CASP Module 2, Section 2: Accreditation Standards (URAC, ACHC, TJC, NABP)
Module 2: Regulatory, Accreditation & Quality Frameworks

Section 2.2: Accreditation Standards (URAC, ACHC, TJC, NABP)

A deep dive into the major accreditation bodies, comparing their standards for patient management, quality, operations, and demonstrating compliance.

SECTION 2.2

Accreditation Standards

From “Nice to Have” to a Non-Negotiable “Ticket to Play.”

2.2.1 The “Why”: Accreditation as the Language of Trust and Access

In your community practice, the ultimate mark of quality was your pharmacist license on the wall and the trust of your local patients and prescribers. You were regulated by your State Board of Pharmacy, and that was the beginning and the end of your required credentials. In the world of specialty pharmacy, that is just the starting line.

Accreditation is the universal language of quality and trust in the specialty ecosystem. It is a formal, third-party validation that your pharmacy doesn’t just *claim* to provide high-touch, complex clinical services, but that it has been rigorously audited and proven to do so according to a nationally recognized set of standards.

Why is this non-negotiable? Because of the key stakeholders who demand it:

  • Payers (PBMs & Health Plans): Payers will not grant you access to their specialty pharmacy network—and thus, access to their patients—without accreditation. For them, it’s a risk-management tool. It proves you have the clinical programs (like adherence and side effect management) to protect their $100,000-per-year investment in a patient’s drug therapy. They mandate it.
  • Manufacturers (Pharma): Manufacturers will not grant you access to their Limited Distribution Drug (LDD) list without accreditation. For them, it’s a brand-protection tool. It proves you have the operational integrity (especially for cold chain) and the clinical data-reporting capabilities they require. They mandate it.
  • Prescribers (Health Systems): Large health systems and physician groups will not route their complex patients to you without accreditation. For them, it’s a continuity-of-care tool. It proves you are a reliable partner who can manage their patient’s complex journey and prevent readmissions.

Therefore, accreditation is not a “nice-to-have” certificate to hang on the wall. It is the fundamental key that unlocks the door to payer networks and drug access. Without it, a specialty pharmacy cannot exist. Your role as an advanced specialty pharmacist is not just to be *aware* of these standards, but to be an active participant in *upholding* them. You are the one who performs the patient assessments, you are the one who follows the quality protocols, and you are the one who will be interviewed by the surveyors. This section is your guide to understanding the “what” and “why” behind the standards you will live by every day.

Pharmacist Analogy: Accreditation as University Degrees

Think of pharmacy accreditation like university degrees. In your community practice, your Pharmacist License is your High School Diploma—it’s the essential, mandatory credential from the state (your State BOP) that says you are safe to practice.

Specialty accreditation is the next level:

  • Why do you need a “college degree”? Because the “employers” (Payers and Pharma) require it for the high-paying, complex “jobs” (network access and LDD contracts). Your diploma isn’t enough.
  • Which “university” do you attend? This is the choice between URAC, ACHC, TJC, and NABP.
    • URAC is like the Ivy League (e.g., Harvard, Yale). It’s the oldest, most established in the payer world, and known for its intense, research-heavy, data-driven focus. Graduating (getting accredited) is tough, respected, and instantly recognized by all the top “employers” (PBMs).
    • ACHC is like a Top-Tier, Pharmacist-Founded University (e.g., a “Best in the Nation” PharmD Program). It’s known for its practical, educational, and collaborative approach. It has a stellar reputation, and many “employers” now see it as equivalent or even preferable to the Ivy League due to its real-world focus.
    • TJC (The Joint Commission) is the Medical School attached to a University Hospital. If you’re already in the “hospital system” (i.e., your health-system is already TJC-accredited), getting your “Specialty Certification” from them is the most logical step. It’s all about integrating with the hospital’s patient safety and quality ecosystem.
    • NABP is the State University System’s Flagship School. It’s run by the same people who gave you your diploma (the association of State BOPs). Its “degree” is deeply respected, with a strong focus on operational integrity, licensure, and supply chain security—all the things the state boards care about most.

Just like in academia, there is debate about which “degree” is “best.” The truth is, they are all highly respected and will get you the “job.” The choice often depends on your pharmacy’s “personality” and business goals. Your job as a pharmacist is to be the “A-student” who knows the “curriculum” of whichever school you attend.

2.2.2 The “Big Four”: A High-Level Comparison

While all four bodies aim to validate quality, they have distinct “personalities” and areas of focus. The choice of which accreditation to pursue is a major strategic decision for an SP.

Masterclass Table: The “Big Four” Accreditation Bodies Compared
  • Quality Management: Mandates specific PQA/URAC performance measures (e.g., adherence, turnaround time).
  • Clinical Model: Highly detailed standards for patient management, care plans, and case management.
  • Risk Management: Strong focus on operational and clinical risk.
  • Patient Journey: Standards are structured to follow the patient’s path, from intake to outcomes.
  • Educational Approach: Surveyors often focus on teaching and continuous improvement, not just “gotcha” findings.
  • Clinical Oversight: Strong emphasis on the pharmacist’s clinical role and patient-provider coordination.
  • Continuity of Care: Heavy focus on safe transitions of care (e.g., inpatient to outpatient specialty).
  • Patient Safety Goals: Aligns SP standards with TJC’s well-known National Patient Safety Goals (NPSGs).
  • Infection Control: Strong standards for handling and compounding.
    • The “Regulator’s Choice.” Operationally focused, emphasizing compliance and supply chain integrity.
  • Licensure & Compliance: The most rigorous standards for verifying all state non-resident licenses for the pharmacy and staff.
  • Operations: Deep focus on dispensing accuracy, P&P management, and operational workflows.
  • Supply Chain: Integrates with its other programs (e.g., DSCSA compliance, VPP) for unmatched supply chain security.
    • Accreditation Body “Personality” / Core Philosophy Primary Focus / Strengths Typical “Customer”
    URAC
    (Specialty Pharmacy Accreditation)    		 The “Payer’s Choice.” Data-driven, prescriptive, and metric-heavy. The “gold standard” for PBMs.
    ACHC
    (Accreditation Commission for Health Care)    		 The “Pharmacist’s Choice.” Educational, collaborative, and patient-centric.
    TJC (The Joint Commission)
    (Specialty Pharmacy Certification)    		 The “Hospital’s Choice.” Patient safety-focused, integrating the SP into the wider health-system.
    NABP
    (National Association of Boards of Pharmacy)

    2.2.3 Masterclass Deep Dive: Core Domains Compared

    This is the heart of accreditation. While the names of the standards differ, all bodies audit the same fundamental components of your specialty pharmacy practice. As a specialty pharmacist, your daily work is a living demonstration of these standards. We will now deconstruct these core domains and provide practical, actionable guides for how you, the pharmacist, will meet them.

    Domain 1: Patient Management & Clinical Model

    This is the most significant domain and the one most central to your clinical role. It governs the entire patient journey, from the moment the referral arrives to the long-term management of their therapy. Both URAC and ACHC are intensely focused here.

    A. Patient Intake, Benefit Investigation (BV), and Financial Assistance

    The Standard: The SP must have a defined process to accept new patients, triage their needs, verify their complex benefits, and exhaust all financial assistance options before even considering collecting a high patient cost-share.

    Your Role as a Pharmacist: While a technician or reimbursement specialist may perform the BV, you are the clinical anchor. You are responsible for assessing the clinical urgency of the referral. A prescription for a new-start oncology drug or an organ transplant medication cannot wait 3-5 days for a standard benefit check. You must triage the prescription and flag it for immediate, STAT processing. You are also the final clinical check, ensuring the financial assistance found is appropriate (e.g., applying for a co-pay card is fine; enrolling a Medicare patient in a manufacturer-sponsored co-pay program is a violation of the AKS, as we learned in 2.1).

    Playbook: The “Triage” Standard in Practice

    A surveyor will test this by asking, “Show me your process for handling a clinically urgent referral.”

    Your Answer (Speaking to the Standard):

    1. “When a referral arrives, it is immediately reviewed by a pharmacist or under a pharmacist’s protocol. We have a ‘Clinical Urgency’ policy.”
    2. “We identify STAT medications based on specific criteria: is it a new-start oncology agent? A post-transplant immunosuppressant? A discharge prescription from the hospital?”
    3. “If ‘STAT’ is triggered, the prescription bypasses the standard 72-hour BV queue and is assigned to a dedicated STAT reimbursement specialist for immediate processing, with a goal of same-day or next-day turnaround.”
    4. “I, as the pharmacist, remain in constant communication with the prescriber’s office and the patient, managing their clinical needs (e.g., ‘Do you have a 3-day supply from the hospital?’) while the BV is in progress.”
    B. The Patient Care Plan (PCP) & Pharmacist Assessment

    The Standard: This is the single most important clinical document in your accreditation file. The SP must perform a comprehensive, pharmacist-driven initial assessment of the patient and use that information to develop a written, individualized Patient Care Plan (PCP). This plan must be shared with the patient and the prescriber. It cannot be a generic, one-size-fits-all document.

    Your Role as a Pharmacist: You are the author and owner of this document. This is your “SOAP note” for the patient’s entire course of therapy. Your initial assessment call is a formal, structured interview designed to gather the data needed to build this plan. The plan itself must, at a minimum, identify:

    • The Patient’s Diagnosis and Drug Therapy: The “Subjective” and “Objective.”
    • The Therapeutic Goals: What are you trying to achieve? (e.g., “Reduce psoriasis plaques,” “Achieve viral suppression,” “Prevent organ rejection”).
    • Potential Problems/Barriers: This is your “Assessment.” (e.g., “Patient has high co-pay,” “Patient has needle phobia,” “Patient has a history of non-adherence,” “Drug has high risk of hepatotoxicity”).
    • Interventions & Plan: This is your “Plan.” (e.g., “Enroll patient in co-pay card,” “Schedule injection training with nurse,” “Set up adherence reminder calls,” “Ensure patient has follow-up labs ordered for LFTs in 2 weeks”).
    Masterclass Table: Building a Compliant Patient Care Plan
    Care Plan Domain Pharmacist Assessment Questions (On the Initial Call) Sample Care Plan Entry (The “P” in your SOAP Note)
    Clinical / Therapy Management “What has your doctor told you about this new medication? What side effects are you most concerned about? What other medications, including OTCs and supplements, do you take?” Problem: New therapy, high risk of GI toxicity. Goal: Ensure patient is educated on side effects and labs. Intervention: RPh counseled patient on 1-hour call; provided link to video; will call patient in 3 days for “Day 3 Check-in”; will verify LFTs are drawn in 2 weeks.
    Adherence / Psychosocial Barriers “This drug is a daily injection. How do you feel about giving yourself a shot? What system do you use to remember to take your medications every day? Do you have a caregiver who helps you?” Problem: Patient has needle phobia and lives alone. Goal: 100% adherence. Intervention: RPh scheduled a telehealth injection training session with RN; set patient up for weekly automated adherence reminder calls; will assess adherence at each refill.
    Financial Barriers “The benefit check shows your co-pay will be $250/month. Is this something that is manageable for you, or would you like me to see what assistance is available?” Problem: Patient has $250 co-pay and states they cannot afford it. Goal: Reduce co-pay to <$50. Intervention: RPh transferred patient to Reimbursement Specialist, who enrolled patient in manufacturer co-pay card. Co-pay is now $5.
    C. Clinical Monitoring, Re-Assessment, and Adherence Management

    The Standard: The SP must have a formal program to To-go” call, but a scheduled clinical re-assessment. You must re-evaluate the patient (e.g., “Are you having any new side effects?”), their adherence (e.g., “How many doses have you missed in the last 30 days?”), and their progress toward the goals in the Patient Care Plan. This re-assessment must be documented, and the Care Plan updated.

    Your Role as a Pharmacist: You are the clinician performing this re-assessment. Accreditation standards are *prescriptive* about this. They require you to have a defined adherence management program. This is where your community pharmacy “med sync” and “refill reminder” skills are formalized.

    Playbook: The Adherence Management Program

    A surveyor will ask, “Show me your adherence management program. What do you do if a patient is non-adherent?”

    Your Answer (Speaking to the Standard):

    1. “We measure adherence for all patients using a standard formula, Proportion of Days Covered (PDC). We calculate this at every refill and for our quarterly Quality Management program.”
    2. “Any patient who falls below our 85% PDC threshold is automatically flagged for a pharmacist-led adherence intervention.”
    3. “During this intervention, I perform a root cause analysis to identify the barrier. Is it cost? Side effects? Forgetfulness? A psychosocial issue?”
    4. “Based on the barrier, I implement a targeted intervention from our protocol:
      • Cost: Re-investigate financial aid.
      • Side Effects: Counsel on management (e.g., take with food, anti-nausea meds) and communicate with the prescriber.
      • Forgetfulness: Enroll the patient in our high-touch adherence calls, offer compliance packaging (blister packs), or help them set up a smartphone app reminder.
    5. “This entire intervention is documented as an update to the Patient Care Plan, and I coordinate the plan with the prescriber’s office.”

    Domain 2: Quality Management (QM) & Performance Improvement

    This domain is the “brain” of the accredited pharmacy. It’s the formal system you use to measure your own performance, find your mistakes, and prove that you fixed them. As a pharmacist, you are a key player on the Quality Management Committee (QMC).

    A. The Quality Management Program & Committee

    The Standard: The SP must have a formal, written QM Program that is led by a multidisciplinary QMC. This committee must meet regularly (e.g., quarterly) to review performance data, patient complaints, and safety incidents. It must be empowered by leadership to make real changes.

    Your Role as a Pharmacist: You will be a member of this committee, representing the clinical arm of the pharmacy. You will be responsible for bringing data from your clinical re-assessments (e.g., “I’ve seen 5 patients this month report nausea with drug X”), analyzing dispensing errors, and helping to develop solutions (known as Performance Improvement Projects, or PIPs).

    B. Mandatory Performance Measures (The URAC Difference)

    The Standard: This is a major differentiator. URAC, in particular, mandates that your SP must measure, collect, and report on specific performance measures. Many of these are aligned with the Pharmacy Quality Alliance (PQA). This is not optional.

    Your Role as a Pharmacist: Your daily work directly creates the data for these measures. When you document an adherence intervention or process a prescription, you are feeding the machine. The QMC then analyzes this data. ACHC and NABP also require quality metrics, but URAC’s are the most prescriptive.

    Masterclass Table: Common Accreditation Quality Measures
    Safety
    Measure Category Specific Measure Example How It’s Measured (The “Tutorial”) Pharmacist’s Impact
    Adherence Proportion of Days Covered (PDC) for specific drug classes (e.g., Hepatitis C, MS, RA). (Days’ Supply Dispensed in Period) / (Number of Days in Period). An 85% or 90% threshold is the typical goal. Your adherence interventions are the only way to improve this score. This is your #1 clinical contribution to the QM program.
    Operational Dispensing Turnaround Time (TAT) (Date/Time Dispensed) – (Date/Time of “Clean” Referral). “Clean” means the prescription is clinically appropriate and has benefits verified. Your speed in clinical review (the “RPh Verify” step) is a key component. You must not let prescriptions “sit” in your queue.
    Clinical Persistence of Therapy The percentage of patients who are still on their therapy after 6 months or 1 year. Your side effect management and patient education calls are the primary drivers of persistence. This proves your clinical value.
    Dispensing Accuracy Rate (or Error Rate) (Number of Dispensing Errors) / (Total Prescriptions Dispensed). Errors are found via patient complaints or internal QA. This is your core retail skill. Every prescription you verify contributes to this metric. This is a lagging indicator of quality.
    Patient Experience Patient Satisfaction Score (e.g., “Likelihood to Recommend”) Calculated from mandatory, third-party-administered patient satisfaction surveys. Every phone call you make, every time you solve a co-pay problem, you are directly impacting this score. This is a key measure of service quality.
    C. Performance Improvement Projects (PIPs) & Root Cause Analysis (RCA)

    The Standard: It’s not enough to *find* problems. The SP must have a formal, documented process for *fixing* them. This is the Plan-Do-Check-Act (PDCA) cycle.

    Your Role as a Pharmacist: You will lead or participate in these PIPs. The most common tool you will use is the Root Cause Analysis (RCA). This is a formal investigation method that pushes you past the “human error” answer.

    Tutorial: A Simple Root Cause Analysis (RCA)

    The Event: A patient received their refrigerated Humira in a non-refrigerated “room temperature” box. The patient called to complain.

    The “Bad” (Surface-Level) Analysis: “The shipping tech, Bob, made a mistake. He used the wrong box. We will retrain Bob.”

    The “Good” (RCA) Analysis (using the “5 Whys”):

    1. Why did this happen? Bob used the wrong box.
    2. Why did Bob use the wrong box? He grabbed the “Room Temp” pack-out materials instead of the “Cold Chain” pack-out materials.
    3. Why did he grab the wrong ones? Both sets of materials are stored in identical blue bins, right next to each other in the shipping station.
    4. Why are they stored this way? The shipping station is small and was never designed to hold two different pack-out types.
    5. Why haven’t we fixed this? We haven’t had a major error until now.

    The Root Cause: A poor, error-prone workflow and station design (a system failure), not just “human error.”

    The Solution (The “Act” in PDCA):

    • Short-Term: Move the Cold Chain materials to a completely separate, red-colored cart on the other side of the room. Label all cold chain bins with large, red “REFRIGERATED” stickers.
    • Long-Term: Redesign the shipping station to physically separate the two workflows.
    • Global: Retrain *all* shipping techs on the new workflow.

    This documented RCA and the subsequent PIP are exactly what a surveyor will want to see.

    Domain 3: Pharmacy Operations & Dispensing

    This domain covers the physical handling of the drug. As a pharmacist, you are the final owner of this entire process, from inventory management to the patient’s doorstep. NABP and TJC are particularly strong here.

    A. Cold Chain Management & Shipping Validation

    The Standard: This is one of the highest-risk areas in specialty. The SP must have a robust, validated process to ensure refrigerated (2-8°C) medications stay within that temperature range from the moment they leave the pharmacy to the moment the patient opens the box. You cannot just “guess” and throw a few gel packs in a cooler.

    Your Role as a Pharmacist: You are responsible for ensuring this program is scientifically sound. This involves two key components:

    1. Ongoing Monitoring: Daily temperature monitoring and logging of all refrigerators and freezers, with excursion reports for any out-of-range temps. This is a basic BOP requirement, but accreditation requires you to show your logs for the past 1-3 years.
    2. Pack-Out Validation: This is the most complex part. You must have objective evidence that your chosen shipping cooler, gel packs, and packing method (your “pack-out”) can maintain 2-8°C for the *entire duration* of the shipment (e.g., 48 hours), in both the *hottest* and *coldest* months of the year.
    Tutorial: How to Perform a Pack-Out Validation Study

    A surveyor will ask, “Show me your cold chain pack-out validation study.” You can’t just point to the cooler manufacturer’s website. You must have your *own* study.

    The Process (Simplified):

    1. Define Variables: You need a “Summer Pack-Out” (e.g., 8 gel packs) and a “Winter Pack-Out” (e.g., 4 gel packs, plus insulation to prevent *freezing*).
    2. Get a Test Chamber: You will use a certified environmental test chamber that can hold a specific temperature (e.g., 104°F for summer, 0°F for winter).
    3. Run the Study:
      • Prepare your “Summer Pack-Out” (the cooler, 8 gel packs, etc.).
      • Inside the box, place a calibrated digital data logger (DDL) that records the internal temperature every 5 minutes.
      • Place the entire sealed cooler into the test chamber, which is set to 104°F.
      • Let it run for 48 hours (or your maximum shipping time).
      • Repeat this process 3 times (the “3x” validation rule).
    4. Analyze the Data: Download the DDL data. Create a graph. Did the *internal* temperature of the box stay between 2-8°C for all 48 hours, even while the *external* temp was 104°F?
    5. Final Report: The final, signed report with these graphs is your Objective Quality Evidence (OQE). This is your validation. You repeat this entire process for your “Winter Pack-Out.”

    This formal study is what allows you to confidently (and legally) tell a payer you can safely ship their $20,000 drug.

    B. Dispensing, Labeling, and Verification

    The Standard: The SP must have a documented workflow for dispensing, with multiple “hard stops” for quality checks. This goes beyond the standard retail workflow due to the complexity and cost of the drugs.

    Your Role as a Pharmacist: You are the final check. Accreditation standards require this final check to be robust. They will watch your workflow.

    • The “5-Point Check”: Your final RPh verification cannot just be “RTS” (Ready to Scan). You must verify: 1) Correct Patient, 2) Correct Drug, 3) Correct Dose/Directions, 4) Correct Prescriber, and 5) Correct Ancillary Supplies.
    • Ancillary Supplies: A surveyor will check this! If you dispense an auto-injector, does the box include alcohol swabs and a sharps container? If you dispense an oral oncology drug that shouldn’t be handled, did you include gloves? This is a common “gotcha.”
    • Labeling: Specialty drug labels are complex. They must meet all state BOP requirements *plus* any extra requirements from the payer or manufacturer (e.g., “REMS Drug – Do Not Dispense w/o Auth”).
    C. Emergency Preparedness & Disaster Recovery

    The Standard: What happens if a hurricane hits your pharmacy? What if your power is out for 3 days? The SP must have a detailed, written Disaster Recovery Plan that has been tested.

    Your Role as a Pharmacist: You must know this plan. A surveyor will ask you, “Your power just went out. Your backup generator failed. What do you do?”

    Your Answer (Speaking to the Standard): “I immediately activate our Disaster Plan.

    1. Protect Product: We have a protocol to move all refrigerated and frozen drugs from the non-functioning units to our validated, unpowered ‘Disaster Coolers,’ which we know from validation studies will hold temp for 72 hours.
    2. Protect Patients: We transfer our phone lines and data system to our ‘hot site’ backup pharmacy in another state (or our cloud-based system), which can see our queue.
    3. Triage Patients: We run a report of all patients due to ship in the next 72 hours and triage them. We transfer the most critical prescriptions (e.g., transplant, oncology) to a partner specialty pharmacy for fulfillment to ensure no lapse in therapy. We notify all patients and prescribers of the interruption.”

    Domain 4: Organizational Management & Compliance

    This domain covers the “people and paper” of the pharmacy—the human resources and compliance infrastructure that holds everything together. This is where the legal requirements from Section 2.1 are put into practice.

    A. Staff Training, Competency, and Licensure Verification

    The Standard: This is one of the most file-heavy, document-intensive parts of accreditation. The SP must prove that every single employee (pharmacist, tech, call center rep, driver) is thoroughly trained, tested, and regularly evaluated for competency in their specific job. NABP is especially rigorous here.

    Your Role as a Pharmacist: You are both a subject of this standard and a leader of it. You must maintain your *own* competency file, and you will be responsible for training and assessing your technicians.

    Tutorial: Anatomy of a Pharmacist’s Competency File

    A surveyor will pick an employee at random (it could be you) and say, “Pull me the competency and training file for Pharmacist Jane Doe.” That file must be perfectly organized and contain, at a minimum:

    • Pre-Hire Documents:
      • Job Description (signed and dated).
      • Evidence of pre-hire screening (background check, drug screen).
    • Licensure:
      • A copy of their active pharmacist license.
      • Primary Source Verification (PSV): A printout from the State BOP website *proving* you checked that the license is real and active (a copy is not enough). This must be done on hire and *at every renewal*.
    • Initial Training (within 30-90 days of hire):
      • Training Checklists (signed) for: HIPAA, FWA, HR Policies, Disaster Plan, Safety/OSHA.
      • Dispensing Software training log.
      • Disease-State training records for the diseases you manage.
    • Ongoing Competency (Annual):
      • Your annual performance review.
      • Your annual HIPAA and FWA re-training “post-tests.”
      • Annual Competency Assessment: A manager must literally watch you perform a task (e.g., “Counsel a patient”) and fill out a checklist (“Spoke clearly? Used open-ended questions? Verified understanding?”). This must be documented.
      • Annual CEs.
    B. Patient Complaints, Grievances, and Appeals

    The Standard: The SP must have a formal, written process for handling patient complaints. You must log every complaint, investigate it, resolve it within a defined timeframe (e.g., 5-10 business days), and trend the data for your quarterly QM meetings. You must also inform patients of their right to complain.

    Your Role as a Pharmacist: You are often the person who *receives* the complaint. Your job is to de-escalate, empathize, and—most importantly—trigger the formal process. You cannot just say “Oh, I’m sorry” and hang up. You must log it in the system. “Patient called, upset that driver left $10k drug on doorstep without a signature.” This log is what the QMC will review to find trends (e.g., “This is the 5th complaint about that driver this month… we have a performance issue”).

    C. Patient Rights and Responsibilities

    The Standard: You must provide every patient with a written “Patient Rights & Responsibilities” packet at the start of care. This is a legal document that informs them of their rights (e.g., “The right to be treated with respect,” “The right to refuse treatment,” “The right to know who is treating them”) and their responsibilities (e.g., “The responsibility to provide accurate information,” “The responsibility to pay for their care”).

    Your Role as a Pharmacist: You must be able to *explain* these rights. A surveyor may ask you, “What are your patient’s rights?” You should be able to summarize them and, most importantly, know where to find the packet to give to the patient.

    2.2.4 The Accreditation “Get Ready” Playbook: A Practical Tutorial

    As a CASP, you will be a leader in the accreditation process. Here is a practical, step-by-step guide on how a pharmacy achieves its first accreditation.

    Step 1: Choose Your “University” (URAC vs. ACHC)

    This is the first major decision. TJC is usually for health systems and NABP is a common choice for its operational strengths, but the most common decision for a new SP is between URAC and ACHC.

    • Choose URAC if: Your primary business goal is to get into the largest PBM networks (CVS Caremark, ESI, Optum) as fast as possible. They have the longest-standing relationships. Be prepared for a very prescriptive, data-heavy, and expensive process.
    • Choose ACHC if: You want a more collaborative, educational process. ACHC is universally accepted by PBMs and manufacturers and is often preferred by pharmacist-owners. The standards are equally rigorous but written in a more patient-centric “journey” format.

    Step 2: The Gap Analysis & The “P&P Factory”

    Once you buy the standards, you enter the “build” phase. This takes 6-12 months.

    • Gap Analysis: You create a massive spreadsheet. Column A is the Standard (e.g., “SP 2.1 – Patient Assessment”). Column B is “Our Current Process.” Column C is “The Gap.” Column D is “Action Plan.”
    • The P&P Factory: The “Action Plan” almost always involves writing a Policy & Procedure (P&P). Accreditation is run on P&Ps. You will need a P&P for *everything*: a P&P for patient intake, a P&P for cold chain, a P&P for handling complaints. A mature SP will have over 100 P&Ps.
    • Your Role: You will write the clinical P&Ps (Patient Assessment, Counseling, Adherence Management, etc.).

    Step 3: The “Look-Back” Period & Mock Survey

    You cannot just *write* the P&P. You must *prove* you have been *following* it. Most accreditors have a 3-6 month “look-back” period. This means that when you submit your application, you are attesting that you have been “living” these standards for the last 3-6 months.

    The Mock Survey: About 1-2 months before the real survey, you hire a consultant to perform a “mock survey.” They come in for 2 days and act like a real surveyor, tearing your processes apart, finding all your “gaps.” This is a stressful but invaluable dress rehearsal.

    Step 4: The Survey (Virtual or On-Site) – “Showtime”

    This is the 2-3 day main event. A surveyor (almost always an experienced pharmacist) will arrive. Their methodology is called the “Tracer Methodology.”

    The Tracer Methodology: A Tutorial

    The surveyor will not just read your P&P manual. That’s the “says who?” part. They want to see the “show me” part.

    The Process:

    1. The “Tracer”: The surveyor will say, “Give me a list of your new patients from last Tuesday.” They will pick one: “Patient John Smith, new start Humira.”
    2. The File Review: They will “trace” this patient’s entire journey. “Show me the referral. Show me the benefit verification file. Show me the pharmacist’s Initial Assessment. Show me the Patient Care Plan. Show me the counseling note. Show me the dispensing record. Show me the shipping log. Show me the temperature monitoring data for that shipment.”
    3. The Staff Interview: As they review the file, they will find who touched it. “I see Pharmacist Jane Doe did the assessment. I’d like to speak with her.”
    4. The Interview: They will ask you, “Tell me about this patient. What was your plan for them?” Then, “Show me your policy for Patient Assessments.” They are checking to see if what you *did* (in the file) matches what you *say* you do (your P&P).
    5. The “Gotcha”: If your file says “Patient counseled on side effects” but your P&P says “All counseling must use the ‘teach-back’ method and be documented,” the surveyor will ask, “Where in this note did you document the teach-back?” If it’s not there, that is a finding (a deficiency).

    Step 5: The Report and Correction

    After the survey, you will get a report. It’s rare to have *zero* findings. You will have a “Plan of Correction” (POC) period (e.g., 30-60 days) to fix your deficiencies and submit evidence of the fix. Once you clear the POC, you are awarded your 3-year accreditation.

    2.2.6 Conclusion: Accreditation as a Living Process, Not a Trophy

    Achieving that first accreditation is one of the hardest things a pharmacy will ever do. It requires a complete transformation of the business, from a simple “fill and bill” shop to a data-driven, patient-centric, and highly-documented quality organization. But the work is not over. Accreditation is a 3-year cycle. You are *always* in a “look-back” period.

    This is the *real* value of accreditation. It’s not the certificate you get on Day 1. It’s the culture of continuous quality improvement (CQI) it forces you to adopt on Day 2 and every day thereafter. It creates the infrastructure—the QMC, the metrics, the P&Ps, the RCAs—that gives you, the clinical pharmacist, the tools and the mandate to systematically find problems and fix them.

    As a CASP, you are a leader in this culture. You don’t just “follow” the standards; you *embody* them. You see a patient complaint not as a hassle, but as a data point. You see a dispensing error not as a personal failure, but as an opportunity for a system-wide fix. You are the engine of the quality that these accreditations are designed to certify.