191 Something we must be proud of: team improvisation Table 5.2 Examples of challenges and improvised solutions (Continued) Step in donation process Examples of challenges Improvised solutions Testing of antibody levels – Testing method was not decided until July 2020 leading to a backlog of thousands of donations that needed to be tested. – Aliquots were obtained during donations and frozen. – Sanquin created an internal, sensitive total antibody bridging assays for detection of SARS-CoV-2 antibodies to the receptor-binding domain and nucleocapsid protein in addition to conventional isotypespecific assays.19 Quality assurance/ regulatory issues – System too slow; change control procedure too slow. – “Bend the rules without breaking them.” – Find ways to move around the system and have shortcuts in the system while ensuring quality and safety are maintained. – Details in processes changed through verbal agreement, and documented later (e.g., SOPs were revised continually and approved formally later). Abbreviations: CCP, convalescent plasma project; PCR, polymerase chain reaction; SOPs, standard operating procedures.
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