CONGRESS 2023 - Introduction of New D-dimer Assay in Response to the COVID-19 Pandemic (HSD Case Study)

Coagulopathy has been shown to play an important role in COVID 19 infection. Reported abnormal coagulation laboratory values in severe COVID-19 are most notably a 3-to-4-fold increase in D-Dimer (Yao et al., 2020). Several studies showed that elevated D-dimer in COVID-19 patients is associated with higher mortality. A retrospective cohort study carried out by Zhou, et al. (2020) also associated D-Dimer > 1000ng/ml with higher odds of in-patient death. At the onset of the COVID 19 pandemic, there was no consensus as to how D-Dimer levels should be used for the management of COVID-19 patients. In April 2020, PAHT decided to use a D-Dimer cut-off of 1000 ng/ml to determine anticoagulation dosage. The source of reference used by PAHT in their decision making employed a D-Dimer assay with a cut off value of 500 ng/ml for the exclusion of venous thromboembolism (VTE). This raised an issue as the source of reference used by PAHT at the time employed a D Dimer assay with a cut-off value of 230 ng/ml for the exclusion of VTE. This meant the trust was unable to implement the new COVID 19 care bundle at the time. The haematology laboratory wanting to do whatever possible to assist patient care agreed to change the current D-Dimer methodology immediately to support the trust COVID 19 care bundle. The verification and implementation of the new D-Dimer assay with cut of 500 ng/ml for the exclusion of VTE was completed within four weeks. A risk assessment and a change control were put in place to ensure users were made aware of the change in cut-off limit. This verification and implementation of the new assay was possible through the hard and collaborative work of the haematology technical team with shared vision, motivation coupled with team engagement and strong leadership.

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