Healthcare Failure Mode and Effect Analysis (HFMEA)
Students individually complete a rudimentary Healthcare Failure Modes and Effects Analysis (HFMEA) of the process of subcutaneous injection of insulin (high-alert medication) in a hospital setting.
HFMEA is a systematic, proactive method for evaluating a healthcare process to identify where and how it might fail and to assess the relative impact of different failures, in order to identify the parts of the process that are most in need of change. HFMEA includes review of the following:
• Steps in the process
• Failure modes (What could go wrong?)
• Failure causes (Why would the failure happen?)
• Failure effects (What would be the consequences of each failure?)
Teams use HFMEA to evaluate processes for possible failures and to prevent them by correcting the processes proactively rather than reacting to adverse events after failures have occurred. This emphasis on prevention may reduce risk of harm to both patients and staff. HFMEA is particularly useful in evaluating a new process prior to implementation and in assessing the impact of a proposed change to an existing process.
Step One: Select the process (which has been done for you in this case)
Evaluation using HFMEA works best on processes that do not have too many sub-processes.
Therefore, instead of doing an HFMEA on a large and complex process, such as medication management in a hospital, complete a HFMEA on a smaller component of this process which equals medication administration of insulin (for this assignment). Do not necessarily focus on an adverse event but rather proactively on this process.
Step Two: Assemble the team
Discuss who would comprise the multi-disciplinary or inter-professional team with rationale as to why they should be on this team.
Step Three: Diagram the process
List all the steps in this sub-process; utilize the posted HFMEA form and list the steps in sequential order (try to keep to 10 steps at maximum for this exercise.)
Step Four: Brainstorm failure modes and causes
Select 1 higher priority step in the process, list a few (2-3) possible “failure modes”—that is, anything that could go wrong. Then, for each failure mode listed, identify some (2-4) possible causes (for an actual HFMEA, the team would note ALL failure modes and ALL possible causes but we want to keep this exercise manageable). Also, note what would be the effect (or consequence) if the priority step failed.
Step Five: Determine the Risk Priority
For each failure mode, assign a numerical value (known as the Risk Priority Number, or RPN) for likelihood of occurrence, likelihood of detection, and severity as follows:
• Likelihood of occurrence: How likely is it that this failure mode will occur? Assign a score between 1 and 10, with 1 meaning “very unlikely to occur” and 10 meaning “very likely to occur.”
• Likelihood of detection: If this failure mode occurs, how likely is it that the failure will be detected? Assign a score between 1 and 10, with 1 meaning “very likely to be detected” and 10 meaning “very unlikely to be detected.”
• Severity: If this failure mode occurs, how likely is it that harm will occur? Assign a score between 1 and 10, with 1 meaning “very unlikely that harm will occur” and 10 meaning “very likely that severe harm will occur.” In patient care examples, a score of 10 for harm often denotes death.
Step Six: Select the priority failure modes
Calculate the total RPN for each failure mode (the Excel HFMEA form already has this formula built in) by multiplying the 3 sub-scores (2 likelihood and 1 severity ratings). Failure modes with high RPNs are probably the most important parts of the process on which to focus improvement efforts. Failure modes with very low RPNs are not likely to affect the overall process very much, even if eliminated completely, and they should therefore be at the bottom of the list of priorities.
Step Seven: Outline actions
For the top priority failure mode (the highest overall RPN), list a few possible actions (see attached safety action types) to address harm from the failure mode. Justify these actions with a brief summary analysis (2-3 pages maximum) noting the strength of the action and the rationale for implementation to avoid process failure.
1. Using the provided HFMEA form (in Excel):
a. List 10 major steps in the process (in sequential order)
b. Select 1 higher priority step and list 2-3 possible failure modes
c. For each failure mode, list 2-4 possible causes with consequences
d. For each failure mode, calculation a RPN (3-part scoring; formula built in Excel form)
2. In WORD format (3 pages maximum):
a. Describe the process (at what point does it begin and end?)
b. Propose the composition of the HFMEA team (with rationale as to why members should be on this team)
c. Briefly summarize the top priority step selected and the top failure mode (with the highest RPN) with rationale for priority ratings.
d. Outline an action plan to address potential harm reduction from failure mode. (brief) Justify these interventions with rationale and note the strength of the action.
e. Include approximately 5 references (reference page is not included in the 3 pages summary analysis) using APA 6th edition formatting.
What should be posted to the respective assignment folder by the posted deadline?
1. HFMEA form (in Excel)
2. Summary Analysis (in WORD) 3 pages content and an additional references page; include a title page.
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