Quality Improvement & Patient Safety Hot Topics

Jordan S. Peck, PhD

Vice President of Physician Practice Operations

Southern Maine Health Care

Learning Objectives:

• Describe common challenges associated with performance improvement work
• Recognize applications of a few improvement tools in appropriate context

When you visit the MaineHealth Center for Performance Improvement (CPI) website, one of the links is “Tools and Trainings.”[1] Whenever I see this link, a montage of eye rolls goes through my head. Generally I have received positive responses to a disciplined quality/performance improvement (QI/PI) project approach and to the corresponding tools, but I have also heard:

• “Why can’t we ‘just do it!”
• “I don’t like all of this data collection, my team prefers to just ‘PDSA’…”
• “Whatever, I am sure the charter is fine”… 6 months later… “why we are working on this?”
• “We don’t need a Lean person, I can throw a bunch of post it notes on the wall!”
• “Lean Black Belt… are you going to kick our patients?”
• “There are too many templates to fill out, I don’t have time for this!”
• “Why do we need a whole process just to get people to do their jobs?”

Figure 1 is a list of Lean tools created by the Lean EdNet[2]

Modern Lean literature talks about Lean Daily Management Systems (coined “Operational Excellence at MaineHealth) and culture change as opposed to tools.[1] However, even these high level initiatives offer a healthy dose of tools  such as Letter Charts, Run Charts, Pareto Charts, Action Plan Documents, Strategic Goals driver documents, etc.

Why do all of these tools exist? Why can’t we “just do it?” When leading (QI/PI) projects it is difficult to find the balance between being disciplined and getting overwhelmed with tools. When faced with this problem, I keep the following principles in mind:

1. We don’t know the real problem: I have always loved the phrase (used by TV doctors), “What SEEMS to be the problem?” The phrase implies that the patient will describe a symptom and let the expert really understand the underlying problem. Similarly, if we initiate a project based on a symptom and without a disciplined approach, we treat the symptoms and not the problem. The benefits of avoiding this are obvious, but we shouldn’t throw the whole QI/PI toolbox at it. Often a 5 Why’s exercise is enough and you don’t need to make a fishbone diagram; or a process map is enough and you don’t need to make a spaghetti diagram.
2. Symptoms are experienced in different ways by each stakeholder: Often you think you know the problem, but the person next to you has experienced it in a totally different way. A fundamental to project success is getting everyone on the same page. Some people use an “A3” document for this; others use actual project management-style charters. Remain aware of many charter tool options and pick a tool that ensures the conversation has happened without overwhelming and unnecessary details.
3. Humans struggle with just ‘getting it done,’ even when they are committed: It is well understood that people struggle with weight, reading that book on our night stand, and with any other New Year’s resolution. But when someone is struggling to achieve a task at work we ask “why they can’t just do their job.” The QI/PI tools are designed to acknowledge that even the most committed person has very real barriers to completing seemingly simple tasks. Like the myriad tools and plans to help people meet their weight loss goals, QI/PI tools, processes, and plans are needed to make it easy to do the right thing. Working in healthcare, I have seen a lot of teams that have identified “just do its” through short conversations, avoiding a deeper project. The problem is that these solutions are often really “just remember its” and rely on a human to figure it out for themselves moving forward. Without a process or method to ensure that an action happens, no real solution has been generated.
4. The Solution isn’t obvious or it would have been fixed already: Even a published best practice is sometimes unsuccessful in a new context. For this reason, many tools such as PDSA and control charts are designed to ensure that we do not move forward without proving our implemented solution. If it doesn’t work, then it is time to think of a new solution. If you are unwilling to spend the time proving that your solution is successful then you should re-consider working on the project at all.

When it comes to tool fatigue, we can often be our own worst enemies. If we rush into projects without having the discipline to ensure that our efforts are targeted correctly and that our solutions were truly successful, we create unnecessary, unsustainable work for our colleagues. This has led QI/PI professionals to quickly adopt the phrase “go slow to go fast.”[2] To avoid spinning your wheels, address the key 4 elements with some level of discipline. Yet it doesn’t necessitate using the full tool box in every project. Finding the balance requires practice and patience.

[1] https://home.mainehealth.org/2/MMC/CenterforPerformanceImprovement/SitePages/Home.aspx

[2] https://ocw.mit.edu/courses/aeronautics-and-astronautics/16-660j-introduction-to-lean-six-sigma-methods-january-iap-2012/lecture-notes-1/

[3] Mann, D., 2014 “Creating a Lean Culture,” 3^rd Edition, Routledge, 2014

[4] https://medium.com/@reganbach/go-slow-to-go-fast-8c3055e723ed

Process Mapping & Flow Charts

Alan P. Picarillo, MD

Maine Neonatology Associates & the Maine Medical Center Department of Pediatrics.

Learning objectives

1. Understand the difference between simple and complex process maps.
2. Describe the steps to construct a process map.

Process mapping, also known as a flow chart, is a pictorial demonstration of the sequential steps involved in a process^1,2.  It may be a simple or complex tool, as each and every step of a procedure needed to deliver care (e.g. which steps are involved when an infant receives surfactant therapy) is documented.  Simple maps, also known as high level process maps, show how the process works in just a few steps. The purpose is to provide quick and easy insights into what the process does, without getting into the details of how it’s done. This simple map can be useful when communicating a process to leadership, but it does not encompass the details of each process step.  Complex process maps include significantly more detail than simple maps and may be required if the team is planning on streamlining an entire comprehensive process.  Creation of a complex map requires more team members and front-line participants in order to record the required details of each discrete step.

In order to be useful, process maps should not be created by a single individual, but rather by input of a multidisciplinary team.  The various members of the healthcare team provide an understanding of how each step may be influenced by the preceding or subsequent steps in a process.  By using process maps, the team is able to visualize how each member performs a step in a certain procedure, allowing for an improved understanding of each other’s roles and responsibilities during clinical situations. The value of the map created in a multidisciplinary meeting allows for discussion, and more importantly, understanding and appreciation of each other’s roles in discrete steps of the process.  This establishes a baseline knowledge of the process for all team members and once completed, the team proceeds with identification of steps that are wasteful and do not add value to the overall process.   The identification of important steps that add value to a process and the elimination of steps that do not add value are tenets of Lean management.  Lean management is a systematic method for removing waste from processes without impacting productivity an although Lean management has roots in manufacturing, it has been rapidly adopted by healthcare systems³

Creation of a process map does not need to be elegant or sophisticated; most successful process maps are created by pieces of paper representing each step that are then attached to the walls of a meeting room (Figure 1).  The use of this tool allows participants to discover that some of the steps in the procedure may involve delays in care, unnecessary/repetitive work or communication errors; all steps that add little value and may be able to be modified or even eliminated.  Further refinement of the process by the team can serve as a basis for designing a new and improved process.

1. Dias S, Saraiva PM. (2004). Use Basic Quality Tools To Manage Your Processes. Quality Progress, 37(8), 47-53
2. TrebbleTM, Hansi N, Hydes T,Smith MA, Baker M. Process mapping the patient journey: an introduction BMJ 2010; 341:c4078
3. Joosten T, Bongers I, Janssen R Application of lean thinking to health care: issues and observations. Int J Qual Health Care2009;21:341–7.

Figure 1

This is a process map detailing sixteen discrete steps for surfactant administration to premature newborns.  The yellow boxes detail steps where the team had identified barriers or waste and the red circles identify opportunities to administer surfactant to the newborn

Root Cause Analysis

Ghassan Saleh, DMD, DS-MaineHealth Director of Operational Excellence

Objectives

• Utilize root cause analysis in the planning phase of Plan-Do-Study-Act (PDSA) cycles
• Describe two RCA tools: the 5 Whys and Fishbone

When a patient visits his/her physician complaining about “headache,” the provider doesn’t simply deal with the symptoms. They try to figure out the underlying cause of the headache. They take a patient history, perform a physical examination, and do other investigations like blood work or imaging. They are interested in the root cause of the headache so that they can treat the headache and also prevent its recurrence.

Performing Root Cause Analysis (RCA) for a quality problem is essential during the “planning phase” of any Plan-Do-Study-Act (PDSA) cycle. RCA calls upon us to figure out and then solve the real cause(s) of the problem and helps to address more than its symptoms. This technique proposes that once we solve for the root cause, the same problem should not happen again or, at least, we significantly reduce the likelihood.

In quality circles we use RCA tools to drill deeper into the problem. There are number of RCA tools, but the most common two are 5 Whys and Fishbone. Both require us to take on the mindset of a five-year-old child. First we ask “why” did this happen? As soon as we answer the first question, we have to ask: “why” did this ever happen in the first place? Then, we continue to ask more “whys.” The difference between a five-year-old child and healthcare professionals is the cumulative wisdom that tells us to stop asking “why” once we feel that we have reached an actionable root cause to counteract.

5 Whys is used to break a linear problem into its root causes by asking why it happened multiple times, usually 5 times, or generally between 4 to 6 times. The Fishbone, on the other hand, is a tool that helps parse through a multi-factorial problem to its root causes. First, we identify categories of causes, and then we ask “why” multiple times for each one of those categories, while writing them down using the fishbone structure.

Figure 1 demonstrates the use of 5 Whys to discern the cause of a speeding ticket, and Figure 2 uses a fishbone to exemplify the root causes of cooking a “bad burger.”

In the healthcare setting, we often schedule formal gatherings to perform RCA to either discern gaps in the process of quality improvement or to analyze a clinical harm or near harm event in safety. The collective wisdom of subject matter experts provides the foundation for deconstructing the categories and asking the Whys for each branch of the Fishbone. A key to RCA process is to avoid transitioning too quickly into “solutions” – this poses the risk of premature closure and failure to identify a true root cause. Through patience and deliberate query, RCA helps us to identify the correct causes of our failures and expedite our journey to improvement and success.

Reference:

• 5 Why graphic: adapted from https://www.greycampus.com/blog/quality-management/how-do-you-determine-the-root-cause
• Fishbone graphic: reproduced from https://www.wallstreetmojo.com/fishbone-diagram/

MITE PSQI Hot Topic- March 2020:  Failure Mode(s) and Effects Analysis (FMEA)

Erin Graydon Baker, MS, RRT, CPPS, CPHRM

Clinical Risk Manager, MaineHealth

Learning Objectives:

1. Recognize the differences between Root Cause Analysis and Failure Mode(s) and Effects Analysis (FMEA)
2. Describe the application of FMEA techniques to any new or existing process

Failure Mode(s) and Effects Analysis (FMEA) versus Root Cause Analysis (RCA):

What’s the difference and which investigative, quality improvement method should I choose when evaluating harm or potential for harm? FMEA is a proactive risk assessment, whereas RCA is a reactive risk assessment.

RCA:

• A thorough and credible case review to identify basic or contributing factors underlying variation in performance
  • Focus is on processes, systems, and culture, not on individual performance
  • Focus relates to a specific case that either caused harm or had the potential to cause harm
• Thorough and credible is defined as multidisciplinary participation and inclusion of subject matter experts, facilitated by trained individuals.
• Uses Tools including time lines ( sequence of events) , fishbone diagram, action plans

FMEA:

• A systematic method of identifying and preventing process failures before they occur
• First formal FMEAs were conducted in aerospace industry to look for safety issues
• FMEA was used primarily to look at new processes to identify points of failure before launching a new process or product but is also used to review existing processes
• RCAs focus on how did particular adverse event occur whereas FMEAs focus on how could an adverse event occur
• RCAs can guide an FMEA; using specific cases to highlight system weaknesses
• FMEA similarly to RCA, uses tools to help evaluate potential failures
• FMEA starts with a flow/process map

FMEA brings subject matter experts, both optimists and pessimists, in a room together to review each step in a new or existing process. Typically, the facilitator(s) prepares a process map in advance of the exercise. Tracking through the process steps, the group discusses potential failures, the likelihood that certain failures will occur and the potential for harm to a patient or to operations if a failure occurs.  The likelihood (probability) and the potential for harm (severity) are each scored and then multiplied to assign a risk priority number, or RPN. The RPN helps the team prioritize which are the most vulnerable steps to fix.

This process can become more sophisticated by adding another variable such as ability to detect the failure before it happens. If we have alarms that warn us or electronic hard stops to prevent an error, we can decide that a particular step is safe and needs no intervention.

Once the high RPN step failures have been prioritized, the team assigns responsible persons to complete the corrective action items that will mitigate the chance of each failure occurring. Each responsible person will provide updates to the team and ask for help in removing barriers.

Once the FMEA action items are completed, the team measures the success and modifies the process as appropriate in PDSA (Plan-Do-Study-Act) format.

Here’s the sample template used to list the steps, failures, RPN scoring and action planning.

Anyone can do this process using this format. You must be sure that you have appropriate leaders who can help remove barriers engaged from the beginning of the process.

For more information; use the link provided or contact:

http://www.ihi.org/resources/Pages/Tools/Quality-Improvement-Essentials-Toolkit.aspx?utm_campaign=QI-Toolkit-Promotion&utm_medium=TopicLandingPage&utm_source=IHI

The Jigsaw Puzzle

 Omar Hasan, MD, MPH  Chief Quality Officer, MaineHealth

Choosing a suitable approach to accomplish a desired change can be challenging in the complex and dynamic hospital environment. Not infrequently, the person leading the change effort has a number of options that can be pursued to achieve the desired objective. Under these circumstances, it is helpful to choose the option that matches the complexity of the problem and the time available to address it. The schematic below illustrates this approach in a simplified way.

For troubleshooting minor issues, such as failure to consistently follow a few simple steps in a known protocol, applying Lean daily management (a part of MaineHealth’s Operational Excellence program, also referred to as ‘OpEx’) can help resolve the issue in a few short weeks. This same approach can also be used to address gaps from a known standard, such as failure to adhere to published clinical practice guidelines. In these cases, using OpEx methods and tools can highlight areas for improvement that can be prioritized for testing and implementing process changes using Plan-Do-Study-Act cycles.

Over time, technological advances or significant changes in clinical practice guidelines may require substantial redesign of clinical care delivery systems. This much change requires a more organized approach with appropriate attention to planning and project management. In some cases, rapid innovation or changing organizational needs necessitate a visionary and open-ended approach that leverages the full complement of systems engineering skills and practices to predict and manage the reconfiguration of teams and services.

As one engages in progressively more complex quality improvement projects over time, the morass of approaches used to accomplish change in a large teaching hospital begins to come into focus just like the picture formed by a jigsaw puzzle becomes clear as the pieces fit together.

Schematic adapted from Art Smalley http://artoflean.com