Medical-Grade Refrigeration Can Help Reduce Compliance Risk

Not only are compliance professionals charged with maintaining a safe environment of care, they are among those with the most at stake. So when it comes to vaccination and biologics management, the right medical-grade refrigeration and inventory planning is not just fundamental—it’s critical.

Despite healthcare being the most heavily regulated industry in the United States, proper storage of vaccines, biologics, and other pharmaceuticals still poses a high risk, and regulators are taking notice. What does that mean for Compliance? Quite a bit, turns out—both professionally and personally.

Here’s why: Maintaining drugs and vaccines at proper temperatures is critical for both effective and safe healthcare. So critical, in fact, that improper handling or storage comes with very serious repercussions—from fines, sanctions, and facility closures, to far greater consequences that jeopardize patient safety and cause harm.

“There are few immunization issues more important than the appropriate storage and handling of vaccines.” 

~ 2016 CDC Vaccine Storage and Handling Report

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How do you reduce the risks?

First and foremost, proper refrigeration and inventory management are of critical importance. This depends heavily on acquiring the right assets, including medical-grade refrigerators and biomedical devices, as well as inventory management solutions that track the age of products and continuous temperature readings. In acquiring these assets, you and other key stakeholders should:

 

  • Plan for refrigeration with buy-in from participants in multiple departments and multiple disciplines
  • Get the right equipment in place by working with Engineering and Procurement to conduct research, evaluate needs, coordinate with finance, and solicit the best value
  • Prioritize preventative maintenance / understand manufacturer temperature requirements through education, training, and assignment of responsibilities
  • Maintain control of assets through heightened vigilance, asset protection, and trusted automation

 

Other important aspects of a comprehensive temperature-monitoring and compliance regimen include research, education, training, and maintenance, as well as implementing antifraud, anti-waste, and anti-abuse (anti-FWA) practices. Your role in each is to:

 

Document and Record

To protect facility investments, your job is to ensure that vaccines and drugs are stored properly, and that the process is standard practice. Be prepared to assume primary responsibility for oversight through auditing.

 

Inspect and Assess

Periodic review of the physical office and pharmaceutical storage space is necessary for adherence to policies and procedures. In other words, know what assets you have, note what assets you need, and integration automation and efficiencies however possible.

 

Educate and Train

Safety is everybody’s responsibility, not yours alone. Provide regular education and training to all who handle pharmaceuticals and vaccines. They should know how to safely store the products, and how to properly use the storage devices.

 

Emphasize the Communal Role

Changing or improving compliance policies requires a team effort. Professionals from all segments of healthcare have relevant, empirical knowledge and data to contribute to an organization’s capital acquisition and management methodology. It’s up to you to gather representatives from multiple disciplines and seek out many voices and viewpoints.

 

Determine Trends

Although issues in temperature monitoring may exist, persistent issues lead to trends, and trends lead to systemic compliance problems. You must discern these trends and patterns to determine whether the issues in medication and vaccine refrigeration point to broader compliance failings.

 

Nail these five components to compliance and ensure you refrigeration and vaccine management solution is best suited for the demands of your facility, and you’ll be well on your way toward improved safety and peace of mind.

To read the full primer on temperature monitoring for compliance officers, visit hcca-info.org.

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