Patient Safety

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69 Terms

1

What is patient safety?

 Includes prevention of diagnostic errors, medical errors, injury or other preventable harm to a patient during the process of health care and reduction of risk of unnecessary harm associated with health care. (AHRQ definition).

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2

How are patient safety and QI are closely related?

  • Patient safety initiatives aim to identify and then prevent/mitigate harm that results from treatment.

  • QI improvement initiatives focus on ensuring that all patients receive appropriate care in a timely fashion (achieve best possible health outcomes). 

  • Distinct goals, systems, and methods for each. 

    • Still has a lot of overlap for tools. 

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What is a safety event?

Situation where best or expected practice does not occur.  If it is followed by serious harm to a patient, it’s called a “Serious Safety Event (SSE)”.

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What are the 3 Main Types of Patient Safety?

Individual Safety Practice, Safety Events, Systems Safety

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What does Individual Safety Practice mean?

At the individual personnel/provider level.

  • Practice infection-control and standard safety precautions.

  • Role model and practice specific protocols. 

  • Practice self-care to prevent burnout, fatigue, and apathy.

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What does Safety Events?

At the patient care level.

  • Evaluate safety performance of your team and colleagues.  Diagnose safety events (types of errors/recognizing safety events when you see them).

  • Reporting safety events through the proper reporting systems.

  • Role model the disclosure of patient safety events. 

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What does Systems Safety mean?

At the systems level, looking at the clinical processes put in place. 

  • Work as a part of an interprofessional team in a complex system.

    • Use effective communication.

    • Promoting a just-culture framework (safety culture).

  • Uses clinical processes and protocols designed to reduce error (called the human factor design).

  • Incorporates patient safety tracking systems and institutional patient safety initiatives. 


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O: Know the four types of Medical Errors

What is Medical Error?

May involve incorrect patient identification, diagnosis, monitoring, nosocomial infections, medications, procedures, devices, documentation, or handoff. 

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What is Active Error?

Error occurs at the frontline of care (when treating a patient).  The error will result in an immediate impact on the patient.

  • Example: Patient is given the dosage of a medication. 

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What is Latent Error?

Error occurs in the processes associated with patient care, indirectly from the operator (person treating the patient in that moment).  There is no immediate impact, but is considered to be an “accident waiting to happen”.

  • Example: Patient’s allergies are not updated within their chart.

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What is Never Event?

A severe, major error that should never occur.  These errors are typically preventable through safety systems. 

  • Are reportable through the National Quality Forum (PSO), and given to consumers through a published list of these never events. 

  • Example: Patient death from anaphylaxis reaction to a medication given to a patient with a known allergy.

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What is Near-Miss?

Unplanned event that doesn’t result in harm, but has the potential to cause harm.

  • Narrow prevention of harm can actually expose dangers.

  • Example: Pharmacist recognizes a medication interaction and cancels the order before it causes any problems. 

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LO: Identify the factors that contribute to medical errors.

What are the three Common misconceptions about adverse events and medical errors?


Misconception 1: “Bad apples” or incompetent health care providers are a common cause of medical errors. 

  • Reality: Most errors are a normal human slip or lapse. 

Misconception 2: High risk procedures or medical specialties are responsible for most avoidable adverse events.

  • Reality: Most adverse outcomes are due to the severity of the medical condition rather than the complexity of the procedure.

Misconception 3: If a patient experiences an adverse event during the process of care, an error has occurred.

  • Reality: Most medical care entails some level of risk, and there can be complications or side effects, even unforeseen ones, from the underlying condition or from the treatment itself.

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What are the 3 Main Types of Factors that Contribute to Medical Errors?

Medical Complexity, Systems Failures, Human Factors: Burnout and Fatigue

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What is Medical complexity?

  • Patient/condition complexity such as rare or severe disease states with multiple comorbidities. 

  • Length of stay and level of care intensity (ICU)

  • Unfortunately, there isn’t much we can do to prevent these medical errors. 

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What is Systems Failures?

Swiss cheese model. 

  • Focuses on systems and conditions rather than an individual’s errors. 

  • The risk of a threat becoming a reality is mitigated by different layers and types of defenses. 

  • Patient harm can occur despite these multiple safeguards when the “holes of the cheese” line up.

The most vulnerable time for these “holes” to line up include…

  • Transition of care from one provider to another (shift changes or hospital transfers). 

  • Miscommunication between the layers of personnel caring for the patient. 



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17

What is burnout?

Results from prolonged and excessive stress. 

  • Leads to cynicism, detachment, decreased motivation, and interest. 

  • Sense of failure and helplessness, decreased immunity. 

  • Medical errors can occur due to reduced professional efficacy. 

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What is fatigue?

Results from sleep deprivation.

  • Leads to decreased energy, motivation, and cognitive impairment. 

  • Medical errors can occur due to compromised intellectual function. 

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What are the five stages of burnout?

Stage 1: Honeymoon Phase.

Stage 2: Onset of Stress.

Stage 3: Chronic Stress

Stage 4: Burnout

Stage 5: Chronic Burnout

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What is the Stage 1: Honeymoon phase?

  • Commitment to the job and a high level of job satisfaction.

  • Sustained energy levels and unbridled optimism. 

  • Accepting responsibility and a compulsion to prove oneself.

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What is the Stage 2: Onset of stress?

  • Inability to focus and lowered productivity. 

  • Lack of social interaction and avoidance of decision making. 

  • Neglect of personal needs and changes in appetite.

  • Irritability and reduced sleep quality. 

  • Headache and anxiety.

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What is Stage 3: Chronic stress?

  • Persistent tiredness and chronic exhaustion. 

  • Social withdrawal and apathy. 

  • Resentfulness and a cynical attitude. 

  • Feeling threatened, pressured, and aggressive. 

  • Denial of problems, alcohol/drug consumption. 

  • Procrastination and decreased sexual desire.  

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What is Stage 4: Burnout?

  • Obsession with problems

  • Physical symptoms such as chronic GI problems and chronic headaches. 

  • Social isolation and self-doubt. 

  • Neglect of personal needs. 

  • Behavioral changes and escapst activities.

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What is Stage 5: Chronic Burnout?

  • Chronic sadness.

  • Chronic mental fatigue.

  • Chronic physical fatigue.

  • Depression.

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25

LO: Recognize Human Factors Design

What is the Human Factors Design?

 A scientific discipline that aims to help people do their best work, improve resilience and overall system performance, and minimize errors. 

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HF Design recognizes that design deficiencies hinder

  • workflow and leads to staff workarounds that bypass safety features. 

    • Example: ID barcodes being affixed to computers due to unreadable wristbands on the patient. 

  • To reduce/prevent harms, the healthcare environment must be designed with human limitations and abilities in mind

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What is the most effective type of process design?

Forcing Function

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What is forcing function?

 A healthcare environment process design choice that makes it impossible to do a task incorrectly.  

  • Example: Connectors to the oxygen and nitrous oxide gas containers that are designed to be impossible to physically connect to the wrong cylinder.

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What is standardization?

Creating guidelines and establishing the flow for a particular process. 

  • Helps to improve the reliability of a process. 

  • Relies on evidence-based medicine to create the standard.

  • Example: Clinical pathways, algorithms, guidelines, and checklists.  (Flowchart to the right).

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What is simplification?

Reducing the number of steps in wasteful activities; Therefore making less opportunities to make mistakes (seen above). 

  • Example: Having all hospital admission orders contained within one order set. 

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31

LO: Define Safety Culture and understand Medical Error Reporting and Disclosure. 

What is Safety Culture?

Organizational environment in which patient safety is highly valued and everyone is expected to participate in practicing patient safety and report patient safety events. 

  • Everyone can freely bring up safety concerns without fear of penalty.

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Safety culture relies on a just 
culture model rather than a blame culture model.
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What is Blame culture?

Professional culture in which the who is more important than either the why or how. 

  • Example: Being focused on who made the mistake, rather than why the mistake was made and how it was made (where were the systematic holes?).

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What is just culture?

(or a no-blame culture): Professional culture that seeks to understand the root cause of an error rather than just the person(s) involved in the error. 

  • Helps to facilitate error identification: Person who made the error doesn’t feel defensive (or that they’ll face ramifications) will share how/why they made the mistake.

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What is Medical Error/Adverse Event Reporting: Internal Event Reporting Systems?

Even in the most robust safety cultures and best practices, medical errors happen. 

  • Ubiquitous in hospitals and are a mainstay of efforts to detect patient safety events and quality problems. 

  • Rely on those frontline personnel involved in the event to voluntarily report, rather than management or patient safety professionals. 

  • Example: The VOICE reporting system at LUMC.  

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What is Medical Error/Adverse Event Reporting: External Event Reporting Systems and what was the law enacted?

  • Illinois adverse health care events reporting law of 2005.

    • Mandates NQF “never events” be reported to IDPH. 

  • CMS Core Measurements

    • Includes patient safety measures (e.g. CAUTI, CLABSI, patient falls, nosocomial infections, etc…)

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All adverse events including non-harmful events should be…..


  • disclosed to the patient as openly and as soon as possible.

    • Many studies show that transparency and openly disclosing adverse events reduces the likelihood of being sued. 

  • Disclosing adverse events should be left to the attending.  The manner in which it is disclosed is important. 

  • Risk management may need to be consulted prior to the disclosure. 

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What is the Root Cause Analysis?

A structured method used to analyze serious adverse events. 

  • Employs tools to retrospectively study events where patients were harmed or there was an undesired outcome in order to identify the and address the root cause for the adverse event. 

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LO: Recognize the most common methods of Medical Error Analysis. 

What is the Medical Error Analysis:


The systematic approach to the detection, reporting, analysis, and tracking of risk/harm from medical errors.

  • Structured and methodical process approach in order to be effective and consistent through time.

  • Requires a collaborative, multi-disciplinary approach in order to provide the most efficient and practical information. 

  • Distinguishes between types of data and tracking methods for targeting patient-safety. 

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What are the 2 Most Commonly used Medical Error Analysis Methodologies?

  1. Root Cause Analysis (RCA): Used retrospectively. 

  2. Failure Model and Effects Analysis (FMEA): Used prospectively. 

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What are the components and process of Root Cause Analysis?


Design of Analysis: Uses a retrospective approach.  Is applied after a failure event to prevent recurrence. 

  • Methods: Uses records and participant interviews to identify all the underlying problems that led to an error.  Can also use the IHI 6 steps. 

    • Participants should be multidisciplinary and at multiple levels of jobs in the employment hierarchy. 

    • Problems include anything about process, people, environment, equipment, materials, or management. 

  • Tools: 5 Whys, Timeline, Process Map, Fishbone Diagram, Driver Diagram (etc…)

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Root Cause Analysis depends on the system using a 

Just Culture

  • Starting point of an RCA is that individuals involved in an error event are well-intended, reasonable, and competent. 

    • If an individual was displaying willful neglect or harm, then an RCA is not an appropriate tool for that circumstance. 

  • RCA starts by looking at the systems level (rather than blaming an individual). 

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Root Cause Analysis will Investigate

System Failures (Swiss Cheese Model)

  • Accidents in healthcare almost never stem from a single, linear cause. 

    • They come from a mix of activity failures, work conditions, and deeply embedded latent failures. 

    • There are contributory factors that all align precisely to slip through every existing defense. 

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Root Cause Analysis: How is it’s performed in a Hospital?

  • Typically involves a committee whose members have expertise in doing RCA.  

    • Committee is a team of 4 to 6 people from different professional disciplines. 

  • Team should include individuals from all levels of the organization who are close to/have fundamental knowledge of issues and processes involved in the incident.  

  • RCA team composition is institution dependent.

    • Should those involved in the event participate?

    • Should patients and their families participate?

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What are the Root Cause Analysis Six Steps to an RCA from IHI**

Identify what happened:

Determine what should have happened:

Determine causes:

Develop a causal statement:

Generate a list of recommended actions to prevent the recurrence of the event.

Write a summary and share it.  

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Explain the identify what happens stage from the Six Steps to an RCA from IHI*

  1. Using a timeline to plot out the event.

  • Describe what happened accurately and completely. 

  • Laying out events in chronological order. 

  • Useful to group the event into categories which can help you understand the event in a different way. 

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Explain the identify Determine what should have happened stage from the Six Steps to an RCA from IHI*

  • Determine what would have happened in ideal conditions. 

  • Looking through the literature to see what is typically done and what/why it's done that way. 

  • Can be useful to create another timeline/chart about the ideal event and compare it to the timeline of what actually happened. 

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Explain the identify Determine causes stage from the Six Steps to an RCA from IHI*

Writing out the factors and grouping them using a fishbone diagram. 

  • Team looks at the direct causes (the most apparent ones) and contributory factors (indirect in nature) during this process. 

  • Experts recommend asking the team “Why?” five times to get to the underlying root cause. 

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Explain the identify Develop a causal statement: stage from the Six Steps to an RCA from IHI*

A causal statement has three parts. 

  • The Cause: “This happened…”

  • The Effect: “...which led to something else happening…”

  • And then Event: “...which caused this undesirable outcome.”

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Explain the identify Generate a list of recommended actions to prevent the recurrence of the event. stage from the Six Steps to an RCA from IHI*

  • Recommendations often fall into one of these categories…

    • Standardizing equipment

    • Ensuring redundancy (using double checks/backup systems)

    • Using forcing functions that physically prevent users from making common mistakes. 

    • Using cognitive aids (checklists/labels/mnemonic devices)

    • Simplifying a process

    • Educating staff

    • Developing new policies

    • Updating or improving software. 

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Explain the identify Write a summary and share it stage from the Six Steps to an RCA from IHI*

  • Can be an opportunity to engage the key players to help drive the next steps in improvement. 

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LO: Demonstrate understanding of common tools used in Root Cause Analysis (Timeline, 5 Whys, Fish-Bone Diagram)


Timeline: Helps with demonstrating the

 flow of events when both identifying what happened and what should have happened.  

  • Comparisons between the two can help the RCA better understand the adverse event.

Creating an “Ideal Process” map to represent what should be done.

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What is the fishbone diagram?

Helps depict the various causes (and what categories/groups they fall under) for a particular event.  Aids in the understanding of what went wrong…

  • Can be used to pick-out and identify the areas that are actionable for a QI project. 

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What are the five why’s?

  • Technique to ascertain why an event happened and determine the root cause. 

    • Continue asking “Why?” 5 times to further explore an event.

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LO: Recognize the component and process of Failure Mode and Effects Analysis.

What is the Failure Mode and Effects Analysis?


Systematic and proactive method for evaluating a process to identify where and how it might fail.  Assesses the relative impact of different failures in order to identify the parts of the process in need of change. 

  •  FMEA is a proactive approach, it tries to anticipate adverse events before they occur.

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What is the Failure Mode and Effects Analysis Design?

Forward looking approach.  Applied before process implementation to prevent failure occurrence.

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What is the Failure Mode and Effects Analysis Methods?

Uses records and participant interviews to identify all the underlying problems that led to an error.  Also uses inductive reasoning to identify all the ways a process might failand prioritizes them by their probability of occurrence and impact on patients.

  • Uses a five step model. 

  • Gives you a direction about where you should focus your efforts/your work by weighing:

    • Things that are likely to occur frequently.

    • Things that are hard to detect that could be catastrophic.

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What is the Failure Mode and Effects Analysis Tools?

Uses a Failure Mode and Effects Analysis Chart.

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What are the Five Steps of Failure Mode and Effects Analysis?

Select a process to evaluate,

Recruiting a multidisciplinary team…?,

List all of the steps in the process of interest:,

Filling out the FMEA table with your team,

Use RPNs to plan improvement efforts.

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What is the Select a process to evaluate step?

  1. Useful for a new process or assessing the impact of a change to an existing process. 

  • Ideally isn’t a process that has too many sub-processes/complexities. 

  • Helpful to further subdivide complex processes…

    • Divide up something like medication management into smaller processes for separate FMEA such as dispensing and administration processes.

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What is the Recruiting a multidisciplinary team step?

  • Include a representative from any discipline that will be involved at any point within the FMEA process. 

  • Usually includes pharmacists, doctors, nurses… can also include patient transporters, techs (or anyone else involved).

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What is the List all of the steps in the process of interest step?

  1. Often involves a process map/flow chart for all of the different elements that are involved in a process.

  • Similar to the ideal process map seen above in the RCA analysis model. 


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What is the Filling out the FMEA table with your team step?

This table includes items such as…

  • Failure Mode: What could go wrong?

    • List anything that could go wrong during a particular step in the process. 

  • Failure Causes: Why would the failure happen?

    • List all of the possible causes for each of the failure modes you identified. 

  • Failure Effects: What would be the consequence of the failure?

    • List all the possible adverse consequences for each of the failure modes identified. 

  • Likelihood of Occurrence (1-10): What is the likelihood the failure mode will occur?

  • Likelihood of Detection (1-10): What is the likelihood that the failure mode will NOT be detected if it does occur. 

  • Likelihood of Detection (1-10): What is the likelihood that if the failure does occur, it will cause severe harm. 

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What do you use the FMEA table for?

  • Calculate the risk profile number (RPN) from the above three metrics. 

    • Occurrence Detection Severity = RPN 

    • The lowest possible score will be 1 and the highest will be 1000.

    • To calculate the RPN for an entire process, add up the individual RPNs for each of the failure modes that make up a process. (A failure mode is an individual step where something could go wrong).

  • Determine actions to reduce the occurrence of failure: Listing out the possible actions to improve safety systems, especially for failure modes with the highest RPNs. 

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What is the Use RPNs to plan improvement efforts step?

  • Prioritizing RPNs

    • Focusing on failure modes with high RPNs are the most important parts of a process to concentrate improvement efforts on.

    • Failure modes with low RPNs are not likely to affect the overall process much (even if eliminated) and should be at the bottom of the priority list.

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Plan actions to reduce harm 1: If the failure mode is likely to occur..?

  • Using forcing function if possible: A physical constraint that makes committing an error impossible (example being making gas outlets that only accept the appropriate matching gauge). 

  • Adding an additional verification check. 

    • Examples: Independent double checks, bar coding on medications, alert screens…

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Plan actions to reduce harm 2: If the failure mode is unlikely to be detected…

  • Identifying “flags” if possible.  What could be used to identify the failure mode?

    • Identify other events that may occur prior to the failure mode (if the failure mode itself can’t be flagged) to indicate that the failure mode might occur. 

  • Adding a step to the process that intervenes at the earlier event to prevent the failure mode.

    • Examples: Adding hourly rounds for pharmacy techs to remove discontinued medications from patient’s drawers to reduce risk of them being given.

  • Consider adding alerts for EMR or devices to alert users when values are approaching unsafe limits. 

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Plan actions to reduce harm 3: If the failure mode is likely to cause severe harm…

  • Identify early warning signs that a failure mode has occurred and train staff to recognize them for early intervention. 

    • Use drills to train staff by simulating events that lead up to failure, to improve staff ability to recognize these early warnings

    • Example of early warning signs would be the MUSE score for sepsis we use at Loyola: Epic calculates a muse score based on the vital signs and fires and alerts if the score gets to a certain threshold of severity.  This is to try to catch the patients who are likely to have respiratory or circulatory failure from sepsis.

  • Providing information and resources such as reversal agents or antidotes at points in care for events that may require immediate action. 

    • Examples: Narcan in the crash carts in the ER. 

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In conclusion, FEMA charts can be powerful because

they are proactive.  They help with both identifying preventive interventions and prioritize and direct appropriate actions.

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