant information facilitates the identification of the causes of deficiency that you observed. During these brainstorming sessions, you need to have the stakeholders involved with the process to guarantee full engagement. This is why it is critical that QAPI is a team effort with everyone participating and contributing to the process. Having a physician champion for your QAPI program as well as for each quality project can be extremely helpful in facilitating team engagement. From this analysis, you identify possible solutions and actions that could potentially solve the problems you observed.

These actions are then tested and if deemed valid, are implemented across your operational processes surrounding the issue at question. Your objective measures are then monitored to first identify improvement and then to assess whether or not the implemented changes have become sustainable. It is recommended to consider four cycles of assessment showing continued improvements as evidence of entrenched sustainability before retiring a quality improvement project. Once retired, it is advisable to continue to monitor the issue on your dashboard to ensure that the improvement continues to be sustained.

Regardless of which method is chosen, you will develop a project charter that lays the groundwork for why and how the project will be conducted. This begins with identifying what the specific purpose or goal is as well as how did you arrive at identifying this issue as requiring a process improvement intervention. Finally, identify what your proposed outcomes or desired results are. Remember, you cannot tackle a problem if you cannot identify it as such.

Next, identify what your plan is to achieve the result. Who will do what and by what deadline. This may be a multi-step process depending upon what the desired goals are. For example, if one is redesigning your pre-transplant evaluation process, there are multiple steps that occur and each may be a source of variation that needs to be addressed.

Finally, identify what metrics and benchmarks will be used to quantify and ensure success of your implemented changes. Depending upon the project, there may be additional steps that are taken after the initial intervention to achieve the desired result. This is particularly true when dealing with projects that address process variation such as transplant candidate evaluation as mentioned above. Remember that these can be very data driven projects and automated data entry and management can improve your productivity and efficiencies. [Process Improvement]

Once you have chosen your methodology, how you analyze your data, or what statistical tools you use is the next consideration. While most statistical tools are not difficult to use or understand, statistical analysis frequently feels daunting. One recommendation is to have a biostatistician available that your program utilizes on an as needed basis to assist with this analysis. There are however, seven Basic Tools of Quality that describe a set of graphical techniques that can be most helpful in addressing quality issues and used within your methodology. These tools require little formal training in statistics and can be employed in most quality related situations. While a full discussion of these techniques is beyond the scope of this blog, these techniques which can be effectively applied to your QAPI programs are a Check Sheet, Flowchart, Histogram, Pareto Chart, Scatter Diagram, Fishbone Diagram, and Control Chart.

In our next blog, we will discuss a few more issues in designing a QAPI plan and provide a real-world example application of these principles.


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.