Background: Reports on unexpected donor events (UEs) during preparatory plasmapheresis (PPP) are scarce, and rarely consider technical UEs. Methods: Defined local and systemic UEs were graded by severity; technical UEs were not graded. On January 1, 2008, E.B.P.S.-Logistics (EBPS) installed the UE module for plasma management software (PMS). Donor room physicians entered UEs daily into the PMS. Medical directors reviewed entries quarterly. EBPS compiled data on donors, donations and UEs from January 1, 2008 to June 30, 2011. Results: 66,822 UEs were observed during 1,107,846 PPPs for a corrected incidence of 6.55% (1.4% local, 0.55% systemic, 4.6% technical UEs). 3.36% of PPPs were accompanied by 1 UE and 1.18% by >1 UE (2-5). 13.7% of donors undergoing PPP for the first time, 9.7% of those having a second PPP and 4.0% of those having a third or more PPPs were associated with UEs. Most common UEs were repeated venipuncture, and broken-off collection due to venous access problems and small hematomas. Severe systemic UEs occurred at a rate of 36 per 100,000 PPPs. Conclusions: Technical UEs were common with PPP. UEs accompanied first and second donations significantly more frequently than for subsequent donations.

B y November 2021, the coronavirus disease (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), had claimed >5 million lives worldwide, including >700,000 in the United States (1-3). Since its emergence in late 2019, SARS-CoV-2 has mutated, resulting in some variants categorized by the World Health Organization as variants of concern (VOCs). VOCs have evidence of potential increased infectiousness, immune evasion, and clinical severity, and they have spread globally. Some VOCs, such as Alpha and Delta, have become the predominant strain at different times and regions (4,5). COVID-19 diagnostics, therapeutics, or vaccines may have decreased effectiveness against VOCs (6,7). As of November 2021, VOCs in the United States included the Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and Delta (B.1.617.2) variants (3).Monitoring for VOCs is critical for management of the ongoing COVID-19 pandemic, enabling public health officials to track their public health impact, implement control measures, and allocate resources effectively. Detection of SARS-CoV-2 variants occurs primarily through genomic sequencing of isolates collected for PCR-based diagnosis of persons with active COVID-19 infection. Sequencing is resource-and time-intensive and has limits on capacity because of equipment, reagents, and trained personnel (8). As such, complete and timely sequencing of case isolates is not feasible or practical, particularly when case numbers have been high. During January 2020-September 2021, <3% of COVID-19 cases in the United States had isolates that were sequenced and available on public repositories (3). Nonrandom selection of isolates for sequencing and nonuniform result reporting could make results susceptible to bias and not truly representative of circulating variants (4,8,9). Also,

Monitoring SARS-CoV-2 variants of concern (VOCs) is critical for public health management of COVID-19. Case isolate sequencing is resource-intensive and not all isolates can be sequenced, and thus are not representative. However, since wastewater SARS-CoV-2 RNA concentrations correlate with COVID-19 case incidence in sewersheds, tracking VOCs through wastewater is appealing. We developed targeted digital RT-PCR assays to monitor abundance of select mutations in Alpha and Delta VOCs in wastewater settled solids, applied these to July 2020-August 2021 samples from two large metropolitan sewersheds, and compared results to estimates of variant abundance from case isolate sequencing. Wastewater measurements tracked closely with case isolate estimates at each site (rp= 0.82, 0.88 for Alpha and rp= 0.97 for Delta). Mutations were detected in wastewater measurements even at levels <5% of circulating virus and in samples available weeks before case isolate results. Therefore, wastewater variant monitoring should be strategically deployed to complement case isolate sequencing.

Background: Reports on unexpected events (UEs) during blood donation (BD) inadequately consider the role of technical UEs. Methods: Defined local andsystemic UEs were graded by severity; technical UEs were not graded. On January 1, 2008, E.B.P.S.-Logistics (EBPS) installed the UE module for plasma management software (PMS). Donor room physicians entered UEs daily into PMS. Medical directors reviewed entries quarterly. EBPS compiled data on donors, donations, and UEs from January 1, 2008 to June 30, 2011. Results: 6,605 UEs were observed during 166,650 BDs from 57,622 donors for a corrected incidence of 4.30% (0.66% local, 1.59% systemic, 2.04% technical UEs). 2.96% of BDs were accompanied by one UE and 0.45% by >1 UE (2-4). 6.3% of donors donating blood for their first time, 3.5% of those giving blood for their second time, and 1.9% of donors giving their third or more BD experienced UEs. Most common UEs were: discontinued collections due to venous access problems, repeated venipuncture, and small hematomas. Severe circulatory UEs occurred at a rate of 16 per 100,000 BDs. Conclusions: Technical UEs were common during BD. UEs accompanied first and second donations significantly more often than subsequent donations.

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