Section 29.4: Training, Credentialing, and Ongoing Assessment

29.4.1 The “Why”: Training is Your Primary Risk Management Strategy

In your pharmacy practice, what is the single greatest risk? It’s an untrained or incompetent pharmacist dispensing the wrong drug or missing a fatal interaction. The entire infrastructure of your profession—from board exams to licensure to continuing education—is built to prevent this. As a leader building a specialty pharmacy (SP), this risk is magnified a hundredfold. Your “medication errors” are not just dispensing errors; they are $100,000 cold chain failures, missed PAs that delay oncology therapy, and compliance breaches that could cost you your entire payer network.

This is why, in a specialty pharmacy, training is not an “HR function”—it is your primary operational and clinical risk management strategy. An untrained employee is not a “work in progress”; they are a “high-risk medication error” waiting to happen. Just as you would never dispense a high-risk drug without a robust “medication use evaluation” (MUE) and “therapeutic monitoring” plan, you must not deploy a high-risk employee without a robust training and assessment program.

The previous sections (29.1-29.3) gave you the “what”—the org chart, the FTE model, the job descriptions, and the retention plan. This section provides the “how”—the auditable, accreditation-proof system for proving your team is the best in the business. This system is non-negotiable. Accreditation bodies like URAC and ACHC are built on one simple principle: “If it wasn’t documented, it didn’t happen.”

Your training and assessment program is your “paper trail” of excellence. It is your documented proof that you have systematically:

1. Verified every employee is licensed and cleared to do their job (Credentialing).
2. Trained them on every single aspect of their role, from clinical protocols to workflow procedures (Initial Training).
3. Proven they can perform those tasks safely and correctly (Initial Competency Assessment).
4. Ensured they stay up-to-date and have not developed bad habits (Ongoing Training & Assessment).

This section provides the masterclass on building this system from the ground up, translating your core pharmacist skills of verification, education, and monitoring into a world-class workforce development program.

29.4.2 Part 1: Managing Staff Credentialing (The “License Verification”)

This is the foundational layer of your compliance program. A credentialing file is a non-negotiable, auditable file you must maintain for every single employee, from the Director of Pharmacy to the part-time delivery driver. This is not just an HR requirement; it is a fundamental accreditation and legal requirement.

The core principle here is Primary Source Verification (PSV). This means you, the employer, must obtain verification of a credential *directly from the issuing body* (the “primary source”).

The “Accreditation-Proof” Employee Credentialing File

Every employee file must contain, at a minimum, the following documents. This is your master checklist.

Masterclass Table: The Employee Credentialing & Re-Verification Matrix

Masterclass Tutorial: The OIG Monthly Exclusion Check

This is the single most common compliance failure for new pharmacies. The Office of Inspector General (OIG) maintains a list of individuals excluded from participating in federal healthcare programs (like Medicare/Medicaid). If you employ anyone on this list—even a janitor—and bill Medicare for *any* service, your entire pharmacy can be subject to massive fines and exclusion from the program. You MUST check this list monthly for all employees.

29.4.3 Part 2: Designing the Initial Training Program (The “Loading Dose”)

You’ve credentialed your new hire. They are “approved for use.” Now you must administer the “loading dose” of training. This is the 90-day onboarding program we discussed in 29.3, but this section provides the curriculum. This curriculum is the “what” they will learn. Your goal is to move from “unconscious incompetence” (they don’t know what they don’t know) to “conscious competence” (they can perform the job correctly with focus).

Your training program must be role-based (using the JDs from 29.2) and competency-driven (using the frameworks from 29.2). The program must cover four distinct pillars of knowledge.

The Four Pillars of the Initial Training Curriculum

Your 90-day plan must be a formal checklist that includes modules for each of these pillars. The employee and their preceptor/manager sign and date *every module* as it’s completed. This forms the “Initial Training File.”

Masterclass Tutorial: The Training -> P&P -> Competency “Golden Thread”

This is the concept that ties your entire quality program together. An auditor must be able to pull this “golden thread” for any task.

The Task: Packing a refrigerated shipment.
The Auditor’s Request: “Show me how you manage your cold chain.”
Your Response (The Golden Thread):

1. The P&P (The “Standard”): “Here is our Policy & Procedure (P&P) 7.01: Cold Chain Management. It defines our 2-day and 3-day validated shippers and our specific summer vs. winter packing configurations.”
2. The Training (The “Education”): “Here is our Initial Training Checklist for ‘Fulfillment Technician.’ As you can see, line item 12 is ‘P&P 7.01: Cold Chain Management.’ The employee and their preceptor signed and dated this on [Date], verifying they read the P&P and were trained on it.”
3. The Competency (The “Proof”): “And here is our Initial Competency Assessment for that same employee. As you can see, on [Date], my manager performed a Direct Observation (Evaluation Method #2) of the employee packing a test box, and they passed 10/10 steps on the checklist.”

You have just delivered a perfect, unassailable, and “audit-proof” answer. This “P&P -> Training -> Competency” link is the heart of a compliant program. You must build this for *every essential function* defined in your job descriptions.

29.4.4 Part 3: Designing Ongoing Training (The “CE Program”)

Your “loading dose” is complete. Your employee is competent. But the world changes. Payers update policies. New drugs are launched. Clinical guidelines are revised. Your training program must be continuous, just like your own CE requirements. This is your “maintenance dose” of education to ensure your team’s knowledge never becomes sub-therapeutic.

An auditor *will* ask for your Annual Training Plan. You must create this at the beginning of each year. It must be a formal, documented plan, not just a vague idea.

Masterclass Table: Sample “2026 Annual Ongoing Training Plan”

Leveraging Your Partners for Free, High-Quality Training

As a startup, you don’t have a massive training budget. You must be resourceful. Your partners *want* to train you, for free. This is a critical part of your strategy.

• Manufacturer Partners (Drug Reps/MSLs): This is your #1 resource. Your AbbVie rep (Humira/Skyrizi) or Genentech rep (Ocrevus) will pay to have their Medical Science Liaison (MSL)—a PharmD or PhD—come in and provide your pharmacists with a high-level, non-promotional clinical update on their disease state. This is high-quality CE for your team.
• Software Vendors: Your pharmacy software vendor (e.g., CPR+) will have free webinars and update modules. You must assign these to your team and *document* their completion. This is your “Technology” training.
• Wholesaler: Your primary wholesaler (e.g., Cencora, McKesson) has a deep interest in your success. They provide extensive training on cold chain logistics, inventory management (JIT), and DSCSA (pedigree) tracking. Use them.

29.4.5 Part 4: Ongoing Assessment (The “TDM Program”)

You have an annual “CE” plan. Now you need your “TDM” plan. Training (knowledge) is not the same as assessment (skill). You must continuously verify that the training is *sticking* and that your staff is still performing their job safely and correctly. This is your Ongoing Competency Assessment Program.

This is the “Phase IV Post-Marketing Surveillance” from our analogy. You are monitoring your “drug” (employee) in a real-world setting to catch “adverse events” (errors) and ensure “continued efficacy” (competence). This program must be formal, documented, and proactive.

The “TDM” Trifecta: The 3 Assessment Methods

Your annual competency assessment for *every employee* must use a mix of these three methods, which we introduced in 29.2. This is how you build the auditable file.

Masterclass Tutorial: The Proactive “TDM” Feedback Loop

Do not wait until the annual review to do this. That’s like drawing a TDM level once a year—it’s malpractice. A good manager does “TDM” continuously, in small, manageable doses. This is your Quarterly Mini-Audit program.

The Final Step: The Annual Competency File

At the end of the year, you will perform your “formal” annual review. This is now incredibly easy. You simply gather all the documents you’ve been building all year long into one “Annual Competency File” for the employee:

• The Annual “TDM” Summary (your 4 quarterly mini-audits).
• The Annual “Knowledge” Quizzes (HIPAA, Safety).
• The Annual “Direct Observation” checklist (which you did in Q2).
• All “CE” training rosters they signed.

You now have an iron-clad, objective, and auditable record of that employee’s performance, training, and competence for the entire year. You have fulfilled your duty as a manager, a leader, and a compliance officer. This is the gold standard, and it is what separates a “pharmacy” from a “Specialty Pharmacy.”