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"Our challenge is not to develop more sensitive ways to detect our risks, our errors, our flaws, our variation, our indignities, our fragmentation, our delays, our waste, our insults to the people we say we exist to serve. Our challenge is to have the courage to name clearly and boldly the problems we have."
- Donald Berwick, President and CEO of the Institute for Healthcare Improvement
Understanding your current process is crucial to understanding what works and what requires improvement. There are several methods that can be used to assess your current process and identify problems. The methods described here will help define your current medication reconciliation process and explain how to apply these methodologies to improve medication reconciliation at your organization.
A. Failure mode and effects analysis (FMEA)
A FMEA is a systematic method for identifying, prioritizing, and ultimately preventing product and process problems before they occur. Ideally, FMEAs are conducted in the product design or process development stages before implementation. Conducting a FMEA on existing products and processes may also be beneficial.3
A FMEA is a team effort. The purpose of the FMEA team is to bring a variety of experiences and perspectives to the project so that every step in the process can be fully understood. Including front-line personnel and all disciplines involved in that process to participate in the analysis is essential.
A FMEA team leader needs to be appointed to coordinate the FMEA process. The team leader is responsible for setting up and facilitating team meetings, keeping the team on track during meetings, ensuring the team is progressive towards the completion of the FMEA and ensuring the team has resources available if needed. It is also important to involve all stakeholders in the process from the beginning so they become fully invested in not only defining the problem but making sure the recommended actions by the FMEA team are implemented.
Steps in the FMEA Process:
FMEA Sample Presentations and Tools
The presentation below goes through the evolution of and key goals and definitions used in a FMEA process. This may be a helpful presentation to give when you have an audience that has never been involved in a FMEA and needs to be educated on where FMEA originated and what is involved in a FMEA.
The presentation below describes the application of a FMEA to medication reconciliation. This presentation is an example of how our own organization addressed our current medication reconciliation process upon admission to the hospital using the FMEA methodology.
It is important to understand that every organization will have different FMEA results. An organization's FMEA results may not apply to other organizations; that is why it is important to conduct your own FMEA to get a better understanding of the current medication reconciliation process at your own organization.
Below are some common tools used in collecting data and calculating FMEA results. An example of a summary report is available below to highlight how to present your findings in a way that is easy to interpret.
FMEA Data Collection Form (PDF format)
FMEA Final Report Example (PDF format)
To learn more about failure mode and effects analysis, the references below will be helpful and contain detailed information for conducting a FMEA at your organization.
B. DMAIC: Define, Measure Analyze, Improve, and Control
DMAIC is a step by step approach to process improvement that is grounded in structure, discipline and rigor. The goal of DMAIC is not only to improve the process as defined by your problem statement, but also to maintain the improvements.
Define: The objective of the first phase in DMAIC, Define, is to determine the problem that needs to be solved. This is done through establishing a purpose, scope and goal of the project. The major outputs of this phase are:
Measure: During the Measure phase, one determines how to measure the process, and then collects the data that is required. This phase assesses the current situation, establishes baseline performance and determines the process measures. The major outputs of Measure are:
Analyze: During the Analyze phase one identifies the one to three sources of variation in the process. Analyze phase is the most statistically intensive and requires:
Improve: The goal of Improve is to generate alternatives to the current process, assess the risk of these alternatives, test the alternatives, and then select the best alternative. One must:
Control: In Control (the final phase) one intends to error-proof the new process, create a robust design, and use tools to monitor the process. It is essential during this phase to:
Roles and Responsibilities of DMAIC team members
Executive Sponsor (ES) is the member of senior management who provides overall guidance and accountability for the project. The ES approves the final charter and recommendations, ensures timely implementation, secures any necessary financial support, removes organizational barriers to project success, and makes certain that the project has sustained results.
Project Sponsor (PS) is accountable for the timely and successful implementation of the project. The PS has close contact and meets regularly with the Improvement Leader. The PS helps charter the project, reviews progress, removes project barriers, and measures status. The PS may also be a key decision-maker for approval of final recommendations.
Improvement Leader (IL) is the DMAIC methodology expert and is accountable for using DMAIC to manage the project and complete all deliverables in a timely manner. The IL partners with the Process Owner and engages all project constituents to ensure that project goals are met within the required timeframe and budget. As the project approaches Control, management of the outputs and improvements transitions to the Process Owner.
Process Owner (PO) is accountable for implementing, controlling, and measuring the project outputs and improvements. The PO works side-by-side with the IL and fully understands the project plan, deliverables and goals.
Improvement Team (IT) is comprised of individuals who will make a significant and focused contribution to the timely and successful implementation of the project. The IT, with their intricate knowledge of the problem, contributes ideas and significantly impacts the direction of the project.
Note: It is expected that Improvement Leaders, Process Owners and Improvement Team Members will actively participate in each DMAIC phase, complete various tools utilized for the project, collect data for measurement and conduct analytics as deemed necessary.
Below is a presentation that shows how the DMAIC methodology can be applied to the medication reconciliation process.
C. The Institute for Healthcare Improvement (IHI) Model for Improvement
The Model for Improvement1 is a simple yet powerful tool for accelerating improvement. It is not meant to replace change models that organizations may already be using, but rather to accelerate improvement. This model has been used very successfully by hundreds of health care organizations in many countries to improve many different health care processes and outcomes.
The model has two parts:
The steps included in the Model for Improvement include:
Forming the Team
Including the right people on a process improvement team is critical to a successful improvement effort. Teams vary in size and composition.
Setting Aims - "What are we trying to accomplish?"
Improvement requires setting aims. The aim should be time-specific and measurable; it should also define the specific population of patient that will be affected.
Establishing Measures - "How will we know that a change is an improvement?"
Teams use quantitative measure to determine if a specific change leads to improvement. The IHI states that measurement is a critical part of testing and implementing changes. Measurement for improvement should not be confused with measurement for research as outlined in the table below.
| Measurement for Research | Measurement for Process Improvement | |
| Purpose | To discover new knowledge | To bring new knowledge into daily practice |
| Tests | One large "blind" test | Many sequential, observable tests |
| Biases | Control for as many biases as possible | Stabilize the biases from test to test |
| Data | Gather as much data as possible, "just in case" | Gather "just enough" data to learn and complete another cycle |
| Duration | Can take long periods of time to obtain results | "Small tests of significant changes accelerates the rate of improvement |
Selecting Change - "What changes can we make that will result in improvement?"
All improvement requires making changes, but not all changes result in improvement. Organizations therefore must identify the changes that are most likely to result in improvement.
Testing Changes
The Plan-DO-Study-Act (PDSA) cycle is shorthand for testing a change in the real work setting - by planning it, trying it, observing the results, and acting on what is learned. This is the scientific method used for action-oriented learning.
IHI PDSA Worksheet for Testing Change (PDF format)
Implementing Changes
After testing a change on a small scale, learning from each test, and refining the change through several PDSA cycles, the team can implement the change on a broader scale - for example, for an entire pilot population or on an entire unit.
Spreading Changes
After successful implementation of a change or package of changes for a pilot population or an entire unit, the team can spread the changes to other parts of the organization or in other organizations.
For more information about the Model for Improvement go to: http://www.apiweb.org/API_home_page.htm
For more information about the Institute for Healthcare Improvement and quality improvement methodologies go to: http://www.ihi.org/IHI/Topics/Improvement/
References:
1. Langley GL, Nolan KM, Nolan TW, Norman CL, Provost LP. The Improvement Guide: A Practical Approach to Enhancing Organizational Performance.
2. The Plan-DO-Study-Act cycle was developed by W. Edwards Deming. Deming WE. The New Economics for Industry, Government, Education.
3. McDermott RE, Mikulak RJ, Beauregard MR. The Basics of FMEA. Portland, OR: Productivity, Inc; 1996.
