CASP Module 17, Section 5: Post-Accreditation Maintenance & Renewal
MODULE 17: MASTERING QUALITY, COMPLIANCE, AND ACCREDITATION

Section 5: Post-Accreditation Maintenance & Renewal

Understand the requirements for maintaining accreditation status between surveys, including ongoing data submission, policy updates, and preparing for successful re-accreditation cycles.

SECTION 17.5

Post-Accreditation Maintenance & Renewal

From “Project Complete” to “Perpetual Readiness”: The Marathon of Maintenance.

17.5.1 The “Why”: Accreditation is a License, Not a Trophy

You and your team have just completed a marathon. For the last 12 to 18 months, you have lived and breathed accreditation. You led the Gap Analysis (Sec 17.1), built the QMS Engine (Sec 17.2-17.3), and ran your first Internal Audits (Sec 17.4). The surveyor came, you passed, and the plaque is now on the wall. The entire pharmacy breathes a collective sigh of relief and thinks, “Thank goodness that’s over. Now we can get back to real work.”

This is the single most dangerous moment in your quality journey.

Accreditation is not a trophy you win. It is a license you earn. It is not a one-time project; it is a three-year process that begins the moment the surveyor walks out the door. The initial accreditation was just the “application.” The maintenance phase is the “job.” Your task now is to prove that the QMS you built was not just “for show,” but that it is a living, breathing part of your pharmacy’s DNA. Your goal is to move from the stressful, cyclical “panic-and-prepare” model to a state of “Continuous Readiness.”

Why? Because the re-accreditation survey is fundamentally different from the initial one.

  • On your Initial Survey, the surveyor asks: “Show me your policy that says you will do this.” (e.g., “Show me your P&P for handling complaints.”)
  • On your Renewal Survey, the surveyor asks: “Show me the proof that you have been doing this for the last 3 years.” (e.g., “Show me your complaint logs for Q2 2024,” “Show me the QMC meeting minutes where you trended that complaint data,” and “Show me the CAPA you generated from that trend.”).

Without a robust maintenance program, you will have no proof. You will have a three-year gap in your documentation, and you will fail your renewal survey. This is a catastrophic, high-stakes business failure. It means PBMs and payers will drop you from their networks, and your specialty pharmacy may cease to be viable.

This section is the masterclass on how to build that maintenance program. It is the capstone of your QMS. We will cover the three pillars of maintenance: the ongoing data you must submit, the P&Ps you must keep alive, and the process for managing the renewal cycle. This is how you prove that your commitment to quality is not a project, but your entire culture.

Pharmacist Analogy: The Formula 1 Racing License

Your journey through this module has followed the path of a Formula 1 racing team.

  • The Gap Analysis (Sec 17.1) was designing your race car to meet every single technical specification in the 1,000-page F1 rulebook.
  • The QMS (Sec 17.2-17.3) was the engine, the data systems, and the “blameless” pit crew culture you built.
  • The Internal Audit (Sec 17.4) was your team running its own “mock race” in the simulator to find flaws.
  • The Initial Accreditation Survey was the final inspection. The officials came, approved your car, and handed you your “License to Race.”

So, what happens now? The racing season begins. This is the three-year “maintenance phase.” Your license isn’t a trophy for the wall; it’s the entry ticket to the season. And now, you must prove your performance at every single race.

  • Pillar 1: Ongoing Data Submission: This is your live race telemetry. After every race (every quarter), you *must* submit your performance data (adherence rates, turnaround times) to the race officials (URAC/Payers). If your data is bad, they can fine you or pull you from the network.
  • Pillar 2: P&P / Document Lifecycle: The F1 rulebook (the “standards”) changes every single year to improve safety. Your team *must* get the new rulebook, perform a “Gap Analysis” on your car, and re-engineer the components to remain compliant. This is your “Annual P&P Review.”
  • Pillar 3: Re-Accreditation: This is the end-of-season “Championship Review” to renew your license for *next* year. The officials don’t just look at your car. They review your *entire season’s performance*. They look at your telemetry (your data submissions), your incident reports (your RCAs/CAPAs), and your maintenance logs (your internal audits). They are checking that you weren’t just compliant on day one, but that you were a professional, high-performing team for all 3 years.

Your job as the CASP is to be the Team Principal, ensuring the data is clean, the car is compliant, and the team is always ready for race day.

17.5.2 The Three Pillars of Accreditation Maintenance

A successful maintenance program is not a single activity but a continuous, multi-pronged effort. We can break this “forever process” down into three core pillars of activity. Your QMS, and specifically your Quality Management Committee (QMC), will be responsible for overseeing all three pillars simultaneously.

Pillar 1: Data Management & Submission

(The “Proof of Performance”)

This is the quantitative proof that your pharmacy is effective. It involves the continuous collection, analysis, and submission of mandatory performance metrics (e.g., adherence, TAT, satisfaction) to both accreditation bodies and payers. This is the “telemetry” from our analogy.

Pillar 2: Document & P&P Lifecycle

(The “Living Blueprint”)

This is the qualitative proof that your pharmacy is compliant. It involves the continuous review, revision, and version control of all P&Ps, forms, and logs, triggered by internal (CAPA/PDSA) or external (new standards) events. This is the “rulebook” from our analogy.

Pillar 3: Continuous Readiness & Renewal

(The “Culture of Compliance”)

This is the proactive proof that your pharmacy is vigilant. It involves the execution of your Internal Audit schedule (Sec 17.4), ongoing staff training, and the formal project management of the re-accreditation (renewal) application cycle.

The rest of this section will be a deep dive into the practical, “how-to” management of each of these three pillars.

17.5.3 Pillar 1: Masterclass on Ongoing Data Submission

This is, for many payers and for URAC, the single most important part of maintenance. Your accreditation is not just based on your ability to perform, but on your actual performance. This is where your QMS (Sec 17.3) and your data aggregation skills become critical.

What Data Must You Collect and Submit?

The data you collect falls into three categories. You must have a system to capture and report on all three.

Masterclass Table: The Three Buckets of Performance Data
Data Bucket What It Is Key Examples Primary Consumer
1. Accreditation-Mandated Measures A set of standardized, required performance metrics defined by the accreditation body. You *must* collect, trend, and submit these to maintain your status.
  • URAC: Adherence (PDC), Dispensing Turnaround Time (TAT), Call Center Performance (Abandon Rate), Patient Satisfaction (using a validated tool).
  • ACHC: Patient Satisfaction, Patient Complaints, Adverse Events.
 The Accreditation Body (e.g., URAC, ACHC). Submitted annually or quarterly via their online portal.
2. Payer-Contracted Measures Metrics defined in your individual contracts with PBMs and Health Plans. These are often tied to financial penalties or performance bonuses.
  • PDC Adherence > 90% for specific drugs (e.g., Humira, Enbrel).
  • New Rx TAT < 48 hours.
  • Call Center Avg. Speed to Answer < 30 seconds.
  • (This is your “PBM Scorecard”).
 The Payer/PBM. Submitted quarterly or monthly. This is a high-stakes business function.
3. Internal QMS Measures Metrics that *you* choose to track (based on Sec 17.3) to monitor the health of your *own* systems. These are for your QMC only.
  • Near-Miss Rate (Are people reporting?).
  • Transcription Error Rate (Is your #1 gap improving?).
  • Cold Chain Breach % (Is your new P&P working?).
  • Internal Audit Compliance % (Are we following our own rules?).
 Your QMC (Quality Management Committee). Reviewed quarterly to find new problems and assign PDSAs.

The Data Lifecycle: A “How-To” Guide

Having this data is not enough. You must have a process for managing it. As the CASP and QMC leader, this is your responsibility.

Playbook: The Quarterly Data Management Cycle

This cycle should be a formal, standing agenda item for your quarterly QMC meeting.

Phase 1: Collection (Month 3, Week 4)

  • Your Data Analyst (or you) runs the reports for the previous quarter.
  • Source 1 (EMR): Run report for Adherence (PDC) by drug. Run report for TAT (New vs. Refill).
  • Source 2 (Phone System): Run report for Call Center (Abandon %, Avg. Speed to Answer).
  • Source 3 (Incident System): Run the aggregation reports (Pareto/Heat Map) for all errors and near misses.
  • Source 4 (Survey Vendor): Receive the quarterly Patient Satisfaction report.

Phase 2: Analysis & Dashboard (Quarterly QMC Meeting)

  • All this data is compiled into a single “Quarterly Quality Dashboard” (a 1-2 page summary).
  • The QMC reviews the dashboard, line by line. You are looking for trends and thresholds.
  • Question 1 (Thresholds): “Did we meet our external targets?”
    • Example Finding: “Payer X requires 90% PDC. Our RA-drug PDC was 88%. This is a High-Risk Finding.”
  • Question 2 (Trends): “Is any *internal* metric getting worse?”
    • Example Finding: “Our ‘Transcription Error’ rate, which we fixed with a PDSA 6 months ago, is climbing back up. This indicates Policy Drift.”

Phase 3: Action (The QMC’s Job)

  • The QMC *must* act on these findings. The “minutes” of this meeting are your proof.
  • Action 1 (for Threshold Failure): “The 88% PDC rate triggers a formal RCA. A sub-team (led by the CASP) will investigate the root cause of the RA adherence drop and present a CAPA at the next meeting.”
  • Action 2 (for Trend Failure): “The ‘Policy Drift’ on transcription errors triggers a new Internal Audit (Sec 17.4) and a ‘back-to-basics’ staff re-training. This will be led by the Operations Lead.”

Phase 4: Submission (The Administrative Step)

  • After the QMC has reviewed and blessed the data, the Quality Manager logs into the URAC/ACHC portals and uploads the required quarterly/annual measures.
  • The same data is formatted and sent to the PBMs as required by your contracts.
The Surveyor’s Trap: Data Without Action

This is a critical failure point. At your renewal survey, you proudly show the surveyor your beautiful “Quality Dashboard” with 12 months of data.

The surveyor points to Q2, where your “Cold Chain Breach” metric spiked to 15%. They ask, “This is a clear trend. Show me the QMC meeting minutes from Q3 where you discussed this. Show me the RCA you performed. Show me the CAPA you implemented. And show me the data from Q4 that proves your CAPA worked and the trend went back down.”

If your answer is, “Oh, we just noted it and kept watching it,” you have FAILED. You have proven that your QMS is a “data-only” system. You have a “dashboard” but no “engine.”

The Rule: Data collection is meaningless. It is the analysis and action (RCA/CAPA/PDSA) that follows the data that constitutes a compliant QMS.

17.5.4 Pillar 2: The “Living” P&P Manual (Lifecycle Management)

In the 3 years between your accreditation surveys, your pharmacy will not stand still. You will launch new drugs, use new software, and hire new people. The accreditation standards themselves will be updated (e.g., from URAC v4.0 to v5.0). If your P&P manual—your “blueprint”—is not updated to reflect these changes, it becomes a work of fiction. A “dead document.”

Your maintenance program must treat your P&P manual as a “living” library that is under constant, formal review and revision. This is called “Document Lifecycle Management.”

The 5 Triggers for a P&P Revision

A P&P should only be revised for one of these five specific reasons. Every revision must be approved by the QMC.

  1. 1. Accreditation Standard Update (External Trigger): URAC or ACHC releases a new version of their standards. This *must* trigger a “P&P Audit” (from Sec 17.4) of your entire manual against the new standards. This will generate multiple “gaps” that must be fixed by revising your P&Ps.
  2. 2. Preventive Action (Internal Trigger): Your RCA/CAPA process (Sec 17.2) for a medication error identifies a “Preventive Action” of “Revise P&P #7.3 to include a rural zip code check.” This is a mandatory, high-priority revision.
  3. 3. Process Improvement (Internal Trigger): Your PDSA cycle (Sec 17.2) for improving intake time identifies a new, better workflow. When you “Adopt” this new process, you *must* codify it by revising the Intake P&P.
  4. 4. Change in Business Operations (Internal Trigger): You buy a new EMR. You launch a new Home Infusion service. You sign a contract with a PBM that has a new requirement. All of these require *new* or *revised* P&Ps to match the new reality.
  5. 5. The Mandatory Annual Review (Calendar Trigger): This is the “backstop.” Accreditation *requires* that every single P&P is reviewed and re-approved by leadership (e.g., PIC and QMC) on a defined schedule (at least annually or biennially). This is to catch any “policy drift” and ensure P&Ps are not forgotten.

The “Paper vs. Practice” Nightmare: Policy Drift

This is the most common P&P-related failure. Policy Drift is the natural tendency for your team’s actual practice to slowly, organically drift away from the written P&P over time. This happens for innocent reasons: staff find “clever workarounds” to save time, a new manager verbally changes a process, or new software makes an old P&P obsolete.

Example:

  • The P&P (Paper): “The pharmacist must document a 10-point clinical review in the ‘Clinical Note’ free-text field.” (Written 3 years ago).
  • The New Software (Change): The new EMR, installed 2 years ago, has a “Clinical Review” *tab* with *check boxes*.
  • The “Drift” (Practice): The pharmacists stopped using the free-text field (it’s slow) and now use the new check-box tab. They are still doing the work, but…
  • The GAP: Your practice no longer matches your P&P.
  • The Survey Failure: The surveyor reads your P&P and asks to see the “Clinical Note” free-text field. It’s empty. You have zero proof of compliance, even though you were doing the work. You failed.

Your Annual P&P Review and your Internal Tracer Audits are your only two weapons to fight this. The Tracer would have found this gap in 5 minutes. The Annual Review would have updated the P&P to match the new EMR workflow. This is why maintenance is not optional.

Tutorial: P&P Lifecycle Management & Version Control

You cannot just “edit” a P&P file. That’s a document control nightmare. A surveyor must be able to see the history of the document. You must have a formal, locked-down process for “Version Control.”

Playbook: The 6-Step P&P Revision & Lifecycle

This process is managed by your Quality Manager (or you) and approved by your QMC.

  1. Step 1: The “Change Request”: A “Trigger” occurs (e.g., a CAPA identifies a needed change). A formal “P&P Change Request” is submitted to the QMC.
  2. Step 2: The “Draft” (v2.1_DRAFT): The P&P “Owner” (e.g., the Pharmacist Lead) takes the current “live” P&P (v2.0) and creates a new file. They “redline” the changes. This new file is named “P&P_8.1_v2.1_DRAFT.”
  3. Step 3: The “Approval”: The DRAFT is presented to the QMC. The committee reviews and approves the changes. This approval is documented in the QMC’s official Meeting Minutes. (This is your *proof of review*).
  4. Step 4: The “Training” (CRITICAL): The new P&P (v2.1) is used to re-train all affected staff. You *must* have a “Training Log” or “Competency Assessment” with staff signatures to prove they were trained on the new process *before* it went live.
  5. Step 5: The “Go-Live”: On the “Effective Date,” the Quality Manager performs two actions:
    • The *old* P&P (v2.0) is moved from the “Active P&P” folder to the “Archive P&P” folder. (You *never* delete old P&Ps. Surveyors may ask to see them).
    • The *new* P&P (v2.1) is placed in the “Active P&P” folder, becoming the new, official policy.
  6. Step 6: The “Master Index Update”: The Quality Manager opens the “Master P&P Index” spreadsheet and updates the line for P&P 8.1.
Masterclass Template: The “Master P&P Index”

This is the most powerful tool for managing your documents and proving compliance to a surveyor. It is a simple spreadsheet that lists every controlled document in your pharmacy.

P&P ID P&P Title P&P Owner Current Version Effective Date Mandatory Review (1-Yr) Last Review Date Next Review Date Status
P&P 2.1 Patient Intake Ops Lead v3.0 06/01/2025 Annual 06/01/2025 06/01/2026 Compliant
P&P 3.5 Prior Authorization PA Lead v2.2 01/15/2025 Annual 01/15/2025 01/15/2026 Compliant
P&P 4.1 Clinical Review RPh Lead (You) v2.0 10/30/2023 Annual 10/30/2023 10/30/2024 OVERDUE
P&P 7.3 Cold Chain Shipping Ops Lead v1.0 03/01/2022 Annual 03/01/2024 03/01/2025 Up for Review

This simple tool, when sorted by “Next Review Date,” instantly becomes your QMC’s “To-Do” list for P&P maintenance. The “OVERDUE” status for P&P 4.1 is a high-risk gap that must be fixed immediately.

17.5.5 Pillar 3: Preparing for Re-Accreditation (The Renewal Cycle)

You have successfully maintained your QMS for 3 years. You’ve submitted your data (Pillar 1) and kept your P&Ps alive (Pillar 2). Now, it’s time to “re-up” your license. The re-accreditation (or “renewal”) process is a formal project that you must begin 9-12 months before your current accreditation expires.

This is not a “mock survey.” It is a formal project to find your gaps and “true up” your entire QMS before the surveyor arrives. The renewal survey is tougher than the initial one. The surveyor’s expectations are higher. They expect you to be fluent in your own QMS.

The Re-Accreditation Timeline: A 12-Month “Countdown-to-Survey”

Playbook: The 12-Month Renewal Project Plan
Phase 1: The “New Standard” Gap Analysis (12 Months Out)
  • Action: Go to the URAC/ACHC website and purchase the newest version of the standards (e.g., you were accredited on v4.0; they are now surveying on v5.0).
  • Action: Your QMC performs a “P&P Audit” (from Sec 17.4) comparing your current P&Ps against the new standards.
  • Goal: To identify “New Gaps” created by the new standards (e.g., “The new v5.0 standards have a whole new section on ‘Health Equity.’ We have no P&Ps for this.”).
  • Outcome: A list of new CAPAs and PDSAs to get your “paper” compliant with the new rules. This is your #1 priority.
Phase 2: The “Look-Back” Audit (9 Months Out)
  • Action: Your internal audit team “plays surveyor” and audits your history. This is the new, critical step for renewals.
  • The “Look-Back” Checklist (Your Audit Tool):
    • “Pull all 12 QMC meeting minutes from last year.” (Are any missing? Do they show data analysis?)
    • “Pull all Internal Audit Tracers from the last 24 months.” (Did we follow our own audit schedule?)
    • “Pull the Annual P&P Review log.” (Did we really review every P&P, every year? Is P&P 4.1 still overdue?)
    • “Pull 5 CAPAs from 2 years ago.” (Did we ever *validate* that the fix worked?)
    • “Pull staff training files for all P&Ps revised last year.” (Is the documentation complete?)
  • Goal: To find your documentation and follow-through gaps.
  • Outcome: A (likely terrifying) list of documentation you are missing. This gives you 9 months to find it or fix it.
Phase 3: The Full-Scale “Mock Survey” (6 Months Out)
  • Action: You execute your “Annual Mock Survey” (from Sec 17.4). This is your “dress rehearsal.”
  • Methodology: 10-20 patient tracers. Staff interviews. Facility inspection.
  • Goal: To find your current “Paper vs. Practice” Gaps. (e.g., “Our new ‘Health Equity’ P&P is beautiful, but our tracers show that none of the intake techs are asking the new required questions.”).
  • Outcome: A final, high-priority list of CAPAs focused on staff re-training and process fixes.
Phase 4: The Application & Submission (4-6 Months Out)
  • Action: You pay the re-accreditation fee and formally submit your application.
  • Action (for URAC): This is when your “Desktop Review” begins. You must upload all your *newly revised* P&Ps (that you fixed in Phase 1) and all your *performance data* (from Pillar 1) for their review.
  • Goal: To pass the “paper” portion of the audit.
Phase 5: The “Final Push” & Survey (1-3 Months Out)
  • Action: You are fixing all the gaps from your “Mock Survey.” You are re-training staff, cleaning the facility, and ensuring all logs are perfect.
  • Action: The surveyor schedules their on-site visit.
  • The Survey Itself: You host the surveyor. You use your “Look-Back” audit, your “QMC Dashboard,” and your “Mock Survey” findings as your evidence. You don’t hide your flaws; you showcase them as proof of your functioning QMS. (e.g., “We found in Q2 that our adherence dropped. Here is the RCA we performed and the CAPA we implemented. You can see in Q3 our adherence recovered.”).

17.5.6 Your Role as the CASP: The “QMS Steward”

This entire module—from Gap Analysis to Renewal—transforms your role. You are not just a clinical expert; you are a Quality Management System Steward. This is one of the highest-level functions of an advanced, certified pharmacist, blending clinical expertise with administrative, regulatory, and leadership excellence.

Your role in the maintenance phase is the most critical on the team. You are the “Team Principal” from our analogy. Your specific, ongoing responsibilities are:

  • 1. The Data Analyst: You are the lead clinical voice on the QMC. You are the one who looks at the “Data Dashboard” (Pillar 1) and provides the clinical interpretation of the numbers (e.g., “Our RA adherence dropped 5%, and I think it’s because of the new ‘black box’ warning. Our PMP needs to be updated to address this fear.”).
  • 2. The Chief Editor: You are the primary clinical “P&P Owner” (Pillar 2). You will be the one writing and revising the most complex P&Ps—the Patient Management Programs, the clinical protocols, the side effect management algorithms.
  • 3. The “Chief Surveyor”: You are the leader of the Internal Audit Program (Pillar 3). You have the clinical expertise to design and execute the most complex Patient Tracers (Sec 17.4), as you are the only one who can truly spot the clinical “Paper vs. Practice” gaps.
  • 4. The Project Manager: You are the de facto Project Manager for the Re-Accreditation Project. You will own the 12-month timeline, you will lead the “Look-Back” audit, and you will be the “peer” who speaks to the pharmacist-surveyor when they arrive.
  • 5. The Cultural Champion: Most importantly, you are the champion who fights against “audit fatigue” and “policy drift.” You are the leader who continuously sells the “why” to the staff, celebrating the “near-miss” reports and showcasing the “You Reported, We Fixed” wins. You are the one who ensures the QMS you built remains a living, breathing part of the pharmacy’s culture, long after the first plaque is on the wall.