Henry S. Jennings III, MD, FSCAI; and Michael A. Kutcher, MD, FSCAI

The Situation

Your institution has just experienced an unfavorable outcome, or similar series of outcomes, in the cardiac catheterization laboratory (CCL) that clearly warrants an in-depth analysis and improvement in quality care delivery. One of the most useful tools available is a detailed root cause analysis (RCA), frequently in the context of the morbidity, mortality, and improvement (MM&I) conference, with usage of the specific RCA tool of fishbone (Ishikawa) diagrams. This SCAI-QIT Tip of the Month offers a succinct review of the value and implementation of such, and the incorporation of subsequent Plan-Do-Study-Act (PDSA) cycles in finding quality improvement (QI) solutions going forward. The basic temporal flow is “the event,” presentation at MM&I, and conducting the RCA using the fishbone diagram tool, ultimately prompting reiterative PDSA cycles in hopes of QI.

MM&I Conference

MM&I has long been a hallmark of teaching institutions that requires such to meet Accreditation Council for Graduate Medical Education (ACGME) requirements for residency and fellowship training programs; however, it has become ever more important for nontraining healthcare facilities to implement the same in the current era of quality-sensitive patient care. The format is to take a case or series of cases with a similar unfavorable outcome, carefully dissecting ex post facto/retrospectively the salient factors in specific domains that are potentially causative in such instances, then creating system and process changes to prevent them from transpiring again going forward. Although instinctively perceived by physicians as a negative and blame-placing event, the current and widely accepted modus is that of a nonpunitiveblameless, and just culture incorporating the opinions and input of all involved, inclusive not only of attending physicians but, importantly, nursing and administrative staff and the fellow trainees themselves. Each of these groups will have valuable input in a Health Care Quality Improvement Act of 1986 (HCQIA)-protected brainstorming session. The result is an open forum for all to suggest whatever they perceive to be salient factors in the undesired outcome being reviewed. Those directly involved with the specific case/cases to be discussed should be present. An effective senior discussion leader is imperative to guide the conference. Several references are attached for further in-depth descriptions of such conferences.1–6

Although this classic and well-described MM&I model may not be universally found in nonteaching and especially smaller CCLs/institutions, the model is well worth considering for hospital institutions to accomplish effective QI.

RCA

RCA is a retrospective tool in contrast to a failure mode and effects analysis (FMEA), which is inherently prospective in nature. Introduced into general industry (specifically manufacturing and aviation/aeronautical sectors) decades ago, this analytic process has particular relevance in the healthcare industry, specifically in patient safety and effective care delivery. The Joint Commission (TJC) requires institutions to have effective RCA for all sentinel events. RCA can lead the CCL team to uncover the specific factors that led to patient safety events and move the team to deliver safer care. The importance of competency in RCA for interventional cardiology trainees in their training curriculum has recently been recognized in a SCAI Consensus Statement/Core Curriculum document, and an extension of this requisite knowledge base to those in the CCL environment beyond trainees alone has been acknowledged.7

In fact, there are a large number of available tools that may be used in conducting RCA; these might include affinity diagrams, brainstorming, flowcharts, scatter diagrams, run charts, Pareto diagrams, process maps, “asking the 5 Whys,” and many others beyond the scope of this Tip of the Month, but well described in the TJC and American Society for Quality (ASQ) comprehensive and highly recommended references provided.8–13 These additional RCA tools will likely be of great interest to those with CCL QI oversight nonetheless.

Fishbone (Ishikawa) Diagrams

Of particular relevance and utility as a specific RCA tool in the MM&I environment is the “fishbone” diagram (Ishikawa diagram). Kaoru Ishikawa (1916–1989) was a Japanese organizational theorist and highly regarded professor at the University of Tokyo, and subsequently president of the Musashi Institute of Technology. His conception of the highly visual “fishbone” diagram of cause and effect analysis/RCA is regarded as an important contribution to QI. He is considered one of the most notable individuals in the history of QI, along with Walter A. Shewhart, W. Edwards Deming, Joseph M. Juran, and others.

Ishikawa diagrams are formatted in which contributing factors in a few selected domains are listed and analyzed by the RCA focus group. Examples of the most frequently chosen domain headers for these “bones” of the “fish” would include the “4Ps” (place, procedure, people, policies), the “4Ms” (methods, machines, materials, manpower), or the “4Ss” (surroundings, suppliers, systems, skills). Subsidiary factors are then gathered through group brainstorming, adding additional items as secondary “ribs” of the major domain “fishbones.” Useful domain categories for the “bones” of this diagram in the RCA effort in MM&I might include Equipment/Supplies, Rules/Policies/Procedures, Communication, Staff/People, Environment, or various combinations of these as the particular situation dictates. A template diagram frequently used at Vanderbilt Heart & Vascular Institute is seen in Figure 1.

PDSA Cycles

W. Edwards Deming (1900–1993) advocated using reiterative Plan-Do-Check-Act cycles proposed initially by Shewhart, and occasionally referred to as “Shewhart cycles” (now known as PDSA cycles), in modern industrial quality control using the principles of careful focus group selection/inclusion of stakeholders, brainstorming, affinity diagrams, flowcharts, and other tools to direct focused attention to a given problem, as identified by thoughtful RCA. PDSA cycles are often used to assess process measures and to determine whether best practices have been followed. The focus group should plan, initiate/do a new process change, check/study the results, and act upon the results. After careful RCA and Ishikawa diagram analysis, utilizing the repetitive PDSA cycle framework would be the logical tool for implementing change in pursuit of QI. The sequential steps are outlined below.

The Four Steps of a PDSA Cycle

1. Plan

  • Define the current situation/system and gather data to describe the current process.
  • Identify causes of variation or problems and develop theories to address them.
  • Define specifically what you are trying to accomplish.
  • Obtain buy-in from key stakeholders.
  • Identify ways to counteract resistance to change.
  • Develop a communication plan.

2. Do

  • Implement the plan.
  • Record any unexpected events and other observations.
  • Begin analyzing the data.

3. Study

  • Monitor outcomes.
  • Determine if the interventions improved the process/problem.
  • Evaluate the need for modifications to the approach.
  • Identify additional areas for improvement.

4. Act

  • Decide if it is appropriate to implement the plan broadly, modify it, or discard it.
  • Develop a monitoring schedule to measure the gains over time.
  • Determine if processes can be improved further.

Summary

This SCAI-QIT Tip of the Month has reviewed the framework of MM&I, the importance and fundamentals of RCA, the specific utility of cause and effect/fishbone diagramming in RCA in the CCL environment, and the potential usefulness of PDSA cycles after thorough RCA for undesired CCL events. Useful references are given for those who may desire to pursue these concepts in more depth and learn about these and other available tools for accomplishing improved patient safety and QI in the CCL.

References

  1. Orlander, JD, et al. “The Morbidity and Mortality Conference: The Delicate Nature of Learning from Error.” Acad Med, 2002. 77:1001-1006.
  2. Deis, JN, et al. Henriksen K, et al., editors. “Transforming the Morbidity and Mortality Conference into an Instrument for Systemwide Improvement.” Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 2: Culture and Redesign). Rockville, MD, 2008.
  3. Reason, J. “Human Error: Models and Management.” BMJ, 2000. 320:768-770.
  4. Higginson, J, et al“Mortality and Morbidity Meetings: An Untapped Resource for Improving the Governance of Patient Safety.” BMJ Qual Saf, 2012. 21:576-585.
  5. Szostek, JH, et al. “A Systems Approach to Morbidity and Mortality Conference.” Am J Med, 2010. 123:663-668.
  6. Bechtold, ML, et al. “Educational Quality Improvement Report: Outcomes from a Revised Morbidity and Mortality Format That Emphasized Patient Safety.” Qual Saf Health Care, 2007. 16:422-427.
  7. Jennings, HS, et al. “SCAI Core Curriculum for Adult and Pediatric Interventional Fellowship Training in Continuous Quality Assessment and Improvement.” Cathet Cardiovasc Interv, 2015. 86:422-431.
  8. Root Cause Analysis in Health Care: Tools and Techniques. 5th edition. The Joint Commission. Oakbrook Terrace, IL: Joint Commission Resources, 2015.
  9. Rabol, LI, et al. “Descriptions of Verbal Communication Errors Between Staff: An Analysis of 84 Root Cause Analysis – Reports from Danish Hospitals.” BMJ Qual Saf, 2011. 20:268-274.
  10. Friedman, AL, et al. “Medication Errors in the Outpatient Setting: Classification and Root Cause Analysis.” Arch Surg, 2007. 142:278-284.
  11. Morath, JM, Turnbull, JE. To Do No Harm: Ensuring Patient Safety in Health Care Organizations. San Francisco: Jossey-Bass, 2005.
  12. Taque, NR. The Quality Toolbox. 2nd edition. The American Society for Quality. Milwaukee: Quality Press, 2005.
  13. Langley, GL, et al. The Improvement Guide. 2nd edition. San Francisco: Jossey-Bass, 2009.

Figure 1. Potential Fishbone Template for RCA in the MM&I Conference

*Major domain categories (highlighted) are the “bones”; subsidiary “ribs” are added, as needed.

 

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