CASP Module 17, Section 2: PDSA, RCA, and CAPA Methodologies
MODULE 17: MASTERING QUALITY, COMPLIANCE, AND ACCREDITATION

Section 2: PDSA, RCA, and CAPA Methodologies

Master the core tools of quality improvement: Plan-Do-Study-Act (PDSA) cycles for iterative improvement, Root Cause Analysis (RCA) for investigating errors, and Corrective And Preventive Actions (CAPA) for implementing lasting solutions.

SECTION 17.2

PDSA, RCA, and CAPA Methodologies

The Pharmacist’s Toolkit for Building a Self-Correcting Quality System.

17.2.1 The “Why”: The Engine of a Quality Management System

In Section 17.1, we created our blueprint. We took the massive, intimidating accreditation manual and, through a Gap Analysis, turned it into a prioritized Roadmap. We identified all the “gaps” between our current practice and the “best practice” standard. Now what? That roadmap is just a list of “to-do”s. This section provides the tools to do them. This is the “how-to” for fixing what’s broken and improving what works.

If your Quality Management System (QMS) is a car, the Gap Analysis was the diagnostic check. What you’re about to learn—PDSA, RCA, and CAPA—is the engine. These methodologies are the active, dynamic processes you will use every single day to power your pharmacy’s improvement. Accreditation bodies like URAC and ACHC don’t just want to see that you fixed your gaps; they demand to see the process you used to fix them. They want to see that you have a self-correcting system that can not only solve today’s problems but can also identify and prevent tomorrow’s.

As an experienced pharmacist, you are already an intuitive master of these concepts. You just use different names for them.

  • When a patient’s adherence is poor, you don’t just note it. You (P)lan an intervention (e.g., “switch to bubble packs”), (D)o it, (S)tudy the result next month, and (A)ct by continuing it. That is a PDSA cycle.
  • When a dispensing error occurs, you don’t just fix the script. You stop and ask, “Why did this happen?” (e.g., “The bottles look alike and are stored together.”). That is a Root Cause Analysis (RCA).
  • After finding the root cause, you (C)orrect the error (e.g., “call the patient”) and take (P)reventive action (e.g., “move one drug and add a ‘LASA’ sticker”). That is a CAPA.

This section is not about teaching you a new skill. It is about taking your innate, clinical problem-solving process and making it formal, documented, measurable, and repeatable. This is the fundamental difference between a good pharmacist and an accredited Certified Advanced Specialty Pharmacist. You don’t just do quality; you manage it.

Pharmacist Analogy: From Home Cook to Executive Chef

As a community pharmacist, you are an excellent “home cook.” A patient (a “customer”) comes in with a prescription (an “order”). You use your skill to “cook” it—you verify the dose, check interactions, and dispense it. If you make a mistake (e.g., you “over-salt the dish”), you taste it (DUR check) or the customer complains, and you fix it on the spot. It’s a reactive, individual-based process. You are the hero.

An accredited specialty pharmacy is a high-end restaurant, and you are the “Executive Chef” running a “Michelin-star kitchen.” You don’t just cook. You design systems so that every dish is perfect, every time, no matter who is cooking.

PDSA (Plan-Do-Study-Act): This is your “Test Kitchen.” You want to improve a dish (a “process”), like your “Oncology Patient Onboarding.” You don’t just change the whole menu. You (P)lan a small change (e.g., “a new welcome script”). You (D)o it for one day on one table (a “small-scale test”). You (S)tudy the feedback (“the script was confusing”). You (A)ct by adapting the script and running the test again. This is iterative improvement.

RCA (Root Cause Analysis): A customer gets a raw dish (a “medication error”). You don’t just fire the line cook (“human error”). You perform an RCA. You ask the “5 Whys.” Why was it raw? “The cook misread the ticket.” Why? “The printer ink was low.” Why? “There’s no P&P for checking the ink.” Why?… The Root Cause wasn’t the cook; it was a failed maintenance process.

CAPA (Corrective and Preventive Actions): This is your documented fix. The (C)orrective Action is “comping the meal and re-firing the dish” (calling the patient and dispensing the right drug). The (P)reventive Action is “creating a new opening checklist for the line cook that includes ‘Check printer ink’ and buying a new printer with a ‘low ink’ alert.” You’ve made the system safer. This is the essence of a QMS.

17.2.2 Masterclass: PDSA (Plan-Do-Study-Act) for Iterative Improvement

The PDSA cycle is the engine of Continuous Quality Improvement (CQI). It is the scientific method, simplified for the workplace. It’s designed to test a change on a small scale before implementing it broadly, which saves you from launching a new, untested idea across the entire pharmacy and watching it fail spectacularly. You will use PDSA to close the gaps you found in your Gap Analysis, especially those related to inefficient processes.

The Goal: To test a change quickly, learn from the results, and adapt. The key is to run rapid, small cycles. You might run 3-4 PDSA cycles in a single week to perfect a new workflow.

The Four Stages of the PDSA Cycle

Let’s break down each step with the precision of a pharmacist.

PLAN

This is 90% of the work. A good plan makes the rest of the cycle easy. A bad plan guarantees failure.

  • Define the Objective: What is the *exact* problem you are trying to solve? (e.g., “Our patient intake process takes too long.”)
  • Set a SMART Goal: Specific, Measurable, Achievable, Relevant, Time-bound. (e.g., “Reduce the average time from referral receipt to patient contact from 24 hours to 4 business hours within 60 days.”)
  • Formulate a Hypothesis: What change do you predict will work? (e.g., “We predict that creating a dedicated ‘Intake Tech’ role will streamline the process.”)
  • Plan the Test (The “DO”):
    • Crucial: Make it SMALL. Not “Let’s hire a new tech,” but “Let’s have Technician A act as the dedicated Intake Tech for one day.”
    • Who will be involved? (Tech A and RPh B)
    • When will it happen? (Next Tuesday, 9am-5pm)
  • Plan the Data (The “STUDY”): How will you know if it worked? You need data!
    • Quantitative: “We will log the ‘Referral-In’ and ‘Patient-Contact’ times for all of Tech A’s referrals.”
    • Qualitative: “We will interview Tech A and RPh B at the end of the day for their feedback.”

DO

This is the simplest step. You just execute the small-scale test you designed in the “Plan” phase.

  • Execute the test: Tech A performs the dedicated Intake Tech role for the day.
  • Collect the data: You (the pharmacist lead) log the times on your spreadsheet.
  • Document problems: What went wrong? (e.g., “The fax machine ran out of paper, delaying 3 referrals.” “Tech A was pulled away to help counting.”)
  • Stick to the plan: Resist the urge to change the test mid-stream. Let it run as planned, even if you see problems. That’s what the “Study” phase is for.

STUDY

This is the “analysis” phase. You compare your results to your prediction.

  • Analyze Quantitative Data: “Our goal was 4 hours. The average time for Tech A’s 20 referrals was 3.5 hours. This is a success! However, 3 referrals were delayed by the fax machine.”
  • Review Qualitative Data: “Tech A reported feeling ‘less stressed’ and ‘more efficient.’ RPh B reported that the handoffs were ‘much cleaner’ and the data was more complete.”
  • Compare to Prediction: “Our hypothesis that a dedicated tech would speed up the process appears to be correct.”
  • Summarize Learnings: What did you learn? “A dedicated role works, but it is vulnerable to physical (fax) and staffing (being pulled away) disruptions.”

ACT

Based on what you learned, you make a decision. This decision is *always* one of three things:

  • Adopt: “The change was a 100% success. Let’s make this the new, permanent P&P and train all techs on the ‘Intake Tech’ rotation.” (This is rare on the first cycle).
  • Adapt: “The change was a partial success. It worked, but we have new problems.” This is the most common outcome. Your “Act” is to go back to the PLAN phase for Cycle 2.
    • New PLAN (Cycle 2): “Our goal is to protect the new role. We will test having a *dedicated backup* tech and moving to an *e-fax system*.”
  • Abandon: “This was a disaster. The dedicated tech became a bottleneck, and times increased. This idea is dead.” Go back to the PLAN phase with a completely new hypothesis.

Tutorial: A Multi-Cycle PDSA for a Clinical Pharmacy Gap

Let’s walk through a complex, multi-cycle PDSA to solve a common and critical accreditation gap: “Pharmacist clinical assessment documentation is inconsistent and incomplete.”

The Problem: Your Gap Analysis (Tracer Audit) found that pharmacists are doing clinical reviews, but they are not documenting them in a standardized way. Some write a free-text note, some write nothing, some use abbreviations. A surveyor cannot “see” the clinical work being done.

SMART Goal: Achieve 95% compliance in completing a new, standardized “Pharmacist Clinical Assessment Note” for all new specialty patients within 90 days.

PDSA Cycle 1: The Paper Test
  • PLAN:
    • Hypothesis: A simple paper checklist form will be the fastest way to get buy-in and test the required fields.
    • Test: The Pharmacist Lead (you) will draft a 1-page “Clinical Assessment Checklist” on paper.
    • Small Scale: One pharmacist (RPh A) will use this paper form for 5 new patients on one afternoon.
    • Data: 1) The 5 completed forms. 2) RPh A’s qualitative feedback on the form’s workflow.
  • DO: RPh A uses the paper form for 5 patients. They have to print 5 copies, fill them out by hand, and then scan them into the patient’s profile.
  • STUDY:
    • Data: The 5 forms are 100% complete. All required fields (DDI check, adherence assessment, side effect counseling) are documented. This is a success.
    • Feedback: RPh A says, “This is a nightmare. The form is great, but printing, filling, and scanning added 10 minutes per patient. I’ll never keep this up.” This is a failure.
  • ACT: (ADAPT)
    • Learning: The *content* of the form is good, but the *workflow* (paper) is a critical failure.
    • New Plan (Cycle 2): We must build this form *inside* the pharmacy system.
PDSA Cycle 2: The EMR Build Test
  • PLAN:
    • Hypothesis: Building the checklist as a “smart form” or “template” within the EMR will make it fast and easy for pharmacists to complete.
    • Test: Work with IT to build the checklist as a clickable form inside the EMR.
    • Small Scale: Two pharmacists (RPh A and RPh B) will use the new EMR form for one day.
    • Data: 1) The completed EMR notes. 2) The average *time* it took (e.g., click logs). 3) Feedback from RPh A and RPh B.
  • DO: The two pharmacists use the new EMR form.
  • STUDY:
    • Data: 18 of 20 notes were completed (90% compliance). Success!
    • Feedback: RPh A: “I love it, it’s fast.” RPh B: “It’s good, but it’s missing a free-text box for ‘Other Clinical Concerns.’ I had to write a separate note for a complex case.” RPh B also noted, “The form is not ‘required,’ so I forgot it twice.”
  • ACT: (ADAPT)
    • Learning: The EMR form is the right solution, but it needs two tweaks: a free-text box and a “forcing function” to ensure it’s not missed.
    • New Plan (Cycle 3): We will make two small IT changes.
PDSA Cycle 3: The “Final” Polish
  • PLAN:
    • Hypothesis: Adding a free-text box and making the form a “hard stop” will get us to 100% compliance without frustrating users.
    • Test: IT adds the free-text box. IT makes the form a “required field” that must be completed before the pharmacist can verify the prescription.
    • Small Scale: All 5 specialty pharmacists will use the final form for one week.
    • Data: 1) Compliance rate. 2) Feedback from all 5 pharmacists.
  • DO: All 5 RPhs use the form for a week.
  • STUDY:
    • Data: 120 of 120 new patient assessments were completed (100% compliance!).
    • Feedback: All pharmacists agree the form is fast, comprehensive, and the “hard stop” is a good reminder.
  • ACT: (ADOPT)
    • Learning: The change is a 100% success.
    • Action: This is now our new, permanent workflow. We will update the P&P, finalize the training, and close this gap on our Gap Analysis tool.
Common PDSA Pitfalls (How to Fail)

Pharmacists, who are trained to be perfect, often make these common mistakes with PDSA.

  • The “Boil the Ocean” Test: Your “Do” phase is too big. (e.g., “Let’s train all 20 staff on the entire new system all at once!”). This is not a “test”; it’s a full-scale, high-risk implementation. If it fails, you’ve disrupted the whole pharmacy. Solution: Always test with one person, one drug, one day. Make the test so small it’s almost impossible to fail.
  • The “Data-Free” Cycle: You rely on *feelings*. “How did the new script feel?” “I think it was better.” This is useless. You have no idea if you met your goal. Solution: Always define a *measurable*, *quantitative* metric in your “Plan” phase (e.g., “call time in seconds,” “number of clicks,” “error rate”).
  • The “Plan-Do, Plan-Do” Cycle: You skip the “Study” and “Act” steps. You have an idea (Plan), you try it (Do), and it doesn’t quite work, so you immediately try something else (new Plan). You are just “tinkering.” You never stop to analyze *why* it failed. Solution: Force your team to have a formal “Study” meeting. Look at the data and write down “What did we learn?” *before* you plan the next cycle.

17.2.3 Masterclass: RCA (Root Cause Analysis) for Investigating Errors

If PDSA is your tool for proactive improvement, Root Cause Analysis (RCA) is your tool for reactive investigation. An RCA is a formal, structured process for investigating a “sentinel event,” a “medication error,” or a “near miss.” Its purpose is to move beyond what happened and who did it, to understand why it was possible for it to happen in the first place.

Accreditation bodies (especially TJC and URAC) are obsessed with RCAs. They *require* you to have a P&P for conducting them. When a surveyor finds an error, their first question will be, “Show me the RCA you performed for this.”

The Single Most Important Concept: Proximate Cause vs. Root Cause

This concept is the key to unlocking a culture of safety. Failing to understand this is the #1 reason RCAs fail.

  • Proximate Cause (The “What”): This is the *immediate* cause of the error. It is almost always a “human error.”
    • Example: “The pharmacist, RPh Joe, verified the prescription for hydrALAZINE 25mg instead of hydrOXYzine 25mg.”
  • Root Cause (The “Why”): This is the *system failure* that made the human error inevitable or, at best, likely.
    • Example: “The pharmacy’s electronic shelf is alphabetical, placing hydrALAZINE and hydrOXYzine in adjacent bins. Both are made by the same manufacturer, in identical white bottles with blue caps. The system does not have ‘Tall Man’ lettering.”
The Blame Game: Why “Human Error” is a Failed RCA

A true “blameless” RCA assumes that the pharmacist (RPh Joe) is a trained, competent, and well-intentioned professional. He did not want to make an error. The system set him up to fail.

If your RCA concludes with: “Root Cause: RPh Joe was not paying attention,” you have FAILED your RCA. You have learned nothing, and you are guaranteed to have the *exact same error* happen again when another pharmacist is similarly “not paying attention.”

Your “fix” (Preventive Action) for “RPh Joe wasn’t paying attention” is “Tell RPh Joe to pay more attention” or “Re-train RPh Joe.” This is the weakest possible fix. A true, system-based fix for the *real* root cause would be: “Separate the drugs on different shelves,” “Purchase from a different manufacturer,” or “Enable ‘Tall Man’ lettering.” These fixes protect *all* pharmacists, forever.

A culture of safety is not one where no one makes errors; it’s one where the system is designed to *catch* and *absorb* inevitable human errors before they reach a patient.

RCA Methodology 1: The “5 Whys” (The Quick and Powerful Tool)

This is the simplest and most common RCA tool. You start with the problem (the Proximate Cause) and, like a 2-year-old, you just keep asking “Why?” until you can’t anymore. The final “Why?” often reveals the broken system or process.

Tutorial: A “5 Whys” RCA for a Cold-Chain Failure

The Incident: A new Humira patient calls. Their $5,000 medication arrived, and the ice packs were melted and the box was warm.

  • 1. Why did the patient receive a warm drug?
    • Answer: Because the ice packs melted before the package arrived.
  • 2. Why did the ice packs melt?
    • Answer: Because the package was in transit for 72 hours, but the cooler was only rated for 48 hours.
  • 3. Why was a 48-hour cooler used for a 72-hour shipment?
    • Answer: Because the tech, “Tech B,” didn’t realize it would take 72 hours. He thought it was a 2-day delivery.
  • 4. Why did Tech B think it was a 2-day delivery?
    • Answer: Because the patient lives in a “rural” zip code, which our courier (FedEx) only services on M/W/F. The order was shipped on Monday, so it sat in a warehouse until Wednesday. Tech B didn’t know this. (This is a training/process gap).
  • 5. Why didn’t Tech B know about the rural zip code rule?
    • Answer: Because our shipping P&P, #7.3, doesn’t have a zip code look-up table, and our shipping software doesn’t warn us about 3-day deliveries. (This is the ROOT CAUSE: A failed process and a failed technology).

Look at the difference:

Failed RCA (Proximate Cause): “Tech B made a mistake.” Fix: “Re-train Tech B.” (What about Tech C, D, and E?)

Successful RCA (Root Cause): “Our shipping process and software lack the critical controls to prevent shipping non-validated packages to rural zip codes.” Fix: “1. Update P&P #7.3 with a rural zip code lookup. 2. Get a new shipping software module that validates delivery dates against our cooler validation.”

RCA Methodology 2: The Fishbone (Ishikawa) Diagram

The “5 Whys” is great for simple, linear problems. But what about a *complex* failure, where 10 different things went wrong? For this, you need a tool that can organize many different causes. The Fishbone Diagram is a visual tool for brainstorming and categorizing all the *potential* causes of a problem.

You draw a “head” (the problem) and a “spine.” Then you draw “bones” coming off the spine, which are your main categories. You and your RCA team then brainstorm causes and add them to the correct “bone.”

Tutorial: A Fishbone Diagram for a “New Oncology Patient First-Dose Delay”

The Incident (The “Head”): A new, high-priority oncology patient’s first dose of Ibrance was delayed by 5 days.

Cause Matrix: Oncology First-Dose Delay

PROBLEM
Ibrance first dose delayed 5 days
People
  • Intake tech was new, not fully trained on “STAT” orders.
  • PA tech was on vacation; no one covered their queue.
  • Pharmacist assumed PA was “in progress” and didn’t follow up.
  • Patient was “not available” for first contact call.
Human Factors
Technology (Systems)
  • e-Fax referral came in as “low quality” and was unreadable.
  • EMR “PA Required” flag did not fire for this drug.
  • No automatic alert/timer for “STAT” orders in the queue.
  • Patient’s voicemail box was full.
IT & Tools
Process
  • P&P for “STAT” order handling does not exist.
  • No handoff process for PA queue when tech is on vacation.
  • No P&P defining call attempt count before stopping.
  • No formal “First-Dose Welcome Call” script.
Workflow
Materials / External
  • Prescriber sent incomplete referral (missing chart notes).
  • PBM required a 72-hour review period for the PA.
  • Drug not in stock; special order required (24h delay).
Outside Inputs

By dumping all these causes into categories, you can now see that this was a total system failure. The “Root Causes” are not just one thing. They are: 1) A lack of a formal “STAT Order” P&P, 2) A lack of a “PA Handoff” P&P, and 3) A technology failure (no STAT alert). You now have clear, high-priority targets for your CAPA.

17.2.4 Masterclass: CAPA (Corrective and Preventive Actions)

The RCA is the *investigation*. The CAPA is the *solution*. This is the formal, documented action plan you create to respond to your RCA’s findings. This is, without question, one of the most important documents in your entire QMS. An accreditation surveyor will absolutely ask to see your “completed CAPA forms” for any errors you’ve reported.

A CAPA has two distinct parts that must not be confused. Failing to separate them is a common mistake.

Corrective Action (CA) vs. Preventive Action (PA)

  • Corrective Action (CA): The “Firefighting”
    • Definition: The immediate, reactive steps you take to fix the *single error* that just happened and help the specific patient(s) affected.
    • Goal: To contain the damage.
    • Example (for the “Warm Humira” RCA):
      1. Called the patient, instructed them to discard the warm drug.
      2. Notified the prescriber of the incident and the delay.
      3. Dispensed and shipped a replacement drug overnight (using a *validated* shipper this time).
  • Preventive Action (PA): The “Fireproofing”
    • Definition: The systemic, proactive changes you make to fix the *root cause* (which you found in your RCA) so that this error *can never happen again*.
    • Goal: To re-design the system.
    • Example (for the “Warm Humira” RCA):
      1. Revised P&P #7.3 (Cold Chain) to *require* use of validated 72-hour coolers for all rural zip codes.
      2. Created a “Rural Zip Code” lookup list and posted it at the shipping station.
      3. Held a mandatory training for all 4 shipping techs on the new P&P.
      4. (Stronger action): Integrated the courier’s software to provide a “delivery date guarantee” on the shipping screen *before* the tech can print the label.

You can see the difference. The CA helped one patient. The PA helps *all future patients*.

Tutorial: Creating the “CAPA Form” (Your Most Important Document)

Every accredited pharmacy must have a blank “CAPA Form” (or an electronic equivalent). This is the template you pull out every time an RCA is completed. Here is a masterclass in what that form must contain.

Playbook: The Anatomy of a Bulletproof CAPA Form

This is your official record. It must be clear, detailed, and assign accountability.

CAPA Form: [Specialty Pharmacy Name]
CAPA ID: (e.g., CAPA-2025-004) Date Opened: 10/25/2025
1. Incident Description: (What happened?)

Patient R.K. in zip code 12345 (rural) received Humira shipment (Order #123456) on 10/24. Patient reports ice packs were melted and drug was warm.

2. Related RCA: (Link to the investigation)

RCA-2025-003 (“5 Whys”)

3. Root Cause(s) Identified: (What did the RCA find?)

  • Root Cause 1: Shipping P&P #7.3 is based on “2-Day” shipping but does not account for rural zip codes that have 3-day+ service.
  • Root Cause 2: Shipping software does not provide a *guaranteed delivery date* to the tech at the time of processing.

4. Corrective Actions (CAs): (How we fixed it for *this patient*)
ActionAssigned ToDate DueDate Done
1. Call patient, instruct to discard, apologize.RPh-Lead10/2510/25
2. Notify prescriber of delay and re-ship.RPh-Lead10/2510/25
3. Re-dispense & ship (in validated 96-hr cooler).Ops-Lead10/2510/25
5. Preventive Actions (PAs): (How we will fix it for *all patients*)
ActionAssigned ToDate DueDate Done
1. Revise P&P #7.3 to include a “Rural/3-Day Zip Code List.”Q-Mgr11/01
2. Post this list at all shipping stations.Ops-Lead11/02
3. Train all 4 shipping techs on new P&P #7.3. (Document in training file).Ops-Lead11/05
4. Contact shipping software vendor to request “Delivery Date Guarantee” feature.IT-Lead11/15
6. Validation & Follow-Up: (How we will *prove* the fix worked)

Quality Manager will perform a weekly audit of 5 random cold-chain shipments to rural zip codes to ensure P&P #7.3 is being followed. Audit will run for 4 weeks. Report to be presented at next QMC meeting.

CAPA Closed By: [Quality Manager] Date Closed: [e.g., 12/15/2025]

Weak vs. Strong Preventive Actions: A Masterclass

Not all Preventive Actions are created equal. This is a high-level concept that surveyors *love* to see. The strength of your action is based on how much it relies on a human *remembering* to do the right thing.

Strength Action Type Example (for LASA Error) Why it’s Weak/Strong
WEAKEST Policies & Training “Re-train all pharmacists on the LASA P&P.”
“Tell pharmacists to ‘be more careful’.”
Relies 100% on human memory and vigilance. It is the weakest possible fix and is guaranteed to fail again. A surveyor will find this “insufficient.”
MEDIUM Checklists & Reminders “Add ‘LASA’ stickers to the bins.”
“Add a checklist to the fill process.”
Better. This is a *cognitive aid*. It provides a reminder at the point of the error. However, a human can still ignore the sticker or “pencil-whip” the checklist.
STRONG System Re-Design “Separate hydrALAZINE and hydrOXYzine to different aisles in the pharmacy.” Strong. You have changed the physical environment to make the error more difficult. The pharmacist would have to walk to a completely different location.
STRONGEST Forcing Function / Hard Stop “Implement barcode scanning. The system will *not allow* the prescription to be verified if the bottle’s barcode does not match the drug in the profile.” The ultimate fix. The system makes it *impossible* to make the error. This requires no human vigilance or memory. This is the goal of all high-level quality improvement.

17.2.5 Putting It All Together: The Virtuous Cycle of Quality

It’s critical to understand that PDSA, RCA, and CAPA are not three separate, independent tools. They are one single, interconnected engine that powers your entire QMS. You will flow between them naturally, every single day.

This diagram shows how they feed into each other to create a “Virtuous Cycle” of continuous quality improvement. This is the living, breathing system that accreditation bodies want to see.

The Virtuous Cycle of Quality Management

1. YOUR STANDARD PROCESS (Baseline)

This is your “day-to-day” workflow (e.g., Patient Intake, Dispensing, Shipping). It is stable.

2. A “QUALITY EVENT” OCCURS

One of two things happens…

A: PROACTIVE IMPROVEMENT

You identify an opportunity or inefficiency. (e.g., “Our intake is too slow,” “We should improve our adherence counseling.”)

You use: PDSA CYCLE

You (P)lan, (D)o, (S)tudy, and (A)ct on a small-scale test to improve the process.

B: REACTIVE INVESTIGATION

An error, near miss, or patient complaint occurs. (e.g., “Wrong drug,” “Warm shipment,” “LASA error.”)

You use: RCA

You perform a Root Cause Analysis to find the system failure (e.g., “5 Whys”).

You use: CAPA

You document the (C)orrective and (P)reventive actions to fix the root cause.

3. A NEW, IMPROVED PROCESS IS CREATED

The “Act” from your PDSA (e.g., “the new EMR form”) or the “Preventive Action” from your CAPA (e.g., “the new shipping P&P”) becomes your new standard process.

…and the cycle repeats, forever. This is Continuous Quality Improvement (CQI).

As a Certified Advanced Specialty Pharmacist, you are the leader of this entire cycle. You are the one who identifies the opportunities for PDSAs. You are the one who leads the blameless RCAs. And you are the one who designs the strong, system-based Preventive Actions for the CAPAs. You are not just a dispenser of medications; you are the chief quality engineer for your entire pharmacy practice.