Abstract
COVID-19 vaccines are in high demand and require specific handling and storage for effective distribution. Recent reports from hospitals and storage facilities have disclosed the loss of >2600 COVID-19 vaccine doses mostly due to malfunctioning ultralow temperature (ULT) freezers or insufficient facility support: (https://www.latimes.com/california/story/2021-01-04/freezer-broken-california-town-had-to-use-or-lose-vaccine-shots), Boston 25 News (https://www.boston25news.com/news/health/nearly-2000-doses-covid-vaccine-spoiled-jamaica-plain-va-facility-after-freezer-unplugged/TWYS7X2LSZACNFGADCE5XTAAOA). Another report from the Washington Post shows the emergency need for transfer of >1600 doses at odd hours due to ULT freezer failure (https://www.washingtonpost.com/health/2021/01/30/seattle-coronavirus-vaccine-overnight).
These reports emphasize the urgent need for reliable refrigeration of COVID-19 messenger RNA vaccines in ULTs. Proper storage and distribution of the COVID-19 vaccine at pharmacies, clinics, and hospitals may become complicated for a variety of reasons: limited access to ULT freezers, lack of appropriate accommodations to house freezers, limited expertise in handling samples in ULTs, and a lack of experience with vaccine storage and distribution. Maintaining an adequate cold chain is one of the most challenging aspects of the delivery of the vaccine. Furthermore, clinics and hospitals are not often equipped with ULT freezers nor are their staff trained to support work at cryogenic temperatures. To fill this gap in storage and distribution, we suggest the incorporation of College of American Pathologists (CAP)-accredited biorepositories (BRs) into COVID-19 vaccine rollout plans.
Many BRs have developed ULT storage capabilities featuring −80°C freezers, −150°C liquid nitrogen (LN2) vapor phase freezers, or −190°C LN2 liquid phase freezers. As per National Cancer Institute/International Society for Biological and Environmental Repositories/CAP guidelines, these facilities maintain ULT freezers under best practices for adequate space, emergency power supply, real-time remote monitoring with real-time notification systems, data storage, management of inventory and distribution, and expertise in shipping and handling of materials at cryogenic temperatures.
BRs are not considered clinical space and their equipment has generally not been registered with a medical device regulatory body (e.g., Food and Drug Administration), that is, they have not been evaluated for the storage of samples for diagnostic use or for samples to be reintroduced to the body. In 2019, the Centers for Medicare and Medicaid Services (CMS) approved a CAP BR checklist of requirements that aligns with the Biorepository Accreditation Program and the Clinical Laboratory Accreditation Program (CLIA). CMS grants CAP status to inspect BRs on behalf of the CLIA law.
Utilizing CAP-accredited BRs may help to significantly reduce loss of vaccine doses due to inadequate facilities, while maintaining adherence to optimal standard operating procedures (SOPs). Integrating existing CAP-accredited BRs into the COVID-19 vaccine rollout plan will help to minimize losses and improve vaccine storage and distribution.
Qualifications of CAP-accredited BRs are as follows:
Space: BRs have existing nonclinical space to host a number of Wi-Fi-enabled ULT freezers, with available emergency power supply, oxygen sensors, and other engineering controls. Some hospital-associated BRs provide the added benefit of proximity to associated pharmacies, clinics, and hospital for rapid distribution. ULT freezers: For biospecimen collection, CAP-accredited BRs operate freezers ranging from −80°C, −150°C LN2 vapor phase to −190°C freezers. ULT freezers are plugged into emergency power outlets, which are a part of the emergency electrical backup system. Real-time monitoring: Most ULT freezers at CAP-accredited BRs have monitoring through online systems for which a risk management plan is implemented. The online monitoring system allows for real-time 24/7 monitoring with 1-minute resolution. When the temperature rises above a preset critical value, all users at the BR automatically receive a notification through a phone messaging system and through e-mail. Data storage: Many BRs use Laboratory Information Management systems to organize and administer sample storage. The system provides the exact location of the samples in UTL freezers. This functionality could help track vaccine vials. Shipping and handling at cryogenic temperatures: All the personnel in CAP-accredited BRs follow International Air Transport Association guidelines and SOPs. BR staff members are trained to ship any materials that are subject to cold chain management with sufficient refrigerant to maintain its temperature throughout the shipping cycle. Training: All the personnel at BRs receive training and are deemed competent to handle storage in ULTs.