CPOM Module 16, Section 3: Risk Assessment Using FMEA and Incident Trends
MODULE 16: QUALITY MANAGEMENT & MEDICATION SAFETY

Section 16.3: Risk Assessment Using FMEA and Incident Trends

A guide to proactive risk identification, focusing on Failure Mode and Effects Analysis (FMEA) to analyze and mitigate risks in new processes, and trend analysis to identify patterns in incident data.

SECTION 16.3

Risk Assessment Using FMEA and Incident Trends

From Fortune-Telling to Failure-Proofing: The Art of Proactive Safety.

16.3.1 The “Why”: The Moral Imperative of Proactive Risk Assessment

In the previous section, we mastered the art of the post-mortem. We learned how to take an error that has already occurred and, through a rigorous Root Cause Analysis, learn from it to prevent its recurrence. This is a critical, foundational skill for any safety-conscious leader. However, a safety program built entirely on reactive analysis is, by definition, a program that is always one step behind disaster. It requires a patient to be harmed (or nearly harmed) before a system flaw is identified and fixed. While we must learn from our mistakes, we have a higher, moral obligation to prevent them from happening in the first place.

This is the fundamental principle of proactive risk assessment. It is the deliberate, systematic practice of looking into the future of a new process, a new technology, or a new drug protocol and asking the simple, powerful question: “How could this go wrong?” It’s about putting on a “pessimist’s hat” and imagining all the potential failure points before they have a chance to materialize. This is a profound shift in mindset, from being a forensic investigator of past failures to being an architect of future successes. It is arguably the most advanced and highest-leverage activity a Pharmacy Operations Manager can engage in.

Waiting for an adverse event to happen to expose a system flaw is like waiting for a house fire to realize you need smoke detectors. A proactive safety culture installs the smoke detectors, checks the wiring, and buys a fire extinguisher before the house is even built. The two primary tools for this work are Failure Mode and Effects Analysis (FMEA), a method for dissecting a future process to find its hidden risks, and Incident Trend Analysis, the practice of using your “near-miss” data as a crystal ball to see where the next real disaster is most likely to strike. Mastering these tools will elevate you from a manager who cleans up messes to a leader who prevents them.

Retail Pharmacist Analogy: Launching a New High-Risk Medication Service

Imagine your pharmacy has been selected to be the first in your district to dispense a new, complex oral chemotherapy agent for home use. It has a narrow therapeutic index, requires special handling, has significant drug interactions, and costs thousands of dollars per prescription. Your District Manager’s only instruction is, “Don’t mess this up.”

  • The Reactive (and Reckless) Approach: You wait for the first prescription to arrive. You and your staff scramble to figure it out. You realize you don’t have the right auxiliary labels, you’re not sure how to bill it, and you don’t have a good way to document patient counseling. You make it through the day with a few near misses, hoping for the best. You are waiting for an error to teach you what you should have known.
  • The Proactive (FMEA) Approach: Weeks before the launch, you assemble your lead technician and another pharmacist. You get out a whiteboard and you perform an informal Failure Mode and Effects Analysis. You map out the entire future workflow:
    1. Process Step: Receiving the prescription.
      • What could go wrong? (Failure Mode): The dose could be written incorrectly by the oncologist.
      • What’s the consequence? (Effect): Catastrophic overdose or underdose.
      • How do we prevent this? (Action): Create a mandatory checklist that requires calling the oncologist’s office to verbally verify the dose against the protocol for every new prescription.
    2. Process Step: Storing the medication.
      • What could go wrong? (Failure Mode): A technician could accidentally store it with the regular stock instead of in the designated hazardous drug area.
      • What’s the consequence? (Effect): Staff exposure, potential for it to be returned to stock incorrectly.
      • How do we prevent this? (Action): Order a special, bright yellow bin for the shelf. Implement a software rule that the drug cannot be received into inventory unless the “Hazardous Drug Storage” location is scanned.
    3. Process Step: Dispensing to the patient.
      • What could go wrong? (Failure Mode): The pharmacist on duty might forget to counsel on the critical need to avoid grapefruit juice.
      • What’s the consequence? (Effect): Potentially fatal drug interaction.
      • How do we prevent this? (Action): Create a mandatory, hard-copy counseling sheet that the patient must sign. The pharmacy software is configured so the prescription cannot be sold unless the pharmacist scans the barcode on the signed counseling sheet.

By systematically walking through the process and imagining the failures in advance, you have designed a safer system from the ground up. You have built in forcing functions, checklists, and redundancies. You have transformed anxiety about a new process into a confident, well-designed workflow. This structured, proactive paranoia is the essence of an FMEA.

16.3.2 Failure Mode and Effects Analysis (FMEA): A Deep Dive into the Methodology

Failure Mode and Effects Analysis (FMEA) is a step-by-step, prospective approach for identifying all possible failures in a design, a manufacturing or assembly process, or a product or service. “Failure modes” are the ways, or modes, in which something might fail. “Effects analysis” refers to studying the consequences of those failures. It was originally developed by the U.S. military and famously used by NASA in the 1960s to anticipate and prevent rocket failures during the Apollo missions. In healthcare, it is our most powerful tool for proactively identifying and mitigating risks before a new system or process goes live.

The FMEA Playbook: A Step-by-Step Guide

A formal FMEA is a rigorous, structured project. While the specific steps can vary, they generally follow this sequence.

Step 1: Select a High-Risk Process and Assemble the Team. You cannot FMEA everything. You must focus your resources on processes that carry the highest risk. Good candidates include: implementing a new technology (e.g., IV workflow software), launching a new clinical service (e.g., meds-to-beds), or using a new high-alert medication. The team must be interdisciplinary, including front-line staff who will actually perform the work, as well as members from other departments who touch the process (nursing, IT, etc.).

Step 2: Create a Detailed Process Map. The team must collaboratively create a high-resolution flowchart of the process as it is intended to function. Every single task, decision point, and handoff must be documented in sequence. A vague or incomplete map will lead to a weak analysis.

Step 3: For Each Process Step, Brainstorm Potential Failure Modes. This is the creative core of the FMEA. For every box in your flowchart, the team asks: “What could go wrong at this step?” or “In what ways could this step fail to produce the intended outcome?” No idea is too small or too unlikely at this stage. The goal is to generate a comprehensive list.

Step 4: For Each Failure Mode, Identify the Potential Effects. If the failure were to occur, what would be the consequences? The effects should be described from the perspective of the patient and the organization. For example, the effect of a dosing error could be “patient receives a toxic overdose, leading to acute kidney injury and prolonged hospitalization.”

Step 5: For Each Failure Mode, Identify the Potential Causes. Why might this failure happen? This involves drilling down to the specific conditions or triggers that could lead to the failure mode. This is where you consider human factors, equipment limitations, and environmental variables.

Step 6: Quantify the Risk with a Risk Priority Number (RPN). This is where the FMEA becomes a powerful analytical tool. The team assigns three numerical scores to each potential failure mode, typically on a scale of 1 to 10.

Severity (S)

How severe is the effect of the failure?

1 = Minor (e.g., slight delay)
10 = Catastrophic (e.g., patient death)

Occurrence (O)

How frequently is the cause of the failure likely to occur?

1 = Extremely Unlikely
10 = Almost Certain to Occur

Detection (D)

How likely are the current controls to detect the failure before it causes harm?

1 = Certain to Detect
10 = Absolutely Undetectable

Risk Priority Number (RPN) = Severity × Occurrence × Detection

The RPN provides a quantitative way to prioritize the risks. A failure mode with an RPN of 700 (e.g., S=10, O=7, D=10) is a much higher priority than one with an RPN of 30 (e.g., S=3, O=2, D=5). The team can then set a threshold (e.g., “We will develop action plans for all failure modes with an RPN > 150”) to focus their efforts.

Step 7: Develop and Implement Action Plans. For the highest-priority risks, the team develops specific actions. The goal of the action is to reduce one of the three scores:

  • – To reduce Severity, you might need to add a rescue pathway or antidote availability. (Often the hardest to change).
  • – To reduce Occurrence, you must address the root cause, often by redesigning the process or adding automation.
  • – To reduce Detection, you must add new checks, balances, or verification steps.

Step 8: Re-evaluate the RPN and Monitor. After the action plans are implemented, the team must go back and re-score the S, O, and D ratings. The goal is to see a significant reduction in the RPN, confirming that the intervention has effectively mitigated the risk. The process is then monitored over time to ensure the new safeguards are working as intended.

Masterclass FMEA: Launching a New “Meds-to-Beds” Program

Below is a truncated example of an FMEA for a new program where a pharmacy technician delivers discharge medications to the patient’s bedside and a pharmacist provides counseling before they leave.

Process Step Potential Failure Mode Potential Effect(s) Potential Cause(s) S O D RPN Recommended Actions New S New O New D New RPN
1. Nurse identifies patient for discharge and notifies pharmacy. Pharmacy is not notified in a timely manner. – Patient discharge is delayed.
– Pharmacy team is rushed.
– Patient dissatisfaction.		 – No standard notification process.
– Nurse forgets to call.
– Call goes to the wrong person.		 4 7 6 168 Integrate an automatic “Ready for Discharge Meds” notification from the EHR to the pharmacy workflow software, triggered by the discharge order. 4 2 2 16
2. Pharmacist reconciles and processes final discharge prescriptions. A home medication is incorrectly continued or a new hospital medication is omitted. – Significant patient harm.
– Hospital readmission.
– Poor clinical outcome.		 – Inaccurate home medication list.
– Rushed reconciliation process.
– Poor communication between medical team and pharmacy.		 9 5 4 180 Implement a mandatory process where a pharmacy technician obtains a best-possible med history on admission, which the pharmacist uses for the final discharge reconciliation. 9 3 2 54
3. Technician delivers filled prescriptions to the patient’s bedside. Wrong patient receives the medications. – Massive patient safety event.
– HIPAA breach.		 – Technician goes to wrong room.
– Two patients with same last name.
– Inadequate patient identification check.		 10 3 8 240 Require the technician to use a mobile scanner to perform a two-point check at the bedside: scan the patient’s wristband barcode AND the barcode on the medication bag. A mismatch creates a hard stop. 10 1 1 10
4. Pharmacist arrives at bedside to provide counseling. Patient has already left the floor. – Critical counseling is missed.
– Patient takes medication incorrectly.
– Non-adherence.		 – Poor coordination between nursing and pharmacy.
– Patient discharged faster than expected.		 7 6 5 210 Create a “Do Not Discharge” flag in the EHR that is placed by the pharmacist when meds are ordered and can only be removed by the pharmacist after counseling is complete. 7 2 2 28

16.3.3 Trend Analysis: Using Past Performance to Predict Future Risk

If FMEA is about predicting the future by analyzing a process map, trend analysis is about predicting the future by analyzing the past. Your medication event reporting system is not just a log of mistakes; it is a rich dataset that, when analyzed correctly, can reveal where your next serious event is brewing. By systematically reviewing aggregate data, you can move from reacting to single events to proactively addressing the patterns they reveal. This is a core function of a Pharmacy Operations Manager and the Medication Safety Officer.

The Power of the Pareto Chart: Focusing on the “Vital Few”

The Pareto principle, or the 80/20 rule, states that for many events, roughly 80% of the effects come from 20% of the causes. In medication safety, this means a small number of error types often account for the majority of reported incidents. A Pareto chart is a simple bar chart that displays the frequency of different categories of events, ordered from highest to lowest, with a line showing the cumulative percentage. It is an incredibly powerful tool for showing your team and hospital leadership where to focus your limited improvement resources.

Pareto Chart: Pharmacy Medication Events Q3
100
50
0

Wrong Dose

Omission

Wrong Drug (LASA)

Wrong Time

Other

Analysis: This chart clearly shows that while we had many types of errors, just three categories—Wrong Dose, Omission, and LASA errors—account for roughly 80% of all reported events. This tells us that instead of launching five different small initiatives, we should focus our resources on a major project to address dose calculation errors (perhaps through CPOE standardization) and LASA drug confusion (perhaps through an FMEA of our drug storage and labeling processes).

Beyond Frequency: Slicing the Data for Deeper Insights

Analyzing raw frequency is just the first step. To truly understand your risks, you must look for patterns by cross-referencing different data fields from your reporting system.

  • Trend Analysis by Location: You run a report and find that 60% of all “Wrong drug in ADC pocket” near misses are coming from the Emergency Department ADC. This is a powerful signal. It tells you there isn’t a hospital-wide problem, but a specific problem with the ED pharmacy workflow, staffing, or ADC configuration. This allows you to launch a targeted investigation.
  • Trend Analysis by Time of Day: Your data shows a significant spike in dispensing errors between 3:00 PM and 5:00 PM every weekday. You realize this corresponds exactly with the afternoon nursing shift change and the time when most discharge orders are being processed. This points to a systems issue of predictable chaos, where interruptions and high workload are leading to errors. Your intervention might be to create a dedicated “discharge pharmacist” role during these hours to manage the volume.
  • Trend Analysis by Drug: You notice that insulin and heparin are involved in 25% of all events that caused patient harm, even though they represent less than 5% of all dispensed doses. This data provides the objective evidence you need to classify them as High-Alert Medications and justify the resources to implement stronger safeguards, such as requiring an independent double-check, using smart pumps with dose-error reduction software, and standardizing concentrations.

16.3.4 Closing the Proactive Loop: From Data to Action

Proactive risk assessment is not an academic exercise. Its only purpose is to drive meaningful change. The FMEA and trend analysis are the diagnostic tools; the resulting quality improvement initiatives are the treatment. As a manager, you must ensure this loop is always closed.

The Danger of “Analysis Paralysis”

It is possible to become so engrossed in data collection and analysis that no action is ever taken. Your role is to balance rigor with pragmatism. A “good enough” analysis that leads to a real, implemented improvement is infinitely more valuable than a “perfect” FMEA that results in a beautiful report that no one ever acts on. Use the data to find the biggest, most obvious opportunities for improvement, and then use the PDSA cycle to start testing solutions quickly.

Your quarterly Medication Safety Committee meeting is the perfect venue to present this work. A powerful presentation might include:

  1. A Pareto chart showing the top 3 error types from the last quarter’s incident reports.
  2. A deeper dive into one of those trends, showing a time-of-day or location-based pattern.
  3. A proposal to charter a formal FMEA to proactively redesign the process identified as highest risk.

By doing this, you are demonstrating a masterful command of both reactive and proactive safety principles. You are showing that you not only learn from past events, but you also use that data to intelligently and strategically predict and prevent future ones. This is the pinnacle of the safety work you began as a pharmacist meticulously checking a single prescription, now applied to protect the entire patient population you serve.