Section 1: Accreditation Gap Analysis and Roadmap

17.1.1 The “Why”: Translating Accreditation from a Burden to a Blueprint

For many experienced pharmacists, the word “accreditation” triggers an involuntary stress response. You picture mountains of paperwork, clipboards, nit-picky surveyors, and a massive, unfunded mandate that seems disconnected from the actual work of patient care. You’ve spent your career focused on the patient in front of you, verifying prescriptions with clinical precision, and solving complex problems. This new layer of administrative burden feels just like that—a burden.

This section is designed to fundamentally reframe that perspective. The translation of your skills from community or hospital practice to the world of specialty pharmacy accreditation is not about learning a new job; it’s about learning to systematize, document, and prove the high-level work you already do.

Accreditation is not a punishment. It is a blueprint. It is the collected, crowd-sourced wisdom of hundreds of industry experts, payers, and patient advocacy groups, all codified into a set of “best practices.” These standards (from bodies like URAC and ACHC) are not arbitrary rules. They are the essential infrastructure required to manage the most complex, high-cost, and high-touch patients in healthcare. They are the “must-haves” for building a Quality Management System (QMS)—a system so robust that high-quality care and patient safety are the default outcomes, not just the result of a single heroic pharmacist.

In your retail practice, you are the final safety net. In an accredited specialty pharmacy, the system is the safety net, and you are its chief architect and operator. The “Gap Analysis” is the first, and most critical, step in building that system. It’s the process of taking the blueprint (the accreditation standards) and comparing it, line by line, against your current operation to see what’s missing. Without this step, you are building blind, wasting time and resources on things that don’t matter, and missing the critical gaps that will cause you to fail.

This section will provide you with a masterclass in performing this analysis. We will move from the abstract “standard” to the concrete “to-do.” You will learn how to dissect the complex language of URAC and ACHC, create a powerful Gap Analysis tool, perform audits on your own workflows, and, most importantly, build a strategic roadmap that transforms a list of 1,000 “gaps” into a manageable, step-by-step project plan for success.

17.1.2 Deep Dive: Deconstructing the “Big Three” Accreditation Bodies

Before you can perform a Gap Analysis, you must know your “blueprint.” In the world of specialty pharmacy, there are three dominant accreditation bodies. While their standards have largely converged over the years, they each have a different history, “vibe,” and survey focus. Payers (the PBMs and health plans who give you network access) will often require accreditation from one or more of these. Choosing which one to pursue is a critical business decision.

The Players: URAC, ACHC, and The Joint Commission (TJC)

• URAC (formerly Utilization Review Accreditation Commission): URAC is a powerhouse, especially in the payer and PBM world. They started by accrediting health plans and PBMs themselves, so their standards are deeply rooted in process management, data reporting, and organizational structure. They “speak payer” fluently.
• ACHC (Accreditation Commission for Health Care): ACHC has deep roots in community-based care, particularly home health, hospice, and home infusion. Their standards are often seen as more “patient-centric” and clinically focused, with a strong emphasis on the patient’s journey and care coordination.
• The Joint Commission (TJC): This is the 800-pound gorilla of hospital accreditation. If your specialty pharmacy is owned by or embedded within a health system, you will almost certainly be accredited by TJC. Their standards are comprehensive, famously rigorous, and deeply focused on patient safety (e.g., National Patient Safety Goals).

Masterclass Table: Head-to-Head Comparison (URAC vs. ACHC)

For a standalone or independent specialty pharmacy, the choice is almost always between URAC and ACHC. Here is how they compare.

Feature	URAC (Specialty Pharmacy Accreditation)	ACHC (Specialty Pharmacy Accreditation)
Core Philosophy / “Vibe”	Like an “ISO 9000” or business process auditor. Very structured, logical, and process-oriented. They want to see your flowcharts, your P&Ps, and your data. “Do you have a process, do you follow it, and can you prove it with data?”	Like a “clinical peer reviewer.” Very patient-focused and operations-oriented. They want to trace a patient’s chart, interview your staff, and observe your workflow. “How do you take care of this patient, and how does your team work together?”
Key Standards Focus	Patient Management (PM) Program: This is the heart. Requires defined PMPs for specific diseases. Risk Management: Requires a formal Risk Management program, plan, and committee. Data Reporting: Mandates collection and reporting of specific performance measures (e.g., turnaround time, adherence). P&P Structure: Very prescriptive about what your Policies & Procedures must contain.	Patient-Specific Care Plan: This is their cornerstone. A documented, pharmacist-driven care plan for each patient. Clinical Monitoring: Strong focus on initial patient assessment, education, and ongoing follow-up. Patient/Provider Satisfaction: Requires robust systems for collecting and acting on feedback. Rights & Responsibilities: Very strong emphasis on patient communication and advocacy.
Survey Process	Two-part process: Desktop Review: You submit all your P&Ps, flowcharts, and documentation before the survey. A reviewer reviews it all “off-site.” On-Site Validation: A surveyor (or two) comes on-site for 1-2 days to validate that what you wrote in your P&Ps is what you actually do. This is a “prove it” visit.	One-part process: On-Site Survey: A surveyor (usually a pharmacist) comes on-site for 2-3 days. This is the entire review. They will review P&Ps, conduct chart tracers, interview staff, and observe operations all at once.
Why Choose This One?	Payer/PBM Demand. This is the #1 reason. Many of the largest PBMs and health plans specifically require URAC accreditation for network inclusion. Its data-heavy focus aligns with their needs.	Clinical Focus / Infusion. Often preferred by pharmacies with a strong clinical/compounding/home infusion component. It is highly respected and seen as less “corporate” and more “clinical.” It also fulfills payer requirements.

17.1.3 Masterclass: Performing the Gap Analysis (The “How-To” Tutorial)

This is the tactical, step-by-step guide. Performing a Gap Analysis is a massive project, but it is not complex. It is a methodical, granular, and time-consuming process that you must execute with precision. Your pharmacy skills of attention-to-detail and methodical review are perfectly suited for this task.

Step 1: Assemble Your Team and Tools (The “Pre-Work”)

You cannot do this alone. This is not a “pharmacist-only” project. A Gap Analysis that is only performed by the pharmacy manager is guaranteed to fail, because it will miss what actually happens in practice.

Your Core Accreditation Team (The “A-Team”):

• Pharmacist Lead (This is you, the CASP): You are the Project Manager and the Subject Matter Expert (SME) on all clinical standards. You interpret the standards and design the clinical workflows.
• Operations Lead (e.g., Lead Technician, Operations Manager): This person is critical. They know the actual workflow of intake, data entry, filling, and shipping. They know the “workarounds” and the real-world problems.
• Quality Manager (if you have one): This person is the “document controller.” They will manage the spreadsheet, track P&P revisions, and schedule meetings. If you don’t have one, the Pharmacist Lead (you) often absorbs this role.
• IT / Data Analyst: Do not forget this person. Accreditation (especially URAC) has mandatory data reporting. Your IT lead needs to be in the room to answer one question: “Can our system generate a report for that?” If the answer is no, that’s a HIGH priority gap.
• Executive Sponsor (Owner / PIC / Director): This person doesn’t need to be in every meeting, but they must be the one to champion the project, assign resources (e.g., “Yes, we can buy that new software”), and hold the team accountable.

Your Core Tools:

1. The Full, Paid-For Standard: Do not try to do this with a free, public “summary” of the standards. You must purchase the full accreditation manual from URAC or ACHC. This is your blueprint.
2. A Shared Spreadsheet Program: Excel, Google Sheets, or a dedicated project management tool (like Asana or Trello). This will become your “Gap Analysis Tool.”
3. A Central Document Repository: A shared drive (e.g., SharePoint, Google Drive) where all P&Ps, forms, and evidence will be stored. A messy folder structure is an audit failure waiting to happen.

Step 2: The “Read-Through” (The First Pass)

This is the most grueling, but most important, phase. You get your A-Team in a conference room for as many days as it takes. You open the Gap Analysis Tool on the main screen, and you open the Accreditation Manual. You start at Standard 1.

You read the standard out loud. You, as the pharmacist lead, interpret it. “Okay, this standard, SP-PM-02, is our Patient Management Program. It requires us to have a defined program, with written materials, for our top disease states.”

Then you turn to the team and go column by column:

• (Col D) Look-Fors: “Okay, this means we need: 1) A P&P defining the PMP. 2) Patient education materials for each disease. 3) A way to prove we enrolled the patient.”
• (Col E) Current State: Your Operations Lead says, “Well, we counsel all new oncology patients…” You ask, “Is it a ‘program’? Do we document enrollment? Do we have specific materials?” The answer is “No.”
• (Col F) Compliant?: No.
• (Col G) Gap Description: “We perform informal counseling but do not have a formal, documented Patient Management Program (PMP) with defined enrollment criteria, written materials, or follow-up protocols as required.”
• (Col H) Risk Level: HIGH. (This is a URAC core standard).
• (Col I) Corrective Action: “Design and implement formal PMPs for Top 5 disease states (Onc, RA, Hep C, MS, Psoriasis).”
• (Col J) Person Responsible: “Pharmacist Lead (for clinical content) & Quality Manager (for documentation).”

You do this for every single standard. This process can take 40-80 hours. It is a marathon. At the end, your Gap Tool is a terrifyingly long list of “No”s and “To-Do”s. This is normal. This is the *point*. You have successfully defined the scope of your entire project.

Step 3: The “Deep Dive” Audit (The Second Pass)

The Read-Through identified what you think your gaps are. Now you must prove it. You must audit your own processes to confirm the gaps and, more importantly, to find the gaps you thought were “Compliant.”

You will now use the findings from your tracers to update your Gap Analysis Tool. That “Partial” compliant standard on “Clinical Review” is now a hard “No,” and the Gap Description is now “Tracer on 3 of 5 patients showed no pharmacist documentation of clinical review, only a verification check.”

Step 4: The Prioritization (Taming the Monster)

Your Gap Tool is now complete, accurate, and probably 200 lines long. It’s overwhelming. You cannot fix 200 things at once. You must prioritize.

This is the function of Column H (Risk Level). You and your A-Team now have a “Prioritization Meeting.” You sort the spreadsheet by “Risk Level” and “Compliant = No.”

Your “Must-Do-First” (High Risk) Bucket:

• Patient Safety Gaps: Anything related to clinical review, DDI, allergy checks, side effect management, or shipping integrity.
• “Core” Standards: The accreditation manuals will identify “Core” or “Required” standards. A “No” on one of these is an automatic failure. These are your top priority. (e.g., The entire Patient Management Program in URAC).
• Long Lead-Time Gaps: Gaps that take months to fix. Example: “Our software cannot report on patient adherence.” This is a HIGH priority gap because you need to start the process of finding, buying, and implementing new software *today*.
• “Blocking” Gaps: Gaps that prevent other work. Example: You can’t train staff (a Medium risk gap) until you’ve written the P&Ps (a High risk gap).

Your “Can-Wait” (Low Risk) Bucket will be things like: “Our ‘Patient Rights’ document has a typo,” or “Our Quality Committee meeting minutes were filed late one time.” These are fixed in the final “clean-up” phase, not now.

This prioritized list is no longer a “Gap Analysis.” You have just created your Strategic Roadmap.

17.1.4 From Gaps to Goals: Building and Managing the Strategic Roadmap

The Gap Analysis Tool is the what. The Roadmap is the when and who. This is where you transform from a clinical pharmacist into a project manager. Your Gap Tool becomes the roadmap, but you will now manage it like a true project.

Strategy 1: Create Thematic “Workgroups”

You cannot have 10 people all trying to fix 200 gaps. You must divide and conquer. Group your “High” and “Medium” risk gaps by theme and create small, focused workgroups.

Common Accreditation Workgroups:

• P&P Workgroup: (Lead: Quality Manager or You). Task: Take every gap that says “Write new P&P” or “Revise P&P.” They meet weekly and do nothing but write and review policies.
• Clinical / Patient Management (PM) Workgroup: (Lead: You, the CASP). Task: Design the entire clinical experience. This is the biggest, most important workgroup. They will design the disease-specific PMPs, create all patient education materials, build the new EMR forms for documentation, and define the clinical follow-up protocols.
• Data / IT Workgroup: (Lead: IT Manager). Task: Tackle all the data-reporting gaps. They will build the custom reports for adherence, turnaround time, call center metrics, etc. Their work is essential for URAC.
• Training Workgroup: (Lead: Operations Lead or You). Task: This group starts after the P&P and Clinical groups are underway. Their job is to take the new P&Ps and new workflows and create training materials (checklists, PowerPoints) and train all staff.

Strategy 2: Visualize the Timeline (The Gantt Chart)

Your Gap Tool has “Target Dates,” but it’s hard to see the big picture. A Gantt Chart is a simple visual tool that turns your list into a project timeline. This is what you will show to your Executive Sponsor to get buy-in and show progress.

Masterclass Table: Sample Roadmap (Gantt Chart View)

Imagine your target is to “Submit Application” in 12 months (by Q4).

Workgroup	High-Level Task	Q1	Q2	Q3	Q4
Leadership	Complete Gap Analysis & Roadmap
P&P Workgroup	Draft & Approve All Required P&Ps
Clinical/PM Workgroup	Design & Build PMPs and EMR Forms
IT/Data Workgroup	Build & Validate All Data Reports
Training Workgroup	Train All Staff on New Processes
All	“Go-Live” – Operate under new standards
Leadership	Conduct Full “Mock Survey” (Internal Audit)
Leadership	Fix Mock Survey Gaps & SUBMIT APPLICATION

This simple visual shows the dependencies. You can’t “Train Staff” (Q3) until the “P&Ps are Written” (Q1-Q2). You can’t “Go-Live” until staff are trained. This is the essence of project management.

17.1.5 The Pharmacist’s Role: Quarterback, Champion, and Clinical Architect

This entire module may seem administrative, but the reality is that an advanced, certified pharmacist (like a CASP) is the indispensable leader of this entire process. You cannot delegate this to a non-clinical “quality manager.” Accreditation in specialty pharmacy is, at its heart, a clinical validation.

Your role is not just to participate, but to lead from the front in several key domains:

1. The Clinical Architect

The standards (URAC P-PM-02, ACHC PHARM 3-1B) require a Patient Management Program and a Patient-Specific Care Plan. A non-clinical person cannot design this. You are the *only* one on the team who can answer:

• What are the 5 most critical counseling points for a new-to-therapy Oncology patient?
• What specific lab values must we track for a Hepatitis C patient, and at what frequency?
• What is the appropriate side effect management protocol for a patient on an RA biologic reporting an injection-site reaction?
• What adherence barriers are unique to MS patients, and what interventions should we deploy?

You will be the primary author of all your pharmacy’s clinical PMPs, education materials, and pharmacist intervention forms. This is the clinical core of the entire accreditation.

2. The “Standard” Translator

The accreditation manuals are written in dense, administrative “legalese.”

The Standard says: “The specialty pharmacy shall have a documented process for the assessment of patient adherence, persistence, and management of barriers thereto.”

Your Team Hears: “What does that even mean?”

You, the Pharmacist, Translate: “This means we need three things: 1) A new field in the EMR where we document the patient’s adherence (e.g., PDC or ‘patient states 28/30 doses’). 2) A question in our follow-up script that asks ‘Why did you miss those doses?’. 3) A dropdown list of interventions (e.g., ‘Switched to bubble pack,’ ‘Set up text reminders’) that we document after we find a barrier.”

This skill—translating complex requirements into tangible pharmacy workflows—is your most valuable contribution to the Gap Analysis process.

3. The Team Champion and Coach

Accreditation is a massive culture change. Your team, especially technicians and support staff, may see it as “just more work.” They will be resistant to the new forms, new clicks, and new documentation requirements.

You must be the champion who explains the “why” behind every new step. Your retail experience in coaching and communication is key.

• Old Way: “Just check the box that you counseled.”
• New Way (Your Script): “I know this new documentation form is an extra minute per patient, but here’s why it’s critical. When we document the *specific* side effect we counseled on, and that patient calls back, the next pharmacist on duty can see exactly what was said. We’re not just checking a box for the surveyor; we’re creating a safer, more continuous experience for the patient. This is what makes us a ‘specialty’ pharmacy.”

4. The Surveyor’s “Peer”

When the surveyor (who is very often a pharmacist themselves) arrives, they will want to talk to the pharmacists. They will conduct their tracers with you. They will ask you to pull up a patient chart and “walk me through your clinical care process.”

Because you led the Gap Analysis and built the roadmap, you will be able to answer with complete confidence. You won’t just know the *process*; you’ll know the *standard number* that the process is built to address. You will be able to speak their language, connecting your clinical practice directly to the accreditation blueprint you helped implement. This is the final, tangible proof of your mastery.