As of late January 2021, we’re in the early stages of the COVID-19 vaccine rollout. There are two vaccines approved for public distribution in the US, both of which are mRNA based (made by Moderna and Pfizer), with several others in late stage trials or approved for limited use. Roughly 38 million doses have been shipped, but only about half of them have been administered, because of various logistical limitations, including problems with temperature control in vaccine shipments.
We’re still a long way from the finish line. ‘Herd immunity’ for COVID-19, the condition where enough people have immunity to prevent the spread of a disease, is estimated to require inoculating between 50 to 80% of the population. Today, the machinery of production and distribution continues to scale up, with a combined 12-18 million doses shipping each week, theoretically enough to immunize about 100 million people by the end of March 2021 (see this tracker from the Washington Post for current figures).
In this article, we’ll cover some of the lessons learned so far in the vaccine rollout based on what Dickson has seen, with a particular focus on environmental monitoring. Many of these lessons simply reinforce the importance of rigorously following the known best practices related to vaccine handling and environmental monitoring in a cold chain. However, the scale of the current global pandemic has greatly magnified these issues, so this is a good opportunity to become refreshed on these practices.
1. Planning Ahead Is More Important Than Ever
Most of us know or have read news reports about people who have been given one of the initial vaccine doses. The diversity in patient experiences is a reflection of the unprecedented challenges in terms of personnel, resource allocation, and other logistical issues like scheduling. It also highlights the importance of proactive organization and planning to make sure the vaccines are utilized to their full potential.
Many vaccine doses so far have been administered at central locations. As we move forward, it is expected that more vaccinations will take place at smaller sites, like pharmacies and doctor’s offices. A more distributed approach is needed for higher throughput as larger segments of the population become eligible for the vaccine, but this approach will also require a different type of resource allocation and planning. To illustrate this, let’s consider a large hospital system with many patient sites. Some of the items that should be addressed proactively are:
- Which of the patient sites should be used for administering vaccines?
- How many freezer units, and which type, are required at each site? Note that the two vaccines currently approved by the FDA have significantly different storage temperature requirements. We’ll talk about that in more detail later in this article.
- What temperature monitoring scheme should be used for storage and administration sites? A monitoring scheme that can scale and adapt to unexpected situations is an integral part of an overall strategy to prevent temperature excursions and vaccine loss.
- What level and type of staffing is required, and what training is needed? It has been reported that the most scarce resource in terms of staffing is the vaccinators themselves. Therefore, staff should be allocated so that the vaccinators are never idle.
To date, planning has been made especially difficult by uncertainty in the number of doses that will be shipped to individual locations, and to some degree uncertainty in whether scheduled appointments will be kept by patients. There is very little that those involved in vaccine distribution and administration can do about this. Instead, we have to build and maintain systems that are able to adapt to a high level of uncertainty.
2. Organizations That Empower a Single Decision Maker to Run Their Vaccine Operation Fare Better
There are many different styles of decision making that organizations can use. At Dickson, we’ve observed that organizations where a single person is responsible for big-picture decision making for COVID-19 vaccine programs tend to have the best outcomes. Of course, these decisions can be made after consulting experts and stakeholders, but in these organizations, ultimate accountability for the vaccine operation rests with one individual.
This works well because it eliminates confusion about accountability, speeds up the process of decision making and delegation, and ensures that there is clarity about who is responsible for critical tasks.
In healthy organizations, this style of individual leadership filters through the hierarchy, so that people involved in day to day tasks like allocating resources, scheduling, responding to excursions, and so on, are given clear direction from a single source. It also empowers employees at all levels to make decisions based on data and their own best judgment.
This usually requires a change to the way leadership decisions are made in healthcare and technology-driven organizations, where it is generally accepted that a more decentralized approach to decision-making leads to more innovation. However, this has to be weighed against the need for fast, error-free execution of vaccine rollouts.
A key to effective decision making in this type of system is access to reliable, timely data. In the context of environmental monitoring, this takes the form of a cloud-based monitoring system like DicksonOne, where data from across a wide network of sensors can be accessed remotely, in real time.
3. Make SOPs for an Excursion Clear, Decisive, and Familiar
The mRNA based vaccines currently approved in the US are relatively sensitive compared to existing vaccines, and therefore have a narrow storage temperature window. The Pfizer vaccine must be stored between -80 and -60 °C, the Moderna vaccine between -25 and -15 °C, or refrigerated (with a 30 day shelf life) between 2 to 8 °C. Most common vaccines are stored at either -15 to -50 °C or 2 to 8 °C.
The CDC has a recommended procedure when a vaccine experiences a temperature variation outside of this range, known as a temperature “excursion”:
- Notify the vaccine coordinator, and quarantine any vaccine that may have been affected
- Fully document the details of the excursion (this is where a full temperature record of the event is extremely important)
- Contact the vaccine manufacturer for guidance on how to handle the affected material
- Correct the underlying root cause of the excursion
These steps are a good framework for a more detailed and specific plan for your organization. One key aspect of the SOP should be to maintain a well-documented, precise, and accurate temperature record if an excursion does take place. This record can then be provided to the vaccine manufacturer, who will work with your organization to make a decision about the disposition of the affected material.
Having a clearly written, action-oriented excursion SOP is not enough by itself. The SOP needs to be combined with effective training of the staff responsible for responding to excursions. Training should be conducted as part of new employee orientation, as an annual refresher, or when new vaccines or procedures are introduced. When possible, run through possible excursion scenarios so that the process of following the SOP steps becomes familiar.
In addition to having a clear, thorough response SOP and training program, carefully customized alarms can also mitigate or even prevent some excursions. With a modern remote monitoring system, custom alerts can be sent to specific personnel using various methods (SMS, phone call, or email). For example, when a freezer malfunction is detected, local maintenance personnel can be alerted directly. The alert can be set up to contain specific information about the situation, so that responding personnel are prepared when they arrive.
In some situations, alarms can be set up so that problems are detected and resolved before an excursion takes place. This can be done through a risk analysis, using historical data to help predict which parts of the system are most likely to fail.
Custom alarms can also be used to avoid “alarm fatigue”, a situation where excessive false alarms cause staff to ignore or disable them. This can be avoided by optimizing alarm triggers to reduce the number of false or nuisance alarms.
4. Now Is Not the Time to Be Lax With Keeping Calibrations Up-to-Date
Properly calibrated sensors are absolutely essential when monitoring sensitive vaccines. Sensors should be calibrated before installation, then at regular intervals during service. The most common types of temperature sensors, thermocouples and thermistors, work by measuring electrical properties of a material that vary with temperature. Any change to the material properties or damage to the active components can lead to drift in the reported temperature.
Recall that the storage temperature windows for COVID vaccines are relatively narrow, which emphasizes the need to keep up with regular sensor calibrations.
Temperature sensors going out of calibration is potentially even more dangerous than a refrigeration equipment malfunction, since a drifting temperature sensor is more difficult to detect. The consequences of this type of issue can be severe. Vaccines that are inadvertently administered after undergoing an excursion may require re-administration. In the worst case, if the excursion is not detected, anyone given the vaccine could incorrectly believe they have been immunized.
5. Detailed, Organized Record Keeping Is an Absolute Must
Maintaining complete, accurate environmental monitoring data is important across the entire cold chain, from manufacturing to vaccine administration, for a number of reasons:
- This temperature record is the only way to prove to patients, healthcare professionals, and auditors that the vaccine did not experience temperature excursions.
- If an excursion takes place, monitoring data be used to identify and intercept damaged vaccine batches before they reach patients.
- Monitoring data can be used to proactively troubleshoot equipment or training issues.
In a critical application like vaccine temperature monitoring, the FDA uses the ALCOA rule for data collection (Attributable, Legible, Contemporaneous, Original, and Accurate).
For monitoring COVID-19 vaccines specifically, the CDC recommends using a digital data logger (DDL) with a detachable probe placed in a temperature buffer. Every day, the high and low temperature points, or a complete record of the DDL data, should be checked to confirm an excursion has not taken place. The DDL data should then be stored for at least 3 years. The automation provided by a cloud based remote monitoring tool greatly simplifies these tasks.
These data collection practices are consistent with the customary CDC recommendations, and should be followed for any vaccine. However, the scale of the current rollout efforts are a reminder of their importance.
6. Find Out What Potential Vendors Have Done to Help Other Clients
Organizations that are responsible for the distribution and administration of vaccines are facing unprecedented challenges related to the scale-up required to meet vaccine demands (>10 million total doses per week) and to eventually achieve herd immunity (160-260 million immunizations total in the US). For health care providers, these challenges are combined with COVID-19 testing, contact tracing, and caring for patients with COVID-19 (not to mention other non-COVID-19 related issues).
For that reason, when evaluating potential vendors, organizations should consider: (1) how can the solutions the vendor offers simplify the tasks involved with vaccine delivery, and (2) what assistance does the potential vendor/partner provide to your organization, through consulting, evaluating your needs, training, and equipment onboarding? Do they provide clear, concise guidelines for using their equipment?
Take Dickson’s services team, which helps to implement scalable alerting templates. This added service means that when new locations are being onboarded, it only takes a few clicks for the new location to go live with the defined organizational procedures. For another example, Dickson provides freezer magnets so that key information is close at hand.
We’re at a critical point in the process of rolling out COVID-19 vaccines. A successful program will require massive scale-up and adaptability, while maintaining the same attention to detail that has been used for vaccine handling in the past.
We’ve observed that organizations that have done well up to this point focus on planning and training, and are deliberate about assigning accountability and decision making responsibilities to an individual. They also are proactive about their data collection and temperature monitoring equipment, and carefully select the vendors and partners they work with.