TABLE 1.

Considerations to improve preparedness for future epidemic serosurveillance using large‐scale blood donor serosurveys

Challenges encountered in large‐scale serosurvey	Considerations to improve preparedness for future epidemic serosurveillance
No existing national BCO network committed to providing donor data and procuring residual blood specimens to serve epidemic testing needs	Identify and maintain a national network of BCOs to be prepared to provide donor data and residual blood donation specimens ready to contribute residual specimens when needed. An existing network could quickly determine infection seroprevalence levels regionally and temporally when outbreaks warranting donor serosurveillance occur. Identify appropriate groups to govern the national network, including a national coordinating entity (NCE). NCE to include representatives from the relevant government agencies and the blood collection industry as well as others with complementary expertise. Continuous funding to support the operations of the NCE and additional activities as summarized below.
No existing administrative framework for acquisition and testing of residual blood donor specimens	Establish national guidelines that would enable testing of de‐identified residual blood specimen results for new pathogens. Anticipate appropriate human subjects research requirements, where necessary. Maintain and enhance capacity to establish agreements between individual BCOs, donor testing labs, and the NCE or its delegate to function in response to prioritized outbreaks, including roles and responsibilities for BCOs, testing labs and the NCE. Maintain payment systems for entire program, including specimen acquisition, infectious disease testing for blood safety, testing for relevant serological markers, shipment of specimens to specialized testing laboratories, preparation of data files, and analyses.
BCOs and testing labs have varying levels of expertise and capacity to support relevant laboratory and data science needs	Each BCO and testing lab to define how it can quickly expand laboratory‐trained personnel at the start of a newly identified regional or national outbreak. Each BCO and testing lab to maintain minimum data processing capabilities needed to support rapid implementation and appropriate response consistent with evolving public health needs. Each BCO to develop and maintain operational preparedness, including SOPs and relevant training of BCO staff. Designate and train laboratory personnel located within the testing laboratories of each contributing BCO who, in times of national emergency, could be temporarily re‐assigned to support a dramatically increased volume of specimen acquisition and testing of residual blood donor specimens.
No guidelines for generating population estimates from BCO catchment areas	Establish and maintain population characteristics through regular submission (at least annually) of donation population information for each BCO in the national network. NCE to aggregate statistics on blood donations by zip codes of origin and demographic characteristics of donors. NCE to determine, on a frequent basis, how to pool donations from participating BCOs to generate testing results at the state level and by demographic subgroups. NCE to communicate a list of zip codes in sampling scheme to each BCO. Each BCO to develop and maintain up‐to‐date sampling algorithms and procedures.
No guidelines for timely communication of testing results to appropriate public health authorities	NCE to develop procedures for communication of study data to state and local health authorities. NCE to develop and maintain technology to effectively communicate results. NCE to establish protocols and procedures for communication of preliminary screening data to support real‐time feedback on community spread of novel infectious disease posing substantial risk to the larger population.
Flexibility needed in regulatory framework	Regulatory standards in the blood collection industry should anticipate the need to change processes more quickly in response to an emerging epidemic. For example, BCOs should be able to change their donor intake forms and processes to collect vaccination history or other donor information as needed in the context of a national emergency. NCE to work with regulators and blood collection industry to adopt guidelines granting authority to swiftly adjust procedures during public health emergencies.
Limited ability of cross‐sectional approach to track evolution of immunologic responses over time within individual donors	Establish “immunological observatory” of repeat donor cohorts with longitudinal specimens to compliment cross sectional serosurveillance. Serial serological data from repeat donations from donors with various categories of previous infection/vaccination provides the opportunity to identify and track incident infections and characterize Ab waning, vaccine breakthrough infections, and boosting following reinfections.