CCPP Module 17, Section 2: Continuous Quality Improvement (CQI) Methodologies
MODULE 17: QUALITY IMPROVEMENT AND OUTCOMES MEASUREMENT

Section 17.2: Continuous Quality Improvement (CQI) Methodologies

A practical introduction to formal QI frameworks like the Plan-Do-Study-Act (PDSA) cycle. Learn how to use these structured methods to test changes, analyze results, and drive systematic improvements in your practice.

SECTION 17.2

From Good Ideas to Great Systems: The Science of Improvement

Applying the scientific method to your clinical practice to achieve predictable, sustainable results.

17.2.1 The “Why”: Moving Beyond “Let’s Try This” to a System of Improvement

As a pharmacist, you are a natural problem-solver. Every day, you engage in informal quality improvement. When a patient’s blood pressure isn’t at goal, you don’t simply refill the same prescription; you investigate. You ask about adherence, side effects, and diet. You might recommend a dose increase, the addition of a new agent, or a change in therapy altogether. You then schedule a follow-up to see if your change worked. This iterative process of assessment, intervention, and reassessment is the scientific method applied to a single patient. It is an informal, small-scale cycle of improvement.

While this approach is perfect for individual patient care, it falls short when you need to improve a process, a workflow, or the outcomes of an entire patient panel. Simply having a “good idea” and implementing it broadly—the “let’s try this and see what happens” method—is fraught with peril. What if the idea doesn’t work? How do you know it was your idea that caused the change, and not something else? What unintended consequences might arise? How do you convince others to adopt your change? To address these challenges, we must move from informal, individual problem-solving to a formal, systematic methodology for improvement. This is the world of Continuous Quality Improvement (CQI).

CQI is not a new or radical concept; it is the rigorous application of the scientific method to how we work. It provides a structured framework for identifying problems, testing potential solutions on a small scale, studying the results, and then deciding whether to adopt, adapt, or abandon the change. It replaces guesswork with data, and opinion with evidence. For the collaborative practice pharmacist, mastering a CQI methodology like the Plan-Do-Study-Act (PDSA) cycle is a superpower. It allows you to take your clinical insights and transform them into durable, scalable, and measurable improvements in care. It gives you a common language to work with nurses, physicians, administrators, and other stakeholders to effect meaningful change. This section will teach you how to become a scientist of your own practice.

Pharmacist Analogy: The Compounding Pharmacist’s Method

Imagine you are a compounding pharmacist tasked with creating a new, more stable formulation of a topical cream. You have a “good idea” that adding a new excipient might improve the shelf life. Do you immediately compound a massive, 10-kilogram batch for the entire pharmacy?

Of course not. That would be reckless, wasteful, and potentially dangerous. Instead, you apply a rigorous, scientific methodology that looks exactly like a CQI cycle:

  • PLAN: You don’t just start mixing. You meticulously plan your experiment. You review the literature. You calculate the exact amount of each ingredient for a small, 100-gram test batch. You define your goal: “Increase stability without affecting texture or absorption.” You predict what will happen: “The addition of 0.5% of Excipient X will increase the beyond-use date by 14 days.” You decide exactly how you will measure success (visual inspection, pH testing, etc.).
  • DO: You execute your plan on a small scale. You compound the 100-gram test batch, carefully documenting every step and any observations.
  • STUDY: You analyze the result. You perform the stability tests you planned. Did the cream separate? Did the pH change? How does it compare to your control batch? You compare your results to your prediction.
  • ACT: Based on your study, you decide what to do next.
    • Adopt: The experiment was a huge success! The cream is more stable and has a perfect consistency. You now create a standard operating procedure (SOP) to scale up production.
    • Adapt: It was partially successful. The stability improved, but the texture is a bit too greasy. You plan a new test cycle (a new PDSA) where you’ll try reducing the excipient concentration to 0.25%.
    • Abandon: The experiment was a failure. The new excipient caused the active ingredient to precipitate out of solution. You discard the idea, document what you learned, and go back to the drawing board to test a completely different approach.

This methodical, small-scale, iterative process is the essence of CQI. You are already trained to think this way about chemistry and pharmacology. You must now apply the same rigor to improving the processes and systems of patient care.

17.2.2 The Engine of Improvement: A Deep Dive into the Plan-Do-Study-Act (PDSA) Cycle

The Plan-Do-Study-Act (PDSA) cycle, also known as the Deming Cycle, is the fundamental engine of most modern quality improvement initiatives. It is an elegant, four-stage scientific method for testing changes in complex systems. Its power lies in its iterative nature and its emphasis on starting small. Rather than betting the farm on a large, untested change, the PDSA cycle allows you to run small, rapid experiments, learn from them, and gradually build toward a robust, evidence-based solution. We will now dissect each phase of the cycle in the detail required for a clinical professional.

The PDSA Cycle

A framework for iterative, scientific improvement.

Systematic
Improvement
PLAN
DO
STUDY
ACT

Phase 1: PLAN – The Blueprint for Change

This is the most critical and often most time-consuming phase. A well-constructed plan is the foundation for a successful test of change. A rushed plan almost guarantees a failed cycle. This phase is about being a meticulous architect before becoming a builder.

Masterclass Table: Deconstructing the “PLAN” Phase
Step Key Question Detailed Actions & Pharmacist Considerations
1. Assemble the Team Who needs to be involved in this change?
  • Go beyond just pharmacists. Think about the entire workflow. If you’re improving the referral process, you need a referring provider (MD/NP/PA), a medical assistant (MA) who rooms the patient, and a front-desk scheduler.
  • Pharmacist Role: You are often the clinical expert and project leader, but you must facilitate a multidisciplinary approach. Ensure every team member feels their expertise is valued.
2. Define the Problem & Aim What are we trying to accomplish?
  • Problem Statement: Clearly and concisely state the problem you are trying to solve. E.g., “Our no-show rate for new patient appointments in the anticoagulation clinic is 25%, leading to wasted capacity and delays in therapy initiation.”
  • SMART Aim Statement: This is your project’s charter. It must be Specific, Measurable, Achievable, Relevant, and Time-bound.
  • Bad Aim: “We will improve the no-show rate.”
  • Good SMART Aim: “We will reduce the no-show rate for new patient appointments in the anticoagulation clinic from 25% to less than 15% within the next 90 days.”
3. Develop a Hypothesis What change do we think will result in an improvement?
  • This is your educated guess, framed as an “if-then” statement. It connects your proposed change to the outcome you expect.
  • Example Hypothesis:If the clinic pharmacist calls every newly referred patient within 24 hours to introduce the service and confirm the appointment, then the no-show rate will decrease because a personal connection builds patient engagement.”
4. Plan the Test (The “5 W’s”) How, exactly, will we run this experiment?

This is the logistics of your small-scale test. Be explicit.

  • Who: Who will carry out the test? (Pharmacist Jane Doe)
  • What: What is the specific change being tested? (A 5-minute introductory phone call using a standard script.)
  • When: When will the test occur? (For one week, starting next Monday.)
  • Where: Where will the test occur? (Only for patients referred from Dr. Smith’s practice.)
  • Why Small?: Starting with one provider’s referrals for one week is a classic small-scale test. It’s manageable and minimizes disruption if it doesn’t work.
5. Plan Data Collection What will we measure, and how?
  • Refer back to your metrics from Section 17.1. What data will prove or disprove your hypothesis?
  • Outcome Measure: The no-show rate for the 10 patients in the test group.
  • Process Measure: Percentage of the 10 patients who were successfully contacted within 24 hours.
  • Balancing Measure: How much time did the phone calls add to the pharmacist’s workload? (This ensures your solution is sustainable).
  • Create a simple data collection sheet *before* you start the “Do” phase.

Phase 2: DO – Executing the Test

This phase is about action. The goal is to carry out the test of change as designed in the planning phase. The key here is adherence to the plan while also being a keen observer of reality. No plan survives first contact with the real world, and the deviations and unexpected events are often where the most valuable learning occurs.

The Power of the Small Test of Change

The single biggest mistake teams make is planning a “Do” phase that is too large. They try to implement a change for all patients, all at once. This is not a PDSA cycle; it is simply “implementation.” The risk of failure is high, and if it fails, the team may become discouraged and abandon the entire project. The mantra of CQI is to start small.

Think in terms of “The Power of One”:

  • Test the change with one patient.
  • Test the change with one provider.
  • Test the change for one hour or one afternoon.
This allows for rapid learning with minimal risk. If it fails, you’ve only invested a small amount of time and effort. You can quickly adapt and try again. This rapid, iterative approach is how you build momentum and confidence.

During the “Do” phase, your primary responsibilities are:

  • Carry out the change: Follow the protocol you designed in the “Plan” phase as closely as possible.
  • Collect the data: Use the data collection sheet you created. Record the quantitative measures (the numbers) diligently.
  • Be an anthropologist – observe and document: This is just as important as collecting the numbers. Keep a log. What worked well? What was awkward? What problems did you encounter that you didn’t anticipate? For our no-show example, you might note: “Three out of ten patients didn’t answer the phone. Had to leave a voicemail. Is that as effective?” or “Dr. Smith’s MA was confused about the new process and forgot to flag a referral for me.” This qualitative data is gold.

Phase 3: STUDY – Analyzing the Results

In this phase, you put on your data analyst hat. The goal is to turn the raw data and observations from the “Do” phase into knowledge. This involves analyzing the data, comparing it to your predictions, and summarizing what you’ve learned.

Key activities in the “Study” phase:

  • Aggregate your data: Compile the numbers from your data collection sheet. For our example:
    • Outcome: “Of the 10 patients in the test group, only 1 was a no-show. This is a 10% no-show rate, compared to our baseline of 25%.”
    • Process: “We successfully contacted 7 of the 10 patients (70%) within 24 hours. The other 3 received voicemails.”
    • Balancing: “The calls took an average of 6 minutes per patient, for a total of one hour of pharmacist time.”
  • Compare results to predictions: Did what happened match what you expected to happen? “Our hypothesis was that the calls would reduce no-shows, and they did. The rate dropped from 25% to 10% in our small sample.”
  • Analyze the qualitative data: Review your observation log. “The learning that voicemails may be less effective and that the MA workflow needs to be clearer are critical findings.”
  • Summarize the learnings: Synthesize everything into a few key takeaways. “The personal phone call appears to be a highly effective intervention. However, we need a better process for patients we can’t reach directly, and we must provide better training for the MAs to ensure the workflow is reliable.”

Phase 4: ACT – Deciding What’s Next

Based on what you learned in the “Study” phase, the team must now make a decision. This is not simply a “pass/fail” judgment. There are three distinct paths you can take, and each one represents progress.

Adopt

The change was successful and resulted in a clear improvement. The team decides to adopt the change and plan for a broader implementation. This might involve expanding the test to more providers, standardizing the workflow, and creating training materials. The goal is to make the successful change the new standard process.

Adapt

The change was partially successful, or it revealed new problems or opportunities for improvement. The team decides to adapt or modify the change. This immediately leads to a new PDSA cycle. For our example, the team might say, “Let’s adapt our plan. In the next cycle, we’ll test a process that includes sending a text message to patients who don’t answer the phone.”

Abandon

The change did not lead to an improvement, or it had significant negative consequences. The team decides to abandon this specific idea. This is NOT a failure. It is a success in learning. The team has successfully proven that a particular hypothesis was incorrect, saving them from implementing a useless or harmful change on a large scale. They document what they learned and return to the “Plan” phase to develop a new hypothesis.

17.2.3 Foundational QI Tools: Seeing the Problem Clearly

To effectively “Plan” a test of change, you first need a deep understanding of your current state. Two foundational QI tools are invaluable for this: Process Mapping, to visualize your workflow, and Cause-and-Effect Diagrams, to brainstorm the root causes of a problem.

Visualizing the Workflow: Process Mapping (Flowcharts)

You can’t fix a process you don’t understand. A process map, or flowchart, is a simple visual tool that lays out all the steps, decision points, and handoffs in a workflow. The act of creating the map with your team is often enlightening, revealing hidden complexities, redundancies, and bottlenecks that no single person was aware of. It’s the equivalent of drawing out a complex biochemical pathway to understand where a drug exerts its effect.

Example: Process Map for New Patient Scheduling
Start: Referral Placed
Referral enters Pharmacist’s EHR inbox
Pharmacist reviews chart for appropriateness
Decision: Is all necessary info present (labs, diagnosis)?
Yes No
WASTE: Pharmacist messages provider for more info
DELAY: Wait for provider response (1-3 days)
Pharmacist forwards referral to scheduler
Scheduler calls patient to make appointment
End: Patient Scheduled

By mapping this out, the team can immediately see a major source of delay: the back-and-forth communication to get missing information. This becomes a prime target for a PDSA cycle (e.g., “Let’s test a new, standardized referral template that requires all necessary information upfront”).

Brainstorming Root Causes: The Fishbone Diagram

Once you’ve identified a problem, you need to understand its root causes. The Cause-and-Effect Diagram, also known as a Fishbone or Ishikawa Diagram, is a structured brainstorming tool that helps teams think through all the potential reasons for a problem. The “head” of the fish is the problem statement, and the “bones” represent categories of potential causes.

Masterclass Table: Fishbone Diagram Categories & Pharmacy Examples

Problem: High Patient No-Show Rate

Category (“Bone”) Description Potential Causes for High No-Show Rate
People Factors related to staff, providers, or patients.
  • Patient forgot the appointment.
  • Patient doesn’t understand the purpose of the visit.
  • Scheduler sounds rushed or unfriendly on the phone.
  • Provider did not effectively explain the reason for the referral.
Process Factors related to the sequence of steps or workflow.
  • Long wait time between referral and appointment date.
  • No appointment reminder system in place.
  • Complex or confusing scheduling process.
  • Appointments are not confirmed with the patient.
Technology/Tools Factors related to equipment, software, and tools.
  • Automated reminder system is sending texts to wrong numbers.
  • EHR scheduling system is difficult to use.
  • Patients are not given appointment cards.
Environment Factors related to the physical location and external environment.
  • Clinic location is hard to find or has poor parking.
  • Patient lacks reliable transportation.
  • Appointment times conflict with work or childcare obligations.
  • Bad weather on the day of the appointment.

By brainstorming causes in these categories, the team can identify multiple potential areas for intervention and prioritize which ones to test first with a PDSA cycle.