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Medication Errors and Patient Safety Concerns

Root cause analysis (RCA) is a method used to determine the cause of an adverse event, such as a sentinel event (unexpected death, clustered adverse events). RCA is an integral part of reducing medical error. Because RCA is retrospective, it requires interviews with those involved, questionnaires, observations of processes and procedures, and medical record review. Every step in a process or procedure may be traced, focusing on why and how things are done rather than on the individuals who are carrying out the processes. Usually RCA includes a review of literature and study of best practices to determine the best solutions to the problems discovered through the RCA when developing an action plan. An action plan to solve a problem without RCA may be ineffective. If, for example, contaminated airflow has caused surgical infections, altering the method of disinfecting the surgical suite will not decrease infections. There are a variety of alternative methods that may be used to conduct RCA:

  • 5 Whys: This method, originally used by Toyota in Japan, utilizes a team with knowledge of the process to be analyzed. The team asks a series of

at least 5 “Why?” questions to reach cons arose. It begins with a complete detailed outline of a procedure or process

and then questions about each separate step:

o Why did the patient take an overdose of medication? Because she didn’t understand the directions.

o Why didn’t she understand the directio read English.

o  And   so   on……

  • Is –Is not: This method attempts to identify root cause by evaluating a problem in terms of what it is and is not. A 2-column table with the

problem listed at the top is created. One column heading other column heading is “Is not.”

o Is: A detailed description of the problem is identified through the asking of information questions about the process.

o Is not: This identified alls those factors/event that MIGHT have caused the same problem but did not.

o The two lists are then examined to determine what differentiates them in order to determine root cause.

  • Failure mode and effects analysis (FMEA): This RCA is different from the others because it is done prospectively instead of retrospectively. That is, when a new process or procedure is proposed, the FMEA is done to determine all possible problems/failures that may arise and to correct processes in advance. This is a form of risk assessment that involves creating a very detailed flow chart of a process/procedure and then brainstorming every step and sub-step for potential problems, asking

“What could go wrong?” All potentialed ad and ranked according to severity, with causes and effects identified

through RCA, 5-Whys or other methods. Performance measures are identified as part of the analysis.

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