CPIA Interactive Case Studies

CPIA Interactive Case Studies

Certified Pharmacy Informatics Analyst (CPIA)

The Scenario: Complex CDS Rule for Hyperkalemia Prevention

Your hospital's P&T Committee has mandated the creation of a clinical decision support (CDS) rule to prevent hyperkalemia in patients receiving ACE Inhibitors (ACEi) or ARBs. The goal is to create an intelligent alert that targets only the highest-risk patients to avoid contributing to known alert fatigue. As the lead CPIA, you must design and build this rule within the technical constraints of your EHR.

P&T Policy and System Constraints

P&T Policy Requirements

  • Trigger: New order for any ACEi or ARB.
  • High-Risk Co-medications: Active order for Spironolactone, Eplerenone, or any Potassium Supplement (PO/IV).
  • High-Risk Comorbidity: Renal insufficiency, defined as eGFR < 45 mL/min.
  • Action: Alert should recommend baseline and/or follow-up serum potassium (K+) monitoring.

EHR Technical Constraints

  • Can check for active meds and latest lab values.
  • Rules with > 5 "IF-THEN" conditions are discouraged due to system performance impact.
  • Alert text is limited to 200 characters.
  • "Soft" (non-interruptive) and "Hard" (interruptive) alert types are available.

Your Task

1. Design a tiered CDS rule with "soft" and "hard" logic to implement this policy while minimizing low-value alerts.

Answer:

Level 1: Soft, Non-Interruptive Alert

  • IF a new ACEi/ARB is ordered
  • AND Patient's latest eGFR is < 45 mL/min
  • AND Patient does NOT have an active order for a high-risk co-medication
  • THEN display a passive alert suggesting K+ monitoring. This informs the provider of a moderate risk without interrupting workflow.

Level 2: Hard, Interruptive Alert

  • IF a new ACEi/ARB is ordered
  • AND Patient has an active order for Spironolactone, Eplerenone, or a Potassium Supplement
  • AND Patient's latest serum K+ is > 5.0 mEq/L
  • THEN fire an interruptive alert that requires acknowledgement. This targets the most dangerous combination: multiple risk factors plus an existing elevated potassium level.

2. The Nephrology service requests to be excluded from this alert, arguing it's "noise" for them. What is the primary argument for and against this exclusion?

Answer:

  • Argument FOR Exclusion: Excluding specialists can significantly reduce alert fatigue for those expert users, making them more likely to heed other important alerts. They actively manage these electrolyte abnormalities as a core part of their practice, so the alert provides little new value and can be seen as a nuisance.
  • Argument AGAINST Exclusion: It creates a potential safety gap and system inconsistency. A resident or fellow rotating through the nephrology service might lack the specialist's expertise and could benefit from the alert. Furthermore, if a non-specialist places an order on a nephrology patient, the alert would not fire, breaking the safety net. It also adds significant maintenance complexity to the rule.

3. What two key metrics will you use to measure the success of your new CDS rule 30 days after implementation?

Answer:

  1. Alert Acceptance/Override Rate: This is the most critical metric. You will monitor the percentage of time the hard alert is accepted (i.e., the order is modified or canceled) versus overridden. A very high override rate (>90%) indicates the alert is not clinically useful and is causing fatigue. A high acceptance rate suggests it is firing appropriately and changing behavior.
  2. Incidence of Severe Hyperkalemia: The ultimate clinical outcome metric. You will run a report to see if there is a decrease in the incidence of severe hyperkalemia (e.g., K+ > 6.0 mEq/L) in patients on ACEi/ARBs compared to the baseline period before the rule was implemented.

The Scenario: Emergency Smart Pump Library Update

Due to a nationwide shortage of 100mL NaCl bags, your pharmacy must immediately switch to using 250mL bags for intermittent IV antibiotics. Concurrently, your hospital's Medication Safety Committee has mandated adoption of a new ISMP guideline for IV Potassium infusions that requires hard limits. As the CPIA, you must plan and execute an emergency update to the smart pump drug library to address both issues while ensuring patient safety.

Library Details and New Requirements

Current Library Excerpts

  • Drug: Cefepime 2g
    • Concentration: 2g / 100mL
    • Default Rate: 200 mL/hr (30 min infusion)
  • Drug: Potassium Chloride
    • Profile: "IV Drips"
    • Limits: Soft upper rate limit of 20 mEq/hr

New Mandates

  • Pharmacy Shortage: All Cefepime 2g infusions must now be prepared in 250mL NaCl bags.
  • ISMP Guideline: IV Potassium infusions >10 mEq/hr must be administered via a central line and require a hard limit in the pump library.

Your Task

1. Detail the specific changes required for the Cefepime 2g entry to accommodate the bag shortage while maintaining the intended infusion duration.

Answer:

  1. Deactivate Old Entry: The existing "2g / 100mL" concentration must be deactivated (not deleted, to preserve historical data).
  2. Build New Entry: Create a new concentration entry under Cefepime: "2g / 250mL".
  3. Adjust Default Rate: To maintain the 30-minute infusion time, the default rate must be changed. The calculation is: $$250 \text{ mL} \div 0.5 \text{ hours} = 500 \text{ mL/hr}$$. The new default rate should be set to 500 mL/hr.
  4. Update Comments: Add a note in the entry's comments field, e.g., "SHORTAGE CONCENTRATION," to inform the end-user.

2. Design the new, safer Potassium Chloride profile(s) to comply with the ISMP guideline. What is the key safety principle this design enforces?

Answer:

The solution is to create two distinct clinical care areas (profiles) for Potassium:

  • Profile 1: "POTASSIUM - PERIPHERAL"
    • Rate Limit: A HARD limit is set at 10 mEq/hr. The pump will not allow a rate higher than this.
    • Dose Limit: A HARD limit is set at a max dose of 10 or 20 mEq to prevent accidental boluses.
  • Profile 2: "POTASSIUM - CENTRAL LINE"
    • Rate Limit: A HARD limit is set at 20 mEq/hr (or per hospital policy), allowing for higher rates only in monitored settings.
    • Dose Limit: A similar HARD dose limit is applied.

The key safety principle this enforces is differentiation. It forces the nurse to make a conscious clinical choice ("Is my line peripheral or central?") before starting the infusion, guiding them into the appropriate profile with corresponding hard safety limits, rather than relying on a single profile with easily bypassed soft limits.

3. What is the most significant human factors risk when deploying this library, and how can you mitigate it through communication?

Answer:

The most significant human factors risk is improper selection. A nurse, accustomed to the old single potassium entry, might select the "POTASSIUM - CENTRAL LINE" profile out of habit or confusion, even for a patient with only a peripheral line, thereby bypassing the crucial 10 mEq/hr hard limit.

Mitigation Strategy:

Your communication must be direct, clear, and targeted. Create a simple, visual, one-page flyer titled "IV POTASSIUM AND ANTIBIOTIC SHORTAGE UPDATE." Use screenshots from the pump interface to show the new potassium profiles side-by-side. Use clear call-out boxes: "If patient has PERIPHERAL line, you MUST select this," and "If patient has CENTRAL line, select this." For the shortage, show a picture of the new, larger 250mL bag next to the old 100mL bag. Distribute this flyer electronically and post physical copies in medication rooms on every unit the day before the change.

The Scenario: Investigating Anticoagulant Overrides

Your hospital's Medication Safety Officer has flagged a high number of smart pump overrides for continuous heparin infusions. She is concerned that this "override culture" is masking a serious safety risk. She has provided you with a raw data export from the smart pump analytics software for the last quarter and tasked you, the lead CPIA, with performing a deep-dive analysis to identify the root cause and propose a targeted intervention.

Smart Pump Data Export (Last Quarter)

Table 1: Override Summary (N=250)

  • By Shift: Night (7p-7a): 175, Day (7a-7p): 75
  • By Unit: ICU: 120, Med/Surg: 90, ED: 40
  • By Type: Rate/Dose Correction: 150, Soft Limit Alert: 100

Table 2: Soft Limit Alert Details (N=100)

  • Alert Type: 'Rate > Soft Max (2500 u/hr)': 95
  • Unit where 'Rate > Soft Max' Alert Fired:
    • ICU: 90
    • Med/Surg: 5

Table 3: Hospital Protocol Snippet

  • Standard Heparin Protocol: Max rate 2500 units/hr. Used for DVT/PE.
  • ACS/MI Protocol: Requires initial rates often exceeding 3000 units/hr. Used only in ICU/ED.

Your Task

1. Synthesize the data from all three tables. What is the single most specific root cause of the heparin override problem?

Answer:

The root cause is a mismatch between the smart pump library and clinical protocol for a specific indication. The single, standard "Heparin" profile in the pump library has a soft limit of 2500 units/hr, which is appropriate for DVT/PE treatment. However, this limit is too low for patients on the ACS/MI protocol, who are treated almost exclusively in the ICU. This forces ICU nurses to override a clinically inappropriate alert on nearly every ACS patient, accounting for the clustering of "Rate > Soft Max" alerts in the ICU.

2. Explain why this specific pattern represents a major latent safety risk, even if no errors have been reported yet.

Answer:

This pattern creates severe alert fatigue, which is a major latent safety risk. When nurses are forced to repeatedly override an alert they know is clinically inappropriate for their patient population (the ACS patients), they become conditioned to ignore heparin-related alerts. This phenomenon, known as "normalization of deviance," means that when a legitimate alert for a true overdose (e.g., a 10-fold concentration error) appears, they are significantly more likely to override it out of habit, potentially leading to a catastrophic adverse drug event.

3. Propose a specific, informatics-based intervention to address the root cause of the problem.

Answer:

The intervention is to build a separate, indication-specific profile in the smart pump drug library.

  • New Profile: "HEPARIN - ACS Protocol". This profile would be built specifically for the ICU and ED care areas.
  • New Limits: The rate limits in this new profile would be adjusted to match the protocol. For example, a Soft Max of 4000 units/hr and a Hard Max of 5000 units/hr could be set.
  • Standard Profile: The existing "HEPARIN" profile would be renamed "HEPARIN - Standard (DVT/PE)" and its limits would remain the same, but it would be the default choice for Med/Surg floors.

This change eliminates the need for overrides for ACS patients, restoring the value of the alert and ensuring that when it fires, it signifies a true deviation from protocol.

The Scenario: Post-Downtime Data Reconciliation

Your hospital experienced an unexpected, 8-hour EHR downtime overnight. All medication orders and administrations were processed using paper downtime forms. The EHR is now back online, and as the on-call CPIA, you are responsible for leading the pharmacy's data recovery and reconciliation process. Your primary goals are to ensure all patient MARs are accurate, all charges are captured, and any medication discrepancies are identified and resolved before they can cause patient harm.

Downtime Records and System Data

Downtime Log Snippets

  • Patient A (ICU): Paper form shows a new, one-time order for "Vancomycin 1.5g IV" given at 02:00. The order was handwritten by a night resident.
  • Patient B (Med/Surg): Paper MAR shows the 22:00 dose of scheduled warfarin was "held" by the nurse due to a high INR. This was not documented in the EHR before it went down.
  • Patient C (ED): Paper form shows 3 doses of a controlled substance were dispensed from the automated dispensing cabinet (ADC) in override mode.

Pharmacy System Data

  • The EHR's order entry system was unavailable.
  • The pharmacy's dispensing system (which manages inventory) remained online in a stand-alone capacity.
  • The ADCs on the floors were in override mode, allowing medication removal without a verified physician order.

Your Task

1. What is the most immediate patient safety risk upon system recovery, and what is your first priority action?

Answer:

The most immediate risk is duplicate medication administration. A nurse on the next shift might look at the now-active EHR MAR, not see a documented downtime administration, and re-administer a dose that was already given.

First Priority Action:

Your first priority is to direct a team of pharmacists and technicians to immediately begin "back-entering" the paper MARs into the live EHR. This process of retrospectively documenting all administrations that occurred during the downtime is the single most important step to ensure the live MAR is accurate and prevent duplicate doses.

2. For Patient A, the resident's handwritten vancomycin order does not exist in the EHR. What are the three essential steps to reconcile this order?

Answer:

  1. Verify the Order: The pharmacist must contact the resident who wrote the order to confirm its details (dose, route, frequency) and enter it into the EHR as a verbal order. The order must then be verified by the pharmacist in the system.
  2. Document the Administration: Once the order is active, the dose given at 02:00 must be documented on the electronic MAR with a comment like "Given during EHR downtime on [Date] at 02:00."
  3. Charge Reconciliation: Ensure the dose is charged for correctly. Since the order didn't exist, a charge was likely not generated. A manual charge entry is required.

3. What report must you run from the ADC system, and why is it critical for both clinical and regulatory compliance?

Answer:

You must run an override report from the ADC system for the entire downtime period.

Critical Importance:

  • Clinical Compliance: This report is the only way to systematically identify all medications removed without a verified order. Each override must be reconciled against a paper downtime form and a subsequent verified EHR order to ensure the medication was appropriate and documented.
  • Regulatory Compliance: For controlled substances (like with Patient C), this report is an essential legal document. Failure to reconcile every single controlled substance override against a legitimate physician order and a documented administration is a major violation of DEA regulations and can lead to severe penalties.
Return to CPIA Certification Hub