Handling Facility Compliance for Vaccine Storage Protocols


The regulations for vaccine storage and management can seem complex, but getting and staying compliant is more manageable than you might think. In this article, learn about the requirements for your facility and the solutions that will support best practices.

Vaccines are a central component of preventative healthcare and helping to protect people against communicable diseases. In the context of 2020, vaccine research and studies have become a regular topic in the news cycle. Whether your facility is focused on pediatrics, general care or infectious disease treatment, the protocols for vaccine storage and biosafety should be a top priority. Here we’ll outline the key measures for vaccine management and how automated monitoring can help you maintain and demonstrate compliance.

Best Practice Guidance for Vaccine Storage and Handling

As with many U.S. healthcare protocols, best practice guidelines for vaccine storage and handling can be found at the Centers for Disease Control and Prevention (CDC). But layering on state and local health department immunization programs, manufacturer specifications and emerging research from authorities such as the National Institute of Standards and Technology (NIST) complement (and sometimes, complicate) the CDC’s guidance. Whether just getting started or looking to do a mid-course correction on vaccine storage and handling, there are a few general steps you can take to get going on the right path.

Identifying a designated team member to oversee coordination of your vaccine program will ensure that compliance requirements are understood and implemented. Those requirements should be captured by clear standard operating procedures (SOPs) for vaccine storage and handling. The SOPs will serve as the basis for your facility operations regarding vaccines, and should provide information on types of vaccines, vaccine manufacturers, staff training, storage and handling and also vaccine storage during emergency situations.

Managing the Vaccine Cold Chain

Vaccines require a temperature-controlled supply chain from the manufacturer to the healthcare facility and until they are administered. Within the SOPs for your facility should be an outline of the temperature control requirements for vaccine receiving areas as well as the authorized personnel tasked with receiving and logging vaccine inventory. The conditions will need to be monitored and documented in order to meet regulations and demonstrate compliance.

Primex OneVue Sense provides a solution that can help ensure your SOP is being upheld by monitoring storage conditions with temperature and contact closure sensors. The portable sensors are easily installed and can alert staff to temperature variances, log times of access to restricted areas and capture the monitoring data for on-demand reporting through the OneVue Monitor dashboard.

Routine Vaccine Storage and Handling

After vaccines are received by a facility, measures for temperature control, inventory management and storage monitoring must be maintained. Similar to managing the cold chain, vaccine storage protocols require that the conditions — including temperature, access and duration of storage — need to be monitored and documented. The Primex OneVue sensors can be used to track temperature control, monitor access and store the information to create compliance reports.

Ensuring Compliance in Emergency Situations

Preparedness for emergency situations — such as needing to set up triage or care units in pop-up hospital locations — is a crucial element of well-run healthcare facility operations. However, depending on the severity and duration of an emergency it can be difficult to monitor the integrity of medication and vaccine storage. Primex OneVue takes the worry out of vaccine storage monitoring during emergencies.

Primex OneVue temperature sensors meet the compliance regulations set by the CDC, FDA and other governing bodies. OneVue sensors can be easily installed and moved, and offer multiple power options including battery, AC and power over Ethernet (POE) making them an ideal solution for emergency conditions that might require additional monitoring capacity. The sensors keep data safe by storing readings in local memory during power outages. When systems are back online, the information is sent to OneVue. The units can also be configured to signal local alerts (light and audible alarms) during power and network disruptions.

Automated Monitoring and Biosafety

In addition to protocols for patient safety, vaccine research and use can require additional measures to ensure Biological Safety Levels (BSL) for laboratory and facility personnel. The CDC sets standards for BSL labs in order to assure containment of biological agents. In certain BSL level areas, a key protocol is self-closing, lockable doors.

Primex contact closure sensors can be used to monitor containment measures at a room perimeter or when installed at biological safety cabinets by documenting door contact closure activity. When used as part of the OneVue Monitor software, the sensors act as a line of defense that can confirm the integrity of controlled areas by verifying access against event and treatment logs.

Additional protocols for biosafety, such as USP, can require sustained directional airflow to contain airborne contaminants. OneVue Sense environmental monitoring system uses Differential Pressure Monitoring sensors to detect ultra-low changes in air pressure that could affect biosafety containment areas. The precision of OneVue sensors can detect changes in air pressure and alert the responsible staff through notifications sent by text, phone or email. The system captures pressure-reading data and allows the information to be accessed from anywhere through the web-enabled OneVue Monitor software platform.

Meeting Vaccine Storage and Handling Challenges with Primex OneVue

With Primex OneVue, maintaining vaccine protocol compliance can be done accurately through precision monitoring and thorough documentation. The OneVue suite of environmental monitoring solutions including differential pressure sensors, contact closure sensors and temperature sensors work in tandem with the OneVue Monitor software to produce compliance records and ensure safety. With OneVue Sense, your team can be confident that your vaccine inventory is kept in compliance for effectiveness and safety.

Ready to upgrade your vaccine storage and biosafety system? Reach out for a consultation today!

References

The Standards for Pediatric Immunization Practice (HHS)

National Institute of Standards and Technology: Vaccine Storage and Handling Research (NIST)

USP 800 Compliance: What Your Facility Needs to Know

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