Is Your Package URAC Compliant?
Today's rapidly evolving healthcare industry is complex, especially when it comes to shipping medications and pharmaceuticals. In addition to FDA rules and shipping carrier regulations, pharma companies should also consider the Utilization Review Accreditation Commission (URAC) standards.
TSS Thermalist
June 30, 2023 | Sustainable Leadership
Today’s rapidly evolving healthcare industry is complex, especially when it comes to shipping medications and pharmaceuticals. In addition to FDA rules and shipping carrier regulations, pharma companies should also consider the Utilization Review Accreditation Commission (URAC) standards.
Just as transparent sustainability practices show eco-conscious customers your company is dedicated to the environment, URAC-compliant practices demonstrate that you are committed to quality and accountability in products that people’s lives depend on.
What is URAC?
Before navigating the accreditation process, it’s essential to understand what the URAC does and the standards it sets. The Utilization Review Accreditation Commission, or URAC, is an organization that facilitates the improvement of healthcare practices by providing healthcare companies with accreditation and certification programs adhering to the highest standards for quality and safety.
URAC standards are built on evidence-based practices created in collaboration with various stakeholders, such as health plans, providers, and associations. URAC differs from other organizations because it is not prescriptive, allowing for additional flexibility to develop quality procedures for your organization. URAC reviewers have clinical experience and training to ensure the accreditation process is accurate and consistent.
Whom Does It Serve?
The URAC establishes standards in the healthcare industry, including means for shipping sensitive healthcare products such as pharmaceuticals. The URAC is the largest among independent healthcare accrediting organizations in the United States and sets guidelines for various specialties worldwide.
The URAC accredits healthcare organizations in the following areas:
- Pharmacies
- Health plans
- Mental health and substance use disorder
- Digital and telehealth
- Administrative management
- Patient care management
URAC accreditation positions you as a leader in promoting safe and effective healthcare practices, improving your commitment to patients, and boosting your company’s reputation within the pharmaceutical shipping sector.
The URAC Accreditation Process
URAC guides the accreditation process to help you navigate the steps toward URAC compliance. The path can be broken down into the steps below.
1
Submitting an initial submission form including essential information for your company, the scope of its services, and corporate governance. The initial submission also includes documentation for your company’s compliance with URAC standards, such as policies, procedures, contact information, program descriptions, and reports. URAC offers a client relations manager and thorough training materials to simplify the process.
2
Application evaluation occurs after your submission. A lead reviewer for URAC will perform a desktop review of your application. This step occurs over 30 days, where the URAC team reads your application, asks clarifying questions, and ensures that documentation demonstrates your company’s compliance with URAC standards.
3
Next, the application undergoes a validation review. Validation involves analyzing your application to determine whether your organization’s policies perform how you claim. This step is completed through an in-person or virtual inspection.
4
Your application is stripped of identifying information, packaged, and shipped to the accreditation committee for adjudication. Following adjudication, applications are awarded one of the following accreditation statuses: full, conditional, or provisional accreditation. If not accredited, your application receives a status for either corrective action or denial.
URAC Resources
URAC provides several resources for organizations to remain compliant and adhere to the best healthcare practices for optimal and continuous care, including accreditation and certification products, conferences, training workshops, on-demand events, and webinars to train your team and educate you on compliance.
Additionally, URAC resources include various publications available through the organization. These publications range from white papers to accreditation guides and online videos explaining the step-by-step compliance and application process. URAC guides healthcare leaders seeking advice on actionable cost-saving strategies and details to comply with state and federal healthcare regulations.
URAC Guidelines for Pharmaceutical Shipping
URAC guidelines prioritize three quality-assurance elements for successful, compliant shipping in specialty pharmacies. Below is a breakdown of these elements:
- Shipping accuracy: A primary goal of the URAC is to ensure that specialty pharmaceutical products are shipped accurately to the intended recipients. Complying with shipping accuracy emphasizes the importance of accurate shipping records, documentation, and processes during the shipping lifecycle. Accuracy also verifies shipping addresses, tracking numbers, and other pertinent information to reduce shipping risks that lead to lost products, delays, or incorrect deliveries.
- Maintaining institution-specific standards: URAC recognizes that different institutions will have additional shipping requirements based on specific needs and regulations.
- Guaranteeing the integrity and stability of pharmaceutical products: The URAC outlines the need for shipping providers to implement measures to ensure the integrity of pharmaceutical products throughout transportation. This precaution includes steps to appropriately package products, temperature control, handling procedures, contamination control, or address product degradation.
Make Sure Your Shipping Solution Is URAC-Compliant
Determining whether your shipping products and protocols are URAC compliant is possible by asking yourself a few questions listed below.
- Does your organization use technology to effectively measure, test, and communicate shipping status for your pharmaceutical products throughout the supply chain?
- Do you implement training for employees to guarantee URAC-compliant practices?
- Do you have a disaster recovery plan in case of unexpected disturbances?
- Do you and your employees understand how temperature, monitoring, and drug efficacy are related?
- Are there issues in your compliance process?
- Are you providing patients and pharmacies with the correct information about the pharmaceutical medications you ship, including storage protocol, handling guidelines, and expiration dates?
- Have you recently had your freezers and refrigerators serviced and checked for proper storage conditions, such as temperature and humidity?
- Do you use cold chain packaging solutions, and what features do these solutions offer? Do they fulfill your requirements for URAC-compliant packaging?
Benefits of Pharmacy Services URAC Accreditation
URAC accreditation goes beyond a commitment to quality and accountability, and there are several other reasons why you might want to consider accreditation for your company:
1
URAC accreditation provides a quality credential to show your organization’s high standards and capabilities.
2
Accreditation provides a consistent, optimized process for patient management, services, and communication performance.
3
URAC accreditation offers a roadmap for continuous improvement within clinical services.
4
Accreditation elevates your company’s contracting power, differentiates you from competitors, and gives you more credibility and authority in the healthcare industry.
5
Accreditation offers peace of mind to healthcare organization leaders by providing standards to prevent, protect, and manage all liabilities.
6
URAC accreditation can inspire healthcare innovation through a unique approach to your company’s practices.
7
Accreditation ensures that you stay on top of industry standards and shifting trends.
8
Accreditation validates URAC compliance with state and federal regulations and other relevant regulatory requirements for your institution.
Tips to Stay Compliant
Once you finish the accreditation process, you must still maintain compliance with URAC industry standards. As the industry shifts and evolves, keep in mind the following tips for organizations to demonstrate to all accredited organizations:
- Familiarize yourself with URAC standards by obtaining a copy applicable to your organization.
- Conduct a thorough gap analysis to identify areas where your organization falls short of URAC standards.
- Have policies and procedures that align with URAC standards and outline employees’ processes, roles, responsibilities, and compliance requirements. Review and update these policies as necessary.
- Have quality improvement initiatives for continuous growth, including frequent audits, data collection, and corrective action when appropriate.
- Offer staff training and provide resources to educate your staff about URAC standards and the importance of compliance.
- Keep documents and maintain your records for all compliance-related activities, such as training, audits, policy revisions, and corrective actions.
- Monitor and measure performance regularly to track your compliance with URAC standards. Monitor your KPIs and assess your performance against these benchmarks.
- Prepare for site visits and audits from URAC professionals by having all required documentation and evidence of compliance readily available. Have staff assigned to assist auditors during the visit for a seamless process.
- Stay on top of URAC changes, including policy updates, newsletters, and other communications that inform you of current URAC requirements. Agree to receive emails from URAC to keep you informed on these updates.
- Seek expert guidance when needed, especially if you find it challenging to interpret or implement specific URAC standards.
How Our Thermalists Can Help
Ensuring your shipping solution is URAC-compliant is crucial to your company’s sustainability and quality. At TSS, our thermal packaging solutions offer precise temperature control and protection that comply with URAC standards. Our team is highly experienced in pharmaceutical shipping, and we’re here to help you navigate the complex world of accreditation, regulations, and certification.
