On Friday, Nov.13, the president of the United States said millions of doses of coronavirus vaccine will be available to front-line workers and the elderly, and 20 million people could be vaccinated in December.
As a health care facility manager, I have to ask:
Should hospitals and other health care organizations be preparing for COVID-19 vaccines?
The plain and simple answer is yes, each hospital and health care organization should be preparing for the COVID-19 vaccine(s) that will be approved for emergency use in the near future. Once approved, hospitals and health systems have a significant role to play throughout the vaccine distribution and administration process.
Health care providers will tell you how vaccines have eradicated smallpox, changed the global impact of chicken pox and polio, and minimized the impact of countless other diseases. But for a vaccine to work, people must be willing to receive it, and that requires trust. Unfortunately, there currently is potential for distrust around these critical tools of public health.
That’s why it is our responsibility to reassure our staff, patients and communities that any Food and Drug Administration-approved COVID-19 vaccine is safe, effective and only available after being subjected to a rigorous review process grounded in peer-reviewed, evidence-based science.
To build that trust, each hospital/health system should assemble a vaccine workgroup. The American Hospital Association recommends that the vaccine workgroup be comprised of representatives from multiple disciplines: physicians and advanced practice providers, pharmacy, legal, risk management, materials management, human resources, information technology and communications, logistics, facility management, security and employee health. The American Society for Health Care Engineering (ASHE) encourages its members to provide relevant input and expertise as the workgroup develops plans for storage and distribution of a vaccine. The workgroup should identify and inventory current vaccination programs and resources.
The vaccine workgroup should meet as often as needed but at least weekly in the beginning planning stages, with a clear expectation that this cadence might increase over the coming weeks and months. Topics for discussion (and potential subcommittees) should include, but not be limited to:
- State and federal coordination. The federal government required every state in the country to send a statewide vaccine distribution plan by Friday, Oct. 16. You can obtain your state’s plan via the Centers for Disease Control and Prevention’s webpage . If you notice a gap in your state’s plan or have not been engaged in the implementation of the plan, reach out to your state hospital association and the American Hospital Association immediately.
- Validating a vaccine’s readiness. While each vaccine will need to meet the Food and Drug Administration’s efficacy and safety requirements for approval, certain differences amongst the candidates will exist. You will need to establish your own standards for validating a vaccine’s readiness by identifying what elements must be present in order to endorse and verify a vaccine’s safety and effectiveness before its administration to patients and staff.
- Vaccination policy. Hospitals and health systems are required to have an influenza policy already in place. A SARS-CoV-2 vaccination policy also should be considered by each organization. How much the SARS-CoV-2 policy will mirror the organization’s influenza policy should be discussed.
According to the CDC’s Vaccine Storage and Distribution Tool Kit (November 2020), a health care organization should follow the proper storage and handling crucial to an effective vaccine cold chain. Per the CDC:
"A cold chain is a temperature-controlled supply chain that includes all vaccine-related equipment and procedures. The cold chain begins with the cold storage unit at the manufacturing plant, extends to the transport and delivery of the vaccine and correct storage at the provider facility, and ends with administration of the vaccine to the patient."
Key to the success of a robust cold chain is staff training, storage and handling standard operating procedures (SOPs). Recommendations and best practices for staff training and creating robust storage and handling SOPs can be found in the CDC Vaccine Storage and Distribution Tool Kit linked above.
One of the key issues for facilities managers is the importance of knowing the exact storage requirements for the vaccine being received. It has been reported that Moderna’s vaccine has to be shipped at -20 Celsius (-4 Fahrenheit), and can be stored at that temperature for six months. Once thawed it needs to be stored in a refrigerator between 2 and 8 C (36 and 46 F) and is good for up to 30 days. Pfizer’s vaccine has been reported that it must be transported and stored at -70 C (–94 F) and once thawed and transferred to a refrigerator, it must be administered within five days. Hospitals and health systems will need to provide the appropriate freezers and refrigerators to accommodate the storage and administration of the specific vaccines they receive.
Given the potential need to store vaccines in a cryogenic (or ultra-low temperature) environment, ASHE published “Selection and Preparation for Cryogenic Vaccine Storage,” which provides basic information to help discern which type of system will work best given their facility’s existing infrastructure.
There are two basic types of cryogenic storage (CS) available on the market today, compressor-driven refrigerant and liquid nitrogen (LN2) cooled. Each option has pros and cons that should be taken into account when planning a space for use.
Whichever system your team selects, there are several considerations that must be taken:
- Perform a multidisciplinary risk assessment.
- Evaluate the space and utilities needed.
- Evaluate life cycle costs.
- Develop or review safety procedures.
- Ensure mechanics and staff are trained on proper use and handling.
Any storage and distribution plan should also include information about the safe administration of the vaccine. Several precautions need to be considered in planning for the administration of the vaccine(s). You may need to identify and secure the use of appropriate alternate care sites (hotels, stadiums, schools) so that health systems are able to administer the vaccine(s) to large groups of people while still maintaining good social distancing. Setting up these sites will be a challenge but the information for alternate care sites within the organization’s influenza plan should be considered in establishing these sites.
The use of alternate care sites will also need to be staffed with security for the staff and vaccine and to discourage any issues with individuals who are not yet eligible for the vaccine but might show up to alternate care sites. Some of the security measures that should be considered are:
- Access to the property and facility including traffic control and patient flow.
- Need for buffer zones or security perimeters for crowd and/or traffic control.
- Delivery of the vaccine and storage within the facility.
- Procedures for staff, patient and visitor identification.
- Procedures for staff to report suspicious activities.
- Guidance on when to request assistance from local law enforcement.
- Communication procedures for local fire or emergency medical services response.
Hospital and health system leaders, including facility management professionals, will be critical to help engender public trust in a COVID-19 vaccine by promoting transparency, leading community-wide planning efforts, communicating clearly and regularly with internal and external stakeholders and, above all, remaining heavily invested in the health and safety of those in their care.