CASP Module 27, Section 3: Facility Design for Specialty Operations
MODULE 27: CONSTRUCTION & COMPLIANCE CHECKLIST

Section 27.3: Facility Design for Specialty Operations

Designing physical layouts that support efficient workflows, meet accreditation standards, ensure patient privacy (HIPAA), and incorporate requirements for hazardous drug handling (USP <800>).

SECTION 27.3

Facility Design for Specialty Operations

From Retail Counter to Clinical Operations Hub: A Pharmacist’s Guide to Workflow and Compliance in Physical Design.

27.3.1 The “Why”: A Pharmacy That Isn’t a Store

As an experienced pharmacist, your entire career has been shaped by a specific physical layout: the retail pharmacy. This design is a marvel of efficiency for one specific goal: serving high-volume foot traffic. It’s built around a “front end” (the aisles) and a “back end” (the pharmacy bench), with a counter acting as the transactional barrier. Everything is optimized for a patient to walk in, drop off, shop, and pick up in 15 minutes.

You must now take that entire mental blueprint and throw it in the trash. A specialty pharmacy is not a store. It is a clinical operations hub. 99% of your “patients” will never set foot in your building. Your “customers” are not the people walking in; they are the PBMs, manufacturers, and prescribers you serve on a national scale. Your facility’s design is not meant to impress patients; it’s meant to impress auditors and maximize efficiency.

The layout of your specialty pharmacy is your single greatest asset for achieving efficiency and your single greatest liability in a compliance audit. A poorly designed facility creates bottlenecks, wastes payroll, fails HIPAA audits, and can lead to accreditation denial. A well-designed facility, on the other hand, creates a “workflow engine” that separates tasks, protects patient data, ensures compliance, and allows your team to function at a high level. This section is your architectural guide to building that engine.

Pharmacist Analogy: Building “Mission Control,” Not a “Bus Stop”

Think of your facility design in terms of transportation hubs.

  • A Retail Pharmacy is a Bus Stop. It’s designed for simple, transactional, short-haul “routes” (a 30-day supply of lisinopril). The goal is speed, convenience, and moving the line. The “driver” (pharmacist) does almost everything: takes the ticket, checks the engine, and tells you when to get off.
  • A Specialty Pharmacy is an Air Traffic Control Center (Mission Control). It is not open to the public. It is a secure, high-tech facility designed to manage extremely complex, high-stakes, long-haul “flights” (a $20,000/month oncology patient).
    • You don’t have one “driver.” You have a team of specialists, and each has a dedicated, purpose-built “station.”
    • Intake = Flight Plan Filing: A team in a quiet “data center” receives and processes the initial “flight plan” (the referral) from the “pilot” (the prescriber).
    • Benefits/PA = Customs & FAA Clearance: A separate team of experts works the phones and portals to get “clearance” (prior authorization) and “payment” (benefits investigation).
    • Clinical = In-Flight Monitoring: A dedicated team of pharmacist “controllers” proactively calls the “pilot” (patient) to monitor for “turbulence” (side effects) and ensure they are on the right “flight path” (adherence).
    • Dispensing = Fueling & Final Checks: The pharmacy “bench” is the “ground crew”—a secure area focused only on preparing the “payload” (the drug) with 100% accuracy.
    • Shipping = The Launchpad: A dedicated logistics hub that manages the complex “launch” (cold chain shipping) and “tracking” (delivery confirmation).

You would never design an Air Traffic Control tower with the fueling bay in the middle of the control room. It would be chaotic, loud, and dangerous. By the same logic, you cannot design your specialty pharmacy with the dispensing bench in the middle of your clinical call center. Your layout *must* be built on the principle of workflow separation, creating distinct, purpose-built zones for each of these critical functions.

27.3.2 The Core Principle: Workflow Unidirectionality

Before you draw a single line on a blueprint, you must internalize the foundational concept of industrial design: Unidirectional Workflow. This means that a prescription (and its associated data) should move through your facility in one direction, like an assembly line. It should never have to go “backwards” to get a task done. A “backwards” step is a sign of a broken process and a bad layout.

The Ideal Specialty Workflow (The “Assembly Line”)

Imagine a physical prescription in a tote. That tote should move in a clear, linear path through your building. This minimizes lost paperwork, reduces footsteps, eliminates confusion, and creates clear accountability. A well-designed layout physically enforces this path.

1. INTAKE

Referral Received (Fax/eRx/Phone)

2. BENEFITS (BI/PA)

Data Entry, Auth, & Financials

3. CLINICAL

Pharmacist Review & Patient Counseling

4. DISPENSING

Drug Pulled, Filled, & Checked

5. SHIPPING

Packed, Labeled, & Shipped

The Cost of a Broken Workflow

What happens when you ignore this? Imagine a facility where the Dispensing bench (Zone 4) is placed right next to the Intake team (Zone 1), and the Shipping station (Zone 5) is on the other side of the building.

The result is chaos:

  • The noise from the Intake call center distracts the dispensing pharmacists, increasing the risk of a filling error.
  • The Intake tech, running a fax, has to walk *through* the secure dispensing area, violating compliance and distracting the team.
  • A checked, bagged, and ready prescription (filled in Zone 4) must then be walked 100 feet across the entire building to Zone 5, creating a chain-of-custody risk and massive wasted motion.
  • The pharmacist doing a clinical call (Zone 3) is shouting over the sound of the tape guns from the shipping department. This is a HIPAA violation.

Your physical layout is your primary engineering control for safety, efficiency, and compliance. Designing it correctly from Day 1 is paramount.

27.3.3 Masterclass: Designing the “Zones” of Operation

Let’s build our “Mission Control” zone by zone. We will analyze the Function, Design Priorities, and Accreditation/HIPAA Gotchas for each distinct area.

Zone 1: The Intake & Patient Access “Pod” (The Front Door)

This is the central “funnel” for your entire operation. It is a data entry and call center, and its design must prioritize speed, accuracy, and quiet focus.

Function & Key Components
  • Function: Receive all new referrals from all channels (e-fax, e-prescribe portals, phone, portal) and create the initial patient profile in the pharmacy system.
  • Staff: Intake Coordinators, Patient Access Specialists (often specialized technicians).
  • Key Components:
    • High-Speed Scanners: Do not underestimate this. You will receive 50-page patient charts via fax. You need fast, sheet-fed scanners.
    • Dual (or Triple) Monitors: This is non-negotiable. An intake tech must look at the referral document (Monitor 1) while working in the pharmacy software (Monitor 2).
    • Headsets: Every station must have a high-quality, noise-canceling headset. No speakerphones.
    • Digital Fax Server: A physical fax machine is a HIPAA liability. All faxes should be digital, arriving in a secure, HIPAA-compliant e-fax queue (e.g., RightFax).
    • “Command Center” Monitor: A large, wall-mounted screen showing the real-time status of the intake queue (e.g., “Faxes Waiting: 23,” “Longest Wait: 45 min”).
Design, Layout, & HIPAA Gotchas
Design Priority Practical Application Accreditation / HIPAA “Gotcha”
Acoustic Privacy This is a call center. It must be treated as one. Use sound-absorbing ceiling tiles, commercial-grade carpet, and sound-masking (“white noise”) systems. An auditor (or just another employee) overhearing an Intake tech discussing a new patient’s name, DOB, and diagnosis is a clear HIPAA violation.
Visual Privacy Use high-walled cubicles (at least 60 inches) to block sightlines to monitors. Position all monitors so they face away from any walkways. An auditor walking by and glancing at a screen displaying a patient’s e-referral (ePHI) is a violation. All workstations must be “privacy-enabled.”
Secure Access This area must be behind the first secure, key-card-access door. It is not a public space. Auditors will check your key-card logs. They want to see that only authorized staff (e.g., Intake, Clinical, Admin) can enter this area. The shipping tech should not have access.
“Clean Desk” Policy The physical layout must support this. This means minimal paper, locking drawers at each desk, and no “in-progress” faxes left on desks overnight. The easiest way to fail an audit is to have paper PHI (old referrals, sticky notes with patient names) visible. Auditors love to check this at the end of the day.

Zone 2: The Clinical & Benefits “Pod” (The Professional Office)

This is the “brain” of your pharmacy. It is an office environment for highly sensitive patient conversations. The pharmacists here are not checking prescriptions; they are performing MTM, counseling, and adherence check-ins. The Benefits team is handling complex PA appeals and co-pay assistance. This zone has the *highest* HIPAA sensitivity.

Function & Key Components
  • Function: All patient-facing clinical calls (counseling, adherence), all payer-facing calls (PAs, appeals), and all prescriber-facing calls (clarifications, lab reviews).
  • Staff: Clinical Pharmacists, MTM Specialists, Case Managers, Prior Authorization Specialists, and Co-Pay Assistance Coordinators.
  • Key Components:
    • Private Offices / “Phone Booths”: This is the most critical design element. You need 3-4 small, soundproof “phone booths” or small offices where pharmacists can take sensitive calls (e.g., a new HIV patient counseling) in total privacy.
    • Main “Pod”: The core team can be in a cubicle farm similar to Intake, but it must be physically separate from Intake. These are different workflows.
    • Conference Room: A dedicated “War Room” with a large monitor for reviewing complex cases as a multidisciplinary team (pharmacist, tech, billing specialist).
Design, Layout, & HIPAA Gotchas
  • The #1 Priority: AUDIBLE PRIVACY. A patient must be able to discuss their most sensitive health information without fear of being overheard. A layout that puts the clinical pharmacist pod next to the breakroom or the shipping department is an automatic accreditation failure.
  • Separation of Function: The Clinical team’s calls are long (15-30 minutes). The Intake team’s calls are short (3-5 minutes). Do not mix them. A loud, high-velocity Intake call center will destroy the quiet, empathetic environment required for a clinical assessment.
  • Visual Privacy: All rules from Zone 1 apply, but are even more strict. Screen-privacy filters are a good investment for this area.

Zone 3: The Dispensing & Verification “Core” (The Pharmacy Bench)

This is the “classic” pharmacy, but designed for production, not retail. It is a secure production line. Access must be strictly limited to licensed pharmacists and registered technicians. This is your “clean room” in a metaphorical sense.

Function & Key Components
  • Function: Data entry (if not done in Zone 2), prescription filling, and final pharmacist verification.
  • Staff: Dispensing Technicians, Pharmacists (Verification & Compounding).
  • Key Components:
    • Dispensing Benches: Long, linear counters.
    • Automation: Robotics (like ScriptPro or Parata) for high-volume oral solids. This is a must for efficiency at scale.
    • Verification Stations: Ergonomic “check” stations for pharmacists, set apart from the filling bench to minimize distractions. Must have a scanner, computer, and space for the tote.
    • The “Vault”: A literal, secure safe or cage for Schedule II controlled substances.
    • The “Wall of Totes”: A shelving system that physically separates the workflow:
      • Shelf A: “Ready to Fill”
      • Shelf B: “Ready for Verification”
      • Shelf C: “Verified – Ready for Shipping”
Design, Layout, & Accreditation Gotchas
A dispensing error that occurs because the pharmacist was distracted by other staff walking by is a failure of facility design.
Design Priority Practical Application Accreditation / HIPAA “Gotcha”
Secure Access This is the most secure non-drug area. Access must be restricted to BOP-licensed personnel only. This means your Intake, Clinical, and Shipping staff should not have key-card access to this room. An auditor will check. If your Patient Access specialist (who is not a registered tech) can walk into the dispensing core, you will be cited. This area must be a “pharmacy-within-a-pharmacy.”
Unidirectional Flow The bench layout must be linear. Totes come in one side (Fill) and move to the other (Check). A “checked” prescription should never be able to move “backwards” to the “unchecked” area. Auditors love this. They will ask, “How do you prevent a checked drug from being mixed with an unchecked drug?” Your answer is your physical layout: “Checked drugs are placed on this separate, green-tagged shelf, which is 10 feet away from the fill bench.”
Pharmacist “Cockpit” The verification pharmacist must be able to work undistracted. Do not put the verification station in the main walkway or next to the phone. A quiet “cockpit,” often on a raised platform for better visibility, is ideal.

Zone 4: The Logistics & Shipping “Hub” (The Warehouse)

This is your mailroom and warehouse. It is a high-volume logistics center that manages your entire cold-chain and chain-of-custody process. It must be designed for efficiency, accuracy, and security.

Function & Key Components
  • Function: Securely package verified prescriptions, manage cold-chain shipping supplies, and hand off packages to carriers (FedEx, UPS, etc.).
  • Staff: Shipping Clerks, Logistics Manager.
  • Key Components:
    • Packing Stations: Multiple stations with computers, label printers (for shipping labels), tape guns, and all necessary packing materials (boxes, bubble wrap).
    • Cold Chain Corner: This is the subject of 27.4. It includes your validated refrigerators/freezers, and shelves of pre-prepped Styrofoam coolers, gel packs, etc.
    • “Ready for Pickup” Staging Area: A secure area (preferably a locked cage or room) where sealed, labeled packages are sorted by carrier (FedEx pile, UPS pile) and await pickup.
    • Carrier Pickup Door: Ideally, a dedicated back door for carriers, so they are not walking through your entire facility.
Design, Layout, & Accreditation Gotchas
  • Chain of Custody (The #1 Priority): An auditor’s favorite question: “Show me your handoff.” A pile of packages (containing PHI and high-cost drugs) sitting by an unlocked back door is a critical failure. The handoff must be secure.
    • Good: A locked staging area. The driver rings, your shipping manager unlocks it, scans the packages out, and gets a signature.
    • Better: A “Dutch door” or secure window. The driver never even enters the building.
  • HIPAA on the Box: The shipping label itself is a HIPAA risk. Your design must ensure that these labeled boxes are not visible to unauthorized personnel (like the building’s maintenance staff or another vendor). The secure staging area solves this.
  • Efficiency: This zone must be placed at the end of the unidirectional workflow. The “Verified – Ready for Shipping” shelf from Zone 3 should ideally pass *through* a window into Zone 4, so the pharmacy staff doesn’t even need to enter the shipping area.

27.3.4 Masterclass: USP <800> — Designing for Hazardous Drugs (HDs)

This is the most complex, expensive, and non-negotiable part of modern pharmacy design. If you plan to handle any hazardous drugs (including oral oncology), USP <800> applies to you. This is not a “recommendation”; it is an enforceable standard adopted by most state BOPs and accreditation bodies. Its goal is containment to protect employees and the environment from exposure.

The design requirements are based on the type of HD handling you will perform. This is the first and most important decision you will make.

Decision Tree: Which HD Design Do You Need?
SCENARIO A: “Final Dosage Form” (e.g., Dispensing Ibrance tablets)

You will only dispense final, manufactured dosage forms (tablets, capsules) that do not require any manipulation (no crushing, no splitting, no compounding).

Minimum Design Requirements:

  • 1. HD Receiving: You must have a designated area to receive HDs. You cannot open the HD shipping totes in the main pharmacy.
  • 2. HD Storage: HDs must be stored separately from non-HDs. This means a dedicated, negative-pressure room with at least 12 air changes per hour (ACPH) that is 100% externally vented.
    • This is a major construction requirement. You must build a dedicated room with its own HVAC ducting to the roof.
    • Refrigerated HDs (e.g., some biologic injections) *must* be in a dedicated refrigerator *inside* this negative pressure room.
  • 3. HD Dispensing: You must use a dedicated, cleanable counting tray and spatula for HDs *only*. You must decontaminate the tray after each use.

The Takeaway: Even just *touching* oral oncology tablets requires you to build a dedicated, externally-vented negative pressure storage room. This is a significant cost.

SCENARIO B: “Non-Sterile Compounding” (e.g., Crushing Temodar, making “Magic Mouthwash”)

You will manipulate HDs (crushing, splitting, opening capsules) to make a non-sterile preparation.

Minimum Design Requirements: You need everything from Scenario A, PLUS:

  • 1. A C-PEC (Containment Ventilated Enclosure): This is your “powder hood” (e.g., a Class I Biological Safety Cabinet). It must be 100% externally vented.
  • 2. A C-SEC (Containment Segregated Compounding Area): The room that the hood (C-PEC) lives in. This room must be:
    • Negative Pressure (at least -0.01 inches of water column) to all adjacent areas.
    • Externally Vented (100%).
    • Have at least 12 ACPH (Air Changes Per Hour).
    • Have a “sink and eyewash station” readily available.

The Takeaway: The moment you decide to crush a single Temodar capsule, you have committed to building a full, negative-pressure, externally-vented compounding room with its own expensive hood and HVAC system. There is no middle ground.

SCENARIO C: “Sterile Compounding” (e.g., IV Chemotherapy)

You will prepare sterile HD products. This is the most complex and expensive design.

Minimum Design Requirements: You need everything from Scenario A, PLUS a full USP <797>/<800> compliant cleanroom suite:

  • 1. The C-PEC (Containment-Primary Engineering Control): Your IV hood. This must be a Class II Biological Safety Cabinet (BSC) or Compounding Aseptic Containment Isolator (CACI) that is 100% externally vented.
  • 2. The C-SEC (Containment-Secondary Engineering Control): The “Buffer Room” where the hood lives. This room must:
    • Be ISO 7 clean.
    • Be Negative Pressure (-0.01 to -0.03 in. w.c.) to all adjacent rooms.
    • Have at least 30 ACPH.
    • Be 100% externally vented (cannot recirculate *any* air).
  • 3. The Ante-Room: The “gowning” room. This room must:
    • Be ISO 7 clean.
    • Be Positive Pressure to the general pharmacy.
    • Be Positive Pressure to the C-SEC (the negative buffer room). This ensures that “dirty” air from the pharmacy can’t enter the ante-room, and “clean” air from the ante-room is all that enters the buffer room.
    • Have a “line of demarcation” for gowning.

The Takeaway: This is a multi-million dollar construction project that requires specialized architects and HVAC engineers. The HVAC system is the most complex part, as it must maintain precise temperature, humidity, and differential pressures 24/7. This is the pinnacle of pharmacy design.

27.3.5 Accreditation & HIPAA: The Compliance Overlays

Your layout is not just for you; it’s for the auditors. URAC, ACHC, and The Joint Commission auditors are trained to spot layout flaws. They will walk your facility with a checklist in hand, and they will be looking for failures in Access Control and HIPAA Safeguards.

1. Physical Access Control

You must be able to define and enforce “zones of access.” This is impossible without a modern, auditable key-card system. A “key under the mat” is an automatic failure.

Tutorial: Designing Your Access Control Plan
A physical barrier (a locked, buzzer-entry door) must separate the lobby from all operational areas.
Zone Access Group Design Requirement Auditor’s Test
Lobby / Public Area All Staff, Patients (if applicable), Visitors “Can I walk from the lobby into your call center?” (The answer must be no.)
Zone 1 & 2 (Intake/Clinical) Patient Services Staff, Admin, Pharmacists Key-card access. This is your first secure “bubble.” “Why does the shipping clerk have access to the clinical pod?” (They shouldn’t.)
Zone 3 (Dispensing Core) Pharmacists & Registered Techs ONLY. A second, internal key-card door. This is a “pharmacy-within-a-pharmacy.” “Pull your key-card log for this door. Show me that only licensed staff entered today.”
Zone 4 (Shipping) Shipping Staff, Admin. Key-card access. Must be secure. “Show me your secured cage and logbook for FedEx pickup.”
USP HD Rooms / Cleanroom Trained & Validated Compounding Staff ONLY. Key-card access (or keypad) with an even more restricted access list. “Show me the training and validation file for every person on this access list.”
Server Room / IT Closet IT Staff & Senior Admin ONLY. A dedicated, locked, and climate-controlled room. Not a janitor’s closet. “Is your server (containing all ePHI) in a locked, secured room?”

2. HIPAA Physical & Technical Safeguards

Your layout must be designed to prevent “incidental” HIPAA breaches. An auditor will walk around and look for these specific failures.

Auditor’s HIPAA “Gotcha” Checklist

Walk your own facility and ask these questions. An auditor will.

Visual Safeguards
  • Monitors: Can I see any patient names on screens as I walk the main path? (Fix: Position monitors away from aisles; use privacy filters).
  • Paper: Is there any paper with PHI on a desk, fax machine, or printer? (Fix: “Clean Desk” policy, centralized and secured printers).
  • Disposal: Is that an open trash can next to the fax? (Fix: All paper PHI must go into locked, “pulping” shred bins. No exceptions).
  • Whiteboards: Is that a patient’s name on the whiteboard in the clinical pod? (Fix: All whiteboards must use patient initials or medical record numbers only).
Audible Safeguards
  • Speakerphones: Can I hear a patient’s name being discussed on a speakerphone? (Fix: Total ban on speakerphones in all patient-access areas).
  • “Cross-Talk”: Can I stand in the shipping department and overhear the clinical pharmacist’s counseling call? (Fix: Layout separation and sound-masking technology).
Technical Safeguards
  • Workstations: I see 10 empty desks. Are any of the computers unlocked? (Fix: Enforce a 1-minute auto-locking screen saver via Group Policy).
  • Server Room: Is your server—the box holding 10,000 patient records—unlocked in a closet with the mop bucket? (Fix: Dedicated, locked, climate-controlled server room).

27.3.6 Putting It All Together: Sample Layout Concepts

Let’s visualize how these zones come together in a physical space. The perfect layout ensures security, unidirectional flow, and separation of function.

Layout A: The “U-Flow” (Ideal for ~5,000 – 8,000 sq ft)

This design is perfect for a small-to-medium specialty pharmacy. It uses a single “secure” area and a U-shaped workflow to move a script from start to finish. This is a common and highly efficient layout.

  • Front Door: Public lobby. A single, key-carded door leads into the pharmacy.
  • Left Side (The “Pods”): Immediately upon entry is the Intake Pod (Zone 1). Just behind them, separated by high-walled cubicles and sound-masking, is the Clinical/Benefits Pod (Zone 2). This whole side of the “U” is the carpeted, “quiet” call center.
  • Back Wall (The “Core”): The workflow makes its first turn. The “Verified Totes” from the Clinical Pod (Zone 2) pass to the secure Dispensing Core (Zone 3). This area is a separate, glass-walled room requiring a second key-card access. This is where the dispensing benches, verification “cockpit,” and vault are located.
  • Right Side (The “Hub”): The “Verified – Ready for Shipping” totes pass out of the Dispensing Core into the Shipping/Logistics Hub (Zone 4). This is the “dirty” side—durable flooring, packing stations, and cold-chain supplies.
  • Back Door: At the end of the “U,” the Secure Staging Cage and carrier pickup door are located, ensuring drivers never enter the main facility.
  • USP Rooms: The HD storage and/or compounding rooms are built adjacent to the Dispensing Core, with their own dedicated HVAC.

Benefit: The U-shape is a perfect unidirectional flow. The separation of “quiet” (call center) from “secure” (pharmacy) from “logistics” (shipping) is clear and easy to audit.

Layout B: The “Zoned” Hub (Ideal for 10,000+ sq ft)

For a large-scale national pharmacy, you create physically distinct “buildings-within-a-building,” often separating your high-cost clinical labor from your production labor.

  • Building 1: The “Patient Services Center.” This is a massive, 10,000 sq ft call center. It houses only Zone 1 (Intake) and Zone 2 (Clinical/Benefits). It is a pure, high-tech office space. It is not licensed as a pharmacy.
  • Building 2: The “Dispensing & Logistics Hub.” This is a separate facility (it could be across the street or across the state in a lower-cost area). This building is the licensed pharmacy. It is a pure production and logistics facility.
    • It receives only verified, electronic orders from Building 1.
    • It contains a massive Dispensing Core (Zone 3) with high-speed automation.
    • It contains the large-scale USP Cleanroom Suites.
    • It contains a massive Shipping Hub (Zone 4) that resembles an Amazon fulfillment center, with conveyor belts and dedicated carrier bays.

Benefit: This “Zoned” model provides ultimate separation and scalability. You can build your expensive, highly-regulated pharmacy/cleanroom in one location, while building your (less-expensive) call center in another. This is the model used by the largest national specialty pharmacies.