CASP Module 30, Section 2: SOP Tree: Intake → BI/PA → Clinical → Dispense → Ship → Refill
MODULE 30: YOUR GUIDE TO OPERATIONAL INTEGRITY AND MARKET VALIDATION

Section 30.2: SOP Tree: Intake → BI/PA → Clinical → Dispense → Ship → Refill

Architecting your processes: Developing a structured hierarchy (“tree”) of Standard Operating Procedures that logically follows the specialty patient journey.

SECTION 30.2

SOP Tree: Intake → BI/PA → Clinical → Dispense → Ship → Refill

Architecting the DNA of Your Pharmacy: From Patient Journey to Audit-Proof Process.

30.2.1 The “Why”: SOPs as Your Pharmacy’s Operating System

In Section 30.1, we selected our “university.” Now, we must write our “textbooks.” Standard Operating Procedures (SOPs) are the single most important component of your accreditation application and your daily operations. As an experienced pharmacist, you already operate under a set of procedures, but the world of specialty pharmacy accreditation demands a completely new level of formality, granularity, and documentation.

Your community pharmacy workflow is likely a combination of your Pharmacy Management System (PMS) prompts, learned habits, and state laws. It’s efficient, but much of it is implicit—you “just know” how to do it. Specialty SOPs transform this implicit knowledge into an explicit, written, and auditable process.

They are not just “rules to follow.” They are:

  • Your Single Source of Truth: When a new technician asks, “What do I do if a package comes back warm?” the answer isn’t “Go ask Susan.” The answer is “Consult SOP-SHIP-005.”
  • Your Training Manual: This is how you on-board new employees and ensure every staff member performs the same task in the exact same way.
  • Your Scalability Engine: You cannot grow from 100 patients to 10,000 patients based on “what’s in your head.” You can only scale by replicating a defined, optimized, and documented process.
  • Your Accreditation “Study Guide”: During your URAC or ACHC survey, the auditor will hold your SOP in one hand and your patient chart in the other. Their entire job is to find discrepancies between what you *say* you do (the SOP) and what you *actually* do (the chart).
The Accreditation Golden Rule: “If it wasn’t documented, it didn’t happen.”

This is the central mantra of all accreditation. You may have had a life-changing, 45-minute clinical consultation with a patient, but if there is no record of it, no note in the file, and no documentation of the follow-up, it did not happen in the eyes of an auditor.

The second rule is: “If it isn’t in your SOP, you can’t do it.” Conversely, if your SOP says you will call every patient 72 hours after shipment, and the auditor finds a patient you called at 96 hours, that is a *deficiency*. Your SOPs create a contract with the accreditor, and you must prove you are honoring it.

Pharmacist Analogy: The “e-Scribe Workflow” vs. The “Sterile Compounding Formula”

This analogy is critical for you to un-learn your old habits and adopt the specialty mindset.

Your Retail Workflow is an “e-Scribe”: Think about processing an e-prescription for amoxicillin. Your Pharmacy Management System (PMS) is the guide. It prompts you: 1. Input/Verify. 2. DUR Check. 3. Fill. 4. Pharmacist Verify. 5. Bag & Sell. This workflow is linear, efficient, and standardized by the *software*. Your “SOP” is largely to follow the computer’s prompts. It’s safe and effective, but the detailed “how-to” is embedded in the system, not in a 50-page manual.

Your Specialty Workflow is a “Sterile Compounding Formula”: Now, imagine you are preparing a high-risk IV chemotherapy. You would never just “follow the computer.” You use a Compounding Master Formula—your SOP. This document is hyper-granular:

  • Step 1: Perform hand hygiene per SOP-GARB-001.
  • Step 2: Don protective garb in this precise order: shoe covers, hair net, mask, gown, sterile gloves.
  • Step 3: Sanitize the C-PEC hood with Peridox per SOP-CLEAN-002.
  • Step 4: Gather and swab all components. Document all lot numbers and NDCs on this Compounding Log.
  • Step 5: Reconstitute with 9.8mL of sterile water. Withdraw 10mL.
  • Step 6: Have a second pharmacist verify the calculation, the draw-up, and the final volume (the “IV Check”).

This is the mindset you must apply to *every single process* in your specialty pharmacy. Your “Benefits Investigation” SOP must be as detailed as a compounding formula. Your “Refill Call” SOP must have a script as precise as a pharmacist’s final check. You are building a high-risk, high-touch operation, and your documentation must reflect that reality.

30.2.3 Architecting the “SOP Tree”: From Trunk to Branch to Leaf

You cannot just write “an SOP.” A specialty pharmacy will have a *manual* of 50-200 SOPs. The only way to manage this is with a logical hierarchy, or “SOP Tree.” This structure makes it easy for staff to find what they need and for auditors to follow your logic. Your accreditation application will require you to submit an index of your policies, and this tree *is* that index.

Here is the standard, accreditation-ready architecture:

The Specialty Pharmacy SOP Tree

POLICY & PROCEDURE MANUAL (“The Trunk”)

High-level document defining the entire QMS. (e.g., P-GEN-001)

1.0 INTAKE
(P-INT-001)

SOP-INT-001: Referral Intake

SOP-INT-002: Triage & Acceptance

SOP-INT-003: Patient Welcome

FORM-INT-001a: Referral Form

2.0 BI/PA
(P-BI-001)

SOP-BI-001: Benefits Investigation

SOP-BI-002: PA Workflow

SOP-BI-003: Financial Assistance

FORM-BI-003a: Fin. Assist. Screen

3.0 CLINICAL
(P-CLIN-001)

SOP-CLIN-001: Initial Assessment

SOP-CLIN-002: Care Plan Dev.

SOP-CLIN-003: Adherence Mgt.

SOP-CLIN-004: Side Effect Mgt.

4.0 DISPENSE
(P-DISP-001)

SOP-DISP-001: Data Entry

SOP-DISP-002: Product Filling

SOP-DISP-003: Final Verification

LOG-DISP-003a: QRE Log

5.0 SHIP
(P-SHIP-001)

SOP-SHIP-001: Cold Chain

SOP-SHIP-002: Ambient

SOP-SHIP-003: Exception Mgt.

FORM-SHIP-001a: Validation

6.0 REFILL
(P-REFILL-001)

SOP-REFILL-001: Proactive Call

SOP-REFILL-002: Clinical Re-Assess

SOP-REFILL-003: Schedule & Ship

30.2.4 Masterclass: Deconstructing the 6 Main Branches

This is the heart of your manual. Let’s explore the *must-have* SOPs (“leaves”) for each of the 6 main branches (“patient journey steps”). We will detail what the SOP must contain and what the auditor will be looking for.

BRANCH 1.0

Intake (Referral Management)

Philosophy: Your “front door.” The goal is to capture all necessary information to create a patient profile and determine if you can service the patient, all while communicating professionally with the provider.

This is where 90% of downstream errors originate. A “dirty” or incomplete referral creates a cascade of problems for the BI, Clinical, and Dispensing teams. Your Intake SOPs must be designed to ensure 100% data accuracy from the start.

Masterclass Table: Core Intake SOPs
SOP Number & Title Purpose & Key Components Auditor’s Tracer Question
SOP-INT-001: Referral Intake & Data Entry To define the step-by-step process for receiving a referral (fax, e-scribe, phone) and entering it into the system.
Must Include:
  • Mandatory data fields (Patient Name, DOB, Phone, Address, Dx Code, Drug, Prescriber, NPI, etc.).
  • Process for handling *missing* data (e.g., “pended queue,” call to MD office).
  • Timeline: “All referrals must be entered within X hours of receipt.” (e.g., 2-4 hours).
  • Triage: How to identify a STAT referral (e.g., new transplant patient, “Start Today” script).
 “Show me your referral fax log. I see this referral came in at 10:05 AM. Show me in your system when the profile was created. It was missing a diagnosis code. Show me your SOP for handling that and the documentation of your call to the provider to get it.”
SOP-INT-002: Referral Triage & Acceptance To define what referrals you can and cannot accept.
Must Include:
  • Criteria for acceptance (e.g., “Is it a specialty drug? Is it for a disease state we manage? Is it for a payer we can service?”).
  • The “Triage-Out” process: SOP for *transferring* a prescription you cannot fill (e.g., to a competing SP, to the payer’s preferred SP).
  • Timeline: “All triage decisions must be made within X hours.”
 “Show me a referral you rejected this month. Now, show me your SOP for rejections and the communication you sent to the provider *and* the patient explaining where the script was transferred to. How did you ensure continuity of care?”
SOP-INT-003: Patient Welcome & Introduction To define the initial “Welcome Call” to the patient. This is a critical accreditation requirement.
Must Include:
  • The call *script* (e.g., “Hello, this is [Name] from [Pharmacy], we received your prescription…”).
  • A checklist of all items to provide/verbally review (this is a *Patient Rights* standard):
    • Pharmacy services, costs, financial responsibility.
    • Patient’s Rights & Responsibilities.
    • How to file a complaint or report an error.
    • How to get a pharmacist consultation 24/7.
  • How to document patient’s *consent to service*.
 “Pull the chart for this new patient. Show me the documentation of the Welcome Call. How do I know you informed them of their right to file a complaint? Where did you document their consent to receive auto-reminders?”
BRANCH 2.0

Benefits Investigation (BI) & Prior Authorization (PA)

Philosophy: The “Financial Clearance” engine. The goal is to secure a payable claim and ensure the patient has zero financial surprises.

This is the single biggest bottleneck in any specialty pharmacy. Your team here must be expert-level detectives. This is what your retail experience of “PA/Rejection” handling has been preparing you for, now amplified to an extreme degree. A single error here (like not checking the medical benefit) can cost your pharmacy $50,000.

Masterclass Table: Core BI/PA SOPs
SOP Number & Title Purpose & Key Components Auditor’s Tracer Question
SOP-BI-001: Benefits Investigation (Medical vs. Pharmacy) The “Master” BI SOP. Defines the process for determining coverage.
Must Include:
  • The “2-Benefit Check”: Process for *always* checking both the Pharmacy Benefit (running a test claim) AND the Medical Benefit (calling the payer’s medical line).
  • How to use payer portals and other electronic tools.
  • How to calculate patient responsibility (deductible, co-pay, co-insurance, OOP Max).
  • Timeline: “All BIs must be completed within 24 hours of referral.”
 “This patient’s Humira was billed to the *medical* benefit. Show me your SOP that guides a technician on how to check that. Show me the documentation of the call to the payer, including the reference number.”
SOP-BI-002: Prior Authorization Initiation & Follow-up To define the end-to-end PA management process.
Must Include:
  • How to initiate (e.g., CoverMyMeds, Surescripts, payer portal, fax).
  • How to track “pended” PAs.
  • The Follow-up Cadence: This is key. “Staff must follow up on pended PAs every 24-48 hours.”
  • Process for handling *denials* and initiating an appeal.
  • How to communicate status to the provider and patient.
 “This PA was pended for 5 days. Show me your documentation for Day 1, Day 2, Day 3, etc. of your follow-up calls to the insurance and the prescriber’s office. How did you escalate this?”
SOP-BI-003: Financial Assistance (FA) Screening & Enrollment A critical accreditation requirement. You must prove you help patients find financial aid.
Must Include:
  • The “Waterfall”: The logical flow: 1. Apply manufacturer co-pay card. 2. If co-pay is still high (e.g., deductible) or patient is Medicare (co-pay cards are illegal), screen for independent foundations (e.g., PAN Foundation, HealthWell). 3. If patient is uninsured/underinsured, apply for Manufacturer Free Drug (PAP).
  • A script for screening the patient (e.g., “What is your household income and number of dependents?”).
  • How to document all enrollment efforts.
 “This patient’s co-pay was $500. Show me your SOP for financial assistance. Show me the documented FA screening. I see they were enrolled in a foundation. Show me the documentation of that enrollment.”
SOP-BI-004: Communication of Financial Responsibility To define the “financial onboarding” call with the patient.
Must Include:
  • A script for *explicitly* stating the patient’s out-of-pocket cost.
  • How to explain a deductible vs. a co-pay vs. co-insurance.
  • How to get *affirmative consent* from the patient to be billed that amount.
  • How to document this consent in the chart.
 “This patient’s first bill was $2,000 for their deductible. Show me in the chart where you informed them of this exact amount *before* you shipped the drug, and show me where they gave you consent to bill them.”
BRANCH 3.0

Clinical Management (Patient Management)

Philosophy: The “clinical engine.” This is where you prove your value beyond dispensing. This is the #1 focus of both URAC and ACHC surveys.

This department is run by your pharmacists. It is the “Patient Management” (PM) section of URAC and the “Care Planning & Coordination” (CPC) section of ACHC. Your SOPs here must be detailed, evidence-based, and built around proactive patient engagement. This is the translation of your retail “MTM” skills into a high-intensity, longitudinal program.

Masterclass Table: Core Clinical SOPs
SOP Number & Title Purpose & Key Components Auditor’s Tracer Question
SOP-CLIN-001: Pharmacist Initial Assessment To define the *first* clinical call from a pharmacist to a new patient.
Must Include:
  • Who performs it: Must be a Pharmacist.
  • Timeline: “Must be performed within X days of intake.”
  • Content: A full medication reconciliation, allergy review, assessment of baseline disease state, patient-identified goals, barriers to adherence, and co-morbidities.
  • The associated FORM-CLIN-001a: Initial Assessment Questionnaire.
 “I see this is a new patient. Show me the Pharmacist Initial Assessment. Where is the full med rec? Where did you document the patient’s *personal goals* for therapy? I see a barrier was identified (needle-phobia); where is that documented?”
SOP-CLIN-002: Care Plan Development & Monitoring The *output* of the Initial Assessment. A core requirement for both URAC and ACHC.
Must Include:
  • A template for the Care Plan (e.g., Problem/Need, Goal, Intervention, Follow-up Date).
  • How the plan is shared with the patient and prescriber.
  • How the plan is *updated* over time (it’s a “living document”).
  • Example: Problem: Needle phobia. Goal: Patient will self-inject with confidence. Intervention: Pharmacist to conduct live video injection training. Follow-up: Call in 1 week to assess first self-injection.
 “You identified needle-phobia in the assessment. Now show me the Patient Care Plan. Where is that problem, goal, and intervention documented? Show me the documentation of the injection training and the 1-week follow-up call.”
SOP-CLIN-003: Proactive Adherence & Side Effect Monitoring The “TTM” or “MTM” engine. The proactive follow-up calls.
Must Include:
  • Disease-Specific Protocols: You must have separate protocols (or “call scripts”) for different diseases.
  • RA Script: “How is your morning stiffness? Any new infections?”
  • Oncology Script: “How is your fatigue? Any nausea? Have you had your labs drawn?”
  • Call Cadence: “Pharmacist call at 1 month, 3 months, 6 months. Technician call at every refill.”
 “This patient is on a new oral oncology drug. Show me your Oncology protocol. I see it requires a 7-day, 14-day, and 30-day pharmacist call. Show me the documentation for all three of those calls.”
SOP-CLIN-004: Coordination of Care (Provider Communication) To define how and when you communicate *back* to the prescriber.
Must Include:
  • Triggers for *immediate* communication (e.g., severe ADR, non-adherence, hospitalization, pregnancy).
  • Process for *routine* communication (e.g., sending a “Patient Status Summary” fax/EHR message after the 1-month and 6-month assessments).
  • The FORM-CLIN-004a: Provider Communication Note template.
 “This patient reported severe nausea on the 7-day call and you recommended an anti-emetic. Show me your SOP for this. Now show me the fax or EHR note you sent to the prescriber *that same day* to notify them of this ADR and your recommendation.”
BRANCH 4.0

Dispensing (Pharmacy Operations)

Philosophy: “100% Accuracy, 100% of the Time.” This is your core pharmacy workflow, optimized for zero errors.

This is your traditional comfort zone, but now every step is formalized. The specialty dispensing process is often less automated than in high-volume retail. It’s a manual, high-touch process that demands meticulous checks and balances.

Masterclass Table: Core Dispensing SOPs
SOP Number & Title Purpose & Key Components Auditor’s Tracer Question
SOP-DISP-001: Prescription Data Entry & Clinical DUR To define the “front-end” of the dispensing process.
Must Include:
  • Process for transcribing the script and validating all components (drug, sig, qty, refills, prescriber).
  • The *first pharmacist check* (RPh #1) of the data-entered script against the original hard copy.
  • The *clinical DUR* process: How the pharmacist checks for drug-drug interactions, drug-disease contraindications, therapeutic duplications, etc.
 “Show me the original faxed script. Now show me the data-entered script in your system. Who was the first pharmacist to verify this data entry? Where is their electronic signature? What interactions did the system fire, and how did the RPh adjudicate them?”
SOP-DISP-002: Product Filling, Labeling & Staging To define the technician’s workflow for physically filling the prescription.
Must Include:
  • “Scan-to-Fill” Requirement: Mandate that the technician *must* scan the stock bottle NDC to verify it matches the label NDC.
  • Labeling requirements, including all state-law requirements and necessary ancillary labels (e.g., “Refrigerate,” “Chemotherapy,” “Do Not Stop Taking”).
  • A “staging” process: How the filled vial, the stock bottle, and the original script are all placed together in a tote for the final check.
 “Walk me through your filling station. A tech just filled this. How do I know they used the right stock bottle? Show me the scan-to-fill log in your system. What ancillary labels does your SOP require for Humira?”
SOP-DISP-003: Final Pharmacist Verification The “back-end” or “final-eye” check. This is the most critical safety step.
Must Include:
  • Who performs it: Must be a Pharmacist.
  • What they check: The SOP *must* require the RPh to check the final filled vial/pen against the dispensing label, the stock bottle NDC, and the original hard copy prescription.
  • How the RPh documents their verification (e.g., electronic signature, initials on the label).
 “Who was the final pharmacist on this script? Show me your SOP for this step. Does it require them to check the original image? Okay, now show me in the system log where RPh [Name] completed this final check. What time did it happen?”
BRANCH 5.0

Shipping (Logistics & Cold Chain)

Philosophy: The “Last Mile” is the most dangerous. The goal is 100% product integrity from your fridge to the patient’s fridge.

This is a massive area of risk and auditor focus. You are not just a pharmacy; you are a logistics company. You are responsible for that $50,000 drug until the patient signs for it. Your SOPs must be meticulous, and your documentation (especially for cold chain) must be flawless.

Tutorial: Cold Chain Validation 101

You cannot just “guess” your pack-out. Accreditation requires that you *prove* your cooler, gel pack, and dunnage combination works. This is called a Validation Study.

How to do it (Simplified):

  1. Get a Data Logger: A small USB device that records temperature every few minutes.
  2. Define Your “Profiles”: You must test for the worst-case scenarios:
    • Summer Profile: High ambient heat (e.g., 95°F / 35°C) for 48 hours.
    • Winter Profile: Low ambient cold (e.g., 14°F / -10°C) for 48 hours (to prove it doesn’t *freeze*).
  3. Run the Test: Place the data logger in your standard cooler with your standard gel packs and place it in a temperature-controlled chamber (you can outsource this to a lab or buy your own).
  4. Get the Report: The test will generate a report showing the temperature inside the box over the 48-hour period. If it stayed within 2°C-8°C, that pack-out is *validated*.

You must have these validation reports on file. The auditor *will* ask for them.

Masterclass Table: Core Shipping SOPs
SOP Number & Title Purpose & Key Components Auditor’s Tracer Question
SOP-SHIP-001: Cold Chain Packaging & Validation To define the *exact* pack-out for refrigerated (2-8°C) medications.
Must Include:
  • The specific cooler (model #), gel packs (type, size, number), and dunnage (e.g., bubble wrap) to be used.
  • Diagrams showing *how* to place the gel packs (e.g., “gel packs on bottom and top, drug in middle”).
  • Reference to the Validation Study Reports (see above).
  • Ancillary labels: “Refrigerate Upon Arrival.”
 “Show me your validation study for your 48-hour summer pack-out. Now, let’s watch your shipping tech pack this order. Your SOP says 3 gel packs, but they only used 2. That is a deficiency.”
SOP-SHIP-002: Ambient & CRT Packaging To define the pack-out for Room-Temp (20-25°C) and Controlled Room-Temp (CRT) drugs.
Must Include:
  • Pack-out for standard ambient drugs (e.g., box, dunnage).
  • Pack-out for CRT drugs (often requires an insulated cooler *without* gel packs to protect from weather extremes).
 “This oral oncology drug is CRT. Show me your SOP for packing it. How do you protect it from freezing on the patient’s porch in winter?”
SOP-SHIP-003: Shipping Exception & Delay Management To define your *proactive* monitoring process.
Must Include:
  • Process: “Staff must run a report of all shipped packages every morning.”
  • How to identify delays (e.g., “Weather Delay,” “Out for Delivery” for >8 hours).
  • Intervention workflow: 1. Call carrier (FedEx). 2. Call patient to notify them of the delay. 3. Document all actions.
 “This package was delayed by 24 hours. Show me the documentation of your proactive call to the patient *before* they called you. What was your action plan?”
SOP-SHIP-004: Handling Patient-Reported “Warm” or “Damaged” Packages To define your response to a product integrity complaint.
Must Include:
  • The investigation script: “What time did you get it? Were the gel packs still cold? Was the box damaged?”
  • Stability Data: How the pharmacist uses manufacturer excursion data to determine if the drug is stable. (e.g., “Humira is stable at room temp for 14 days”).
  • The reshipment process.
  • How to document this as a patient complaint/QRE.
 “This patient called to report a warm package. Show me your SOP. Where is the pharmacist’s note documenting their stability assessment and the decision to reship? Show me where this was logged as a complaint.”
BRANCH 6.0

Refill Coordination & Scheduling

Philosophy: “Proactive, Not Reactive.” This is the engine of adherence. Never, ever let a patient run out of medication.

This is far more than just “running the refills.” This is a clinical and logistical checkpoint that happens every 30 days. It’s your single greatest opportunity to check for adherence, side effects, and re-verify all shipping and financial information. Accreditation bodies have zero tolerance for “auto-shipping.”

“Auto-Ship” is Forbidden. “Affirmative Consent” is Mandatory.

You cannot, under any circumstances, run a patient’s credit card and ship them a $10,000 drug just because “they were due for it.” This is called “auto-shipping” and is a massive compliance violation.

Accreditation (and many state laws) require “Affirmative Consent” for every single refill. This means you must make contact with the patient (or their designee) *before each shipment* to confirm:

  1. They still need the medication.
  2. The dose and directions have not changed.
  3. They are ready to receive the shipment at their confirmed address.
  4. They agree to the co-payment.
Your SOPs *must* be built around this principle.

Masterclass Table: Core Refill SOPs
SOP Number & Title Purpose & Key Components Auditor’s Tracer Question
SOP-REFILL-001: Proactive Refill Scheduling Call To define the process for initiating the refill.
Must Include:
  • The trigger: “System will generate a refill reminder X days before patient’s ‘out’ date.” (Usually 7-10 days).
  • The call script for the “Refill Coordination Call.”
  • The attempt cadence: “Staff must make at least 3 attempts on 3 different days before closing the task.”
 “Show me your refill queue. This patient is due in 8 days. Show me your SOP for when this call should be made. I see one call attempt yesterday. Show me your SOP for follow-up attempts.”
SOP-REFILL-002: Refill Clinical Re-Assessment To define the “mini-clinical check” that happens on every refill call.
Must Include:
  • A *required script* for the technician or pharmacist:
    • “Have you had any new hospitalizations or ER visits?”
    • “Have any of your medications changed?”
    • “Are you having any new side effects?”
    • “How many doses have you missed in the last 30 days?”
  • Triggers to escalate to a pharmacist (e.g., “Yes, I was in the ER,” “Yes, I missed 5 doses”).
 “Pull the chart for this patient’s refill last month. Show me the documentation of the refill call. Where did the tech document the adherence and side effect re-assessment? The patient reported missing 6 doses; show me where this was escalated to a pharmacist.”
SOP-REFILL-003: Refill Scheduling, Consent & Confirmation To define the final step of getting “Affirmative Consent.”
Must Include:
  • Final verification of shipping address.
  • Final verification of delivery date.
  • Final verification of co-pay amount and consent to charge.
  • A final system note: “Patient confirmed all details, consents to ship on 10/27 for $50 co-pay.”
 “Show me the note in this patient’s chart that proves they gave affirmative consent for their last shipment. Where did they confirm the address and the co-pay? If this was done via your app, show me the electronic log.”

30.2.5 Conclusion: Your SOPs Are a Living Document

You have just architected the operational DNA of your pharmacy. This “SOP Tree” is the single most valuable asset you will create for your accreditation journey. It is massive, complex, and will take your team months to write, review, approve, and train on. And it is worth every second of the effort.

This manual is not a “one and done” project. It is a living, breathing document. Accreditation standards require you to have an SOP for *reviewing your SOPs*. You must have a policy stating that “All SOPs will be reviewed at least annually, or whenever a process changes.”

Your SOP tree is your playbook for new-hire training. It’s your objective standard for performance reviews. It’s your defense in an audit. And it’s your study guide for the accreditation survey. In the next section, we will discuss how to build the “Quality Program” that reads this “textbook” and measures how well your pharmacy is performing against it.