Expert Insights: Why Specialty Pharmacies Fail Accreditations and How to Prevent It

This article was developed by Quintin Jessee, D2's Vice President of Specialty Services & Accreditation with over 25 years of industry & accreditation expertise.

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With over 25 years of experience managing accreditations, I have witnessed a broad spectrum of successes and challenges in the field. My journey began at BioScrip, where I led the accreditation efforts for the organization. Subsequently, I joined D2 Solutions, contributing to the development of their consulting services and assisting over 300 organizations achieve their accreditation goals.

In this article, I aim to share personal insights into the reasons why organizations fail to receive their accreditations and reaccreditations. While the focus is on specialty pharmacy accreditation, the principles discussed also apply to other accreditation types, including Mail Order, Infusion, PBM, and Compounding.

The Importance of Accreditation

Accreditation is a process that officially recognizes a pharmacy as qualified to perform particular activities, aiming to improve patient outcomes and encourage best practices. Specialty pharmacies often seek accreditation from bodies like URAC, the Accreditation Commission for Health Care (ACHC), The Joint Commission (TJC), and the National Association of Boards of Pharmacy (NABP).

Each of these agencies has unique reporting requirements and focuses on different business aspects:

• URAC: Emphasizes patient assessments, clinical interactions, quality management, cold chain and room temperature shipping compliance, distribution accuracy, and prescription turnaround time.
• ACHC: Focuses on organizational structure, patient care outcomes, risk management (infection and safety control), quality management, and fiscal and human resources management.
• TJC: Emphasizes patient safety, quality of care, medication management, infection prevention, and emergency preparedness.
• NABP: Focuses on compliance with state and federal regulations, auditing dispensing processes, and ensuring prescription accuracy.

The Accreditation Process

The accreditation process typically involves an in-depth review of the company's standard operating procedures and an on-site or virtual inspection. Representatives conduct employee interviews and perform physical inspections of the facilities. Some accrediting bodies, like ACHC, may conduct surprise inspections due to CMS requirements for deeming status accreditations.

Pharmacies must ensure they consistently adhere to the accrediting body's standards of care, as accreditation inspections are designed to verify compliance. Any deviation from these standards or inability to provide the required data can lead to a failed accreditation inspection. Therefore, pharmacies seeking accreditation or reaccreditation should familiarize themselves with the accrediting body's requirements and ensure they are consistently meeting these standards.

Common Failures in Accreditation & Reaccreditation

From my experience, the most common reasons for accreditation fall under three major categories:

Record Keeping

"If it isn’t documented, it didn’t happen."

This is a saying I hear frequently in the accreditation world - and it's true. Organizations often struggle to find the documentation needed as evidence of their compliance.

One recurring issue I see when clients fail their accreditation is missing HR files, including primary source verification documentation and date-stamped licensure or certifications for their staff. I frequently see organizations fail accreditations due to missing patient assessments and proper patient interaction documentation as well. Even though these activities may have been performed with the patient, they weren’t tracked or documented appropriately and therefore resulted in a failed accreditation or reaccreditation attempt.

Staff Changes

I've frequently seen changes in accreditation staff lead to failures. When someone with all the accreditation knowledge leaves the organization without a proper transition plan, accreditation tasks are missed and gaps in compliance occur. These gaps may require multiple corrective action plans (CAPs) to fix, which in turn feeds the third area I commonly see failures occur.

Failure to Follow Up on CAPs

Once CAPs are approved by an accreditation body, organizations frequently struggle to follow up on them. Without proper follow-up organizations can't ensure their fix is working and the initial problem may resurface during the next inspection, This is a hard failure to fix and has often resulted in an accreditation being taken away from an organization.

Recommendations for Maintenance & Success

To make sure you successfully achieve and maintain specialty pharmacy accreditations, I recommend keeping these three things in mind:

1. Develop an Accreditation Plan Early On

Establishing an accreditation plan from the beginning is crucial for staying on top of requirements and avoiding last-minute scrambles. By planning early, you can systematically address each accrediting body’s standards and keep your processes aligned with their expectations. This proactive approach not only helps you stay ahead but also ensures that you are well-prepared for any upcoming audits or inspections. It's worth the time.

2. Have a Contingency Plan for Your Staff

Relying heavily on individual team members can be risky, especially when it comes to accreditation. To mitigate this risk, develop a comprehensive contingency plan for staff transitions. This includes documenting procedures, cross-training employees, and ensuring that knowledge about accreditation requirements is shared across the team. By having a robust backup plan or accreditation technology to support your processes, you reduce the likelihood of compliance gaps if key personnel leave or are unavailable.

3. Get Consulting Support When You Need It

Consulting with an accreditation expert can provide valuable, tailored guidance for your specific situation. I recommend choosing a consultant who is reputable and has a proven track record of success in the field. At D2 Solutions, we specialize in URAC, ACHC, NABP, TJC, and NCQA accreditations and have been assisting clients with their accreditation needs for over 12 years. Our team offers robust, personalized consulting expertise and proven technology solutions designed to manage accreditation processes effectively, enhance compliance, and improve results. Don’t wait until issues become critical—reach out to experienced consultants early to address challenges and ensure a smooth accreditation journey.

Learn more about how D2 can support your accreditation journey ?

Let's shape the future of healthcare delivery - together.

As a team of former pharmacists and healthcare leaders, our mission at D2 Solutions is to help you increase efficiency, minimize risk, and drive access so you can focus on what matters most: providing the best care to your patients.

We have spent over a decade developing the consulting and technology solutions we wish we’d had access to when we faced hurdles of regulatory compliance, managing multiple accreditations, expanding pharmacy services, etc.

For more insights on optimizing your pharmacy operations or how D2 can best support your organization, schedule a time to connect with me or contact me directly at [email protected].

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