FLU Season: Maintaining Vaccine Efficacy At Mass Vaccination Events

Flu season is upon us! According to the Centers for Disease Control and Prevention (CDC), seasonal flu activity can begin as early as October and last until as late as May, with peaks typically between December and February.

Health care facilities—as well as many pharmacies, grocery stores, schools and workplaces—often offer free or low cost “mass vaccination” events at the start of flu season.

In early November, I took my family to an off-site flu shot event offered through our healthcare provider. When we got to the front of the line, I noticed that the vaccines were stored in a portable red cooler. It was the same type of cooler we use for barbeque parties and camping trips.

That got me wondering about whether flu shots stored in a camping cooler would actually protect us.  

Vaccines are extremely temperature sensitive. Proper storage and reliable temperature monitoring is critical for maintaining the integrity of the vaccine. CDC guidelines state that vaccines must be stored properly “from the time they are manufactured until they are administered” and warns that “exposure of vaccines to temperatures outside the recommended ranges can decrease their potency and reduce the effectiveness and protection they provide.”  

There’s no doubt that mass vaccination events do a great public service. Indeed, the number of people who get an annual flu shot is greatly increased due to such events. And when more people get vaccinated against the flu, less flu can spread through the community.

So, what’s the best way to store vaccines during off-site events and clinics? Here’s what the CDC recommends:

  • If a properly functioning storage unit is not available, vaccine may be maintained in a properly conditioned insulated cooler.

  • The containers should remain closed as much as possible.

  • Only the amount of vaccine needed at one time should be removed for preparation and administration.

  • A calibrated thermometer (preferably with a biosafe glycol-encased thermometer probe) should be placed as close as possible to the vaccines within the container.

  • At a minimum, temperature readings in the insulated cooler should be read and recorded prior to leaving the provider’s main office, upon arrival at the vaccine administration clinic location, every hour during the vaccine administration clinic session, upon completion of the vaccine administration clinic session, and after return to the main office. Checking and recording the temperature in storage containers ensures that if temperatures are increasing or decreasing over time, providers can intervene before the vaccine is exposed and potentially wasted.

For the 2015-2016 flu season, manufacturers have projected they will provide between 171 to 179 million doses of vaccine for the U.S. market. Have you had yours?

Clearing the AIIR about the Ebola Scare

The monitoring and management of hospital personnel potentially exposed to patients with Ebola Virus Disease (EVD) has brought a renewed focus to the protocols, equipment and isolation rooms used in these quarantine situations. Although Ebola is not considered an airborne disease, the Centers for Disease Control (CDC) recommends that healthcare facilities restrict certain procedures and treatment for Ebola patients to a private room – ideally an Airborne Infection Isolation Room (AIIR) – when feasible.

In a healthcare facility, control of airborne contaminants is essential to providing a safe, healing environment. Yet many healthcare facilities today still rely on smoke tubes or flutter strips to check the airflow and differential pressure of critical healthcare areas, including the AIIRs being used when treating certain infectious diseases. This despite guidelines from the CDC, Joint Commission and ANSI/ASHRAE/ASHE that call for permanently installed monitoring devices for more precise control and safety.

With the Ebola scare, hospitals around the country are quickly realizing they need to adopt a more consistent, continuous, automated method of monitoring for CDC compliance, not only for Ebola, but also for patients with serious, communicable airborne diseases.

The challenge is time. Installing most environmental monitoring systems often requires additional transmitters, bridges or other hardware in addition to the installation of the sensors themselves. However, customers using or adopting the SNS™ platform are leveraging their existing network infrastructure for continuous monitoring simply by adding SNS™ Differential Pressure Monitoring sensors, one of several Wi-Fi based indoor air quality sensors from Primex Wireless.

As your organization considers its differential pressure monitoring situation going forward, Primex Wireless is here to help. Below is a list of reference websites and a link to guidelines for using differential pressure monitoring to protect patients, caregivers and visitors.

The 2013 USP Compliance Study

The results of the 2013 USP Chapter <797> Compliance Study show hospital pharmacies continue to struggle with USP Chapter <797> compliance. While a majority of respondents believe USP <797> is a valuable standard of practice that should be implemented, financial/budgetary restrictions and physical plant limitations are considered to be the primary barriers to adoption of all the guidelines.

The national study of sterile compounding practices has been conducted for the last three years by Pharmacy Purchasing & Products Magazine in partnership with CriticalPoint, LLC. The 2013 study included 1,045 participants, 76 percent from hospital pharmacies. In addition to the questions that measured compliance to 36 specific domains, participants were asked to provide feedback regarding the drivers and barriers to adoption of the USP <797> guidelines.

Differential Pressure Compliance Lags
One of the areas that received low scores on the survey is airflows and pressure differential monitoring. USP <797> has specific requirements for pressure differential monitoring, maintenance and documentation. Yet when study participants were asked the following question, only 56.6 percent gave an affirmative answer:

“There is evidence that mechanisms exist to report excursions, repair defects, and document actions taken as a result of any out of limit pressure/airflow condition until resolution.”

The number of respondents in compliance is up from 49.8 percent in 2011, but is down from the 2012 results of 59.8 percent.

Monitoring airflows is a fairly simple way to decrease the incidence of airborne contaminants in sterile processing areas. Continuous monitoring with audible, visual and email notification capabilities can detect changes in pressure differentials as soon as they occur and automatically alert the proper personnel to take action. Pharmacy personnel do not have to take manual readings several times a day and can concentrate on more valuable tasks. If pressure differential excursions do occur, they are immediately detected, reported and documented in complete compliance with USP Chapter <797>. Compare the features of SNS Differential Pressure Monitoring to the requirements of USP <797> and other regulatory agencies »

Visit the Pharmacy Purchasing & Products website to read the full results of the 2013 USP <797> Compliance Study »

To access the free Gap Analysis tools and receive a free action plan to improve your USP <797> compliance, visit CriticalPoint, LLC »

Part II: Manual Temperature Monitoring is Breaking Budgets

Hospitals and healthcare facilities that manually monitor the temperature and humidity of medical refrigeration units face the risk of losing thousands of dollars of inventory in only minutes if the units fail. A 24/7 automated sensor monitoring system with alerting features is the answer to the three challenges of manual temperature monitoring identified in a recent Primex Wireless survey of healthcare executives: Proximity, Budget Restrictions and Timely Compliance.

Budget Restrictions

The Joint Commission, a nonprofit organization that accredits more than 20,000 healthcare organizations and programs in the United States, assumes that hospitals have the staff level to check medical refrigeration units twice a day. However, today’s budget constraints rarely allow administrators to justify hiring staff solely for manual temperature monitoring. According to the recent Primex survey referenced in my last article, 65 percent of hospital facilities managers reported they feel staffing for manual temperature monitoring is inadequate, and, in turn, more than three quarters of respondents anticipated compliance issues in the next two years.

As with proximity challenges, the solution to budget restrictions is a 24/7 automated sensor monitoring system with alerting features for when temperatures stray out of range.

In fiscal terms, an automated system simply takes fewer people to operate. Furthermore, the savings in staff costs are not shifted to IT expenses. An automated system, such as the Primex Wireless SNS Temperature Monitoring solution, maximizes a hospital’s existing IT investments, carrying data securely over existing Wi-Fi and Ethernet connections. In most cases, the system shouldn’t require any additional network equipment. All data is consolidated in a centralized repository allowing staff in various locations access to the same information from any computer with access to the network and the Web-based interface.

The bottom line is large budgets for temperature monitoring are no longer necessary, and the savings don’t stop there. An automated system with alerting reduces the risk of losses of sensitive medical inventories to virtually zero. Plus, all the staff time once spent on a manual system is now allocated to patient care, where it should be. This means less money spent on staffing for manual checks and more money spent doing what hospitals do best: Care for patients in the best possible way.

Part I: Refrigeration Woes Leave Healthcare in the Cold

We recently polled Facility, Environment of Care and Compliance Managers at hospitals and healthcare facilities about the effectiveness of manual processes for monitoring temperature levels in medical refrigeration units. Their responses led me to two main conclusions: Manual monitoring can lead to losses of medical inventory; and, Risk & Compliance Managers are worried the situation will cause regulatory compliance issues.

Managers can remove the risks associated with manual processes by automating sensor monitoring for medical refrigeration units. In this 3-part series, I explore why and how.

When we asked Facility, EC and Compliance Managers at hospitals and healthcare facilities about the effectiveness of manual monitoring for medical refrigeration, three of five reported the loss of medical inventory, such as vaccines or drugs, due to out-of-range temperatures. They also told us the situation makes them nervous. More than 80 percent said they are concerned about manual monitoring of temperature and humidity levels of refrigeration units. More than 75 percent of that same group feels manual monitoring will cause a regulatory compliance issues in the next two years.

In my professional opinion, these managers have good reason for anxiety because the manual process of checking medical refrigerator units comes with three considerable challenges: Proximity, Budget Restrictions and Timely Compliance. The solution to each problem is the same: A 24/7 automated sensor monitoring system with alerting capabilities.

Proximity

While some refrigeration units tend to be close to areas of patient care, such as an Intensive Care Unit (ICU) or Neonatal Care Unit (NICU), they also are in basements or storage areas. Staying current with every check for every refrigerator requires more resources and time than the facility staff can spare. The clinical team – primarily nurses – is tasked with checking and recording temperatures. While a workable solution, it’s certainly not ideal because clinical staff members are distracted from their primary job – patient care. If a medical refrigeration unit fails when staff isn’t able to break away from patient care, or if staff members are not near the unit for any other reason, thousands of dollars of medical inventory could be lost.

Additionally, a campus could have multiple locations that are short-staffed (or not staffed at all) during non-peak times, such as weekends. With short failure windows, only minutes need pass for thousands of dollars of medical inventory to be lost when a refrigerator fails and no one is in the vicinity to notice.

With an automated monitoring system, the distance issue dissolves immediately. Devices on units leverage existing Wi-Fi networks to monitor and track temperatures, regardless of where units are located in the hospital or even the entire campus. Alerts can be configured for immediate notification when high or low thresholds are breached. These alerts can be configured to notify the facilities team only when the temperature has stayed out of range for a specified period of time – preventing managers from receiving alerts every time a refrigerator door is opened.

If problems arise, a graphical display of the facility’s floor plan guides support teams to the trouble spots. And when the monitoring manager is not in the office or is moving around the campus, the system sends email or text-message alerts to mobile devices.

Implementing an automated system means all the time spent on a manual system is now allocated to patient care, where it should be. This means less money spent on staffing for manual checks and more money spent doing what hospitals do best: Care for patients in the best possible way.

Can You Guarantee The Safety of Your Vaccines?

A recent study by the Department of Health and Human Services Office of the Inspector General (HHS OIG) uncovered that providers generally did not meet vaccine management requirements nor maintain required documentation. As a result of the study, the Centers for Disease Control (CDC) has issued new recommendations for the storage and handling of temperature-sensitive vaccines.

When the HHS OIG report was released in June, 2012, ABC News published the story on the evening news, creating higher awareness of vaccine storage issues among the general public.

To help mitigate vaccine storage risks, the new Interim Guidance from the CDC focuses on five key recommendations:

  1. Use of biosafe glycol-encased probes or similar temperature-buffered probes to measure temperatures within refrigeration units rather than measurement of ambient air temperature.
  2. Use of digital data loggers with detachable probes that record and store temperature information at frequent programmable intervals for 24-hour temperature monitoring.
  3. Use of stand-alone refrigerator and stand-alone freezer units for vaccine storage rather than combination units.
  4. Discontinuing the use of dorm-style or bar-style refrigerator/freezers for ANY vaccine storage.
  5. Weekly review of vaccine expiration dates and rotation of vaccine stock.

Our own independent study confirms the need for automated temperature monitoring to protect valuable vaccines, pharmaceuticals and other temperature-sensitive medical supplies. More than 75 percent of the Facility, EC and Compliance Managers at hospitals and healthcare facilities polled feel that manual monitoring will cause a regulatory compliance issue in the next two years.

With so much at stake – and now new government guidelines in place – can you afford to take chances with the storage temperatures of your valuable vaccines?

For more detailed information about the new guidelines, download the official CDC documents, or visit the Vaccine Storage & Handling Guidance section of the CDC Website.

Facility Monitoring & Compliance Management Overview

Primex Wireless solutions automate, monitor, document and report essential activities performed by the facility management staff including compliance surveys, temperature monitoring, indoor air quality monitoring, emergency light testing and time synchronization. All solutions are delivered via a single software platform which allows facility teams to manage multiple functions without having to deploy, learn and maintain multiple systems. Primex sensors, clocks, emergency lights and other devices leverage 802.11 b/g wireless and Ethernet networks to communicate diagnostic data and receive updates. No additional infrastructure is necessary and a greater return on the investment into existing IT networks is achieved.

Reducing cost, improving facility staff efficiency and reducing risk are significant gains realized from Primex solutions. By automating repetitive and routine tasks to comply with regulatory requirements, Primex Wireless technology can ensure your facility is achieving ongoing compliance while reducing impact on facility staff.

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