Background: Patient safety indicators (PSI) are hospital quality measures designed by the Agency for Healthcare Research and Quality (AHRQ) to capture potentially-preventable adverse events. PSI-12 is defined as perioperative pulmonary embolism (PE) or deep vein thrombosis (DVT). It is unclear how active COVID-19 infection, which is known to be associated with coagulopathy, has impacted PSI-12 performance. Therefore, we sought to compare the cumulative incidence of PSI-12 in patients hospitalized with acute COVID-19 infection compared to those without acute COVID-19 infection.

Methods: This was a retrospective cohort including all PSI-12-eligible encounters at three Mayo Clinic medical centers in Minnesota, Arizona, and Florida from April 1, 2020 through October 4, 2021. Any patients with a COVID-19 diagnosis code or a positive COVID-19 polymerase chain reaction/antigen test during the hospitalization were considered to have acute COVID-19 infection. We compared the unadjusted rate of PSI-12 events among patients with COVID-19 infection versus patients without COVID-19 infection using Fisher’s exact chi-squared test, and we compared adjusted rates of PSI-12 by adjusting for the AHRQ/WinQI expected risk of PSI-12. We analyzed medical records of all COVID-19 infected patients who experienced a PSI-12 and summarized results of that case-series using frequencies, means, and qualitative methods.

Results: Our cohort included 50,400 consecutive encounters, of which 257 (0.5%) had acute COVID-19 infection (Table 1). Rates of PSI-12 events were significantly higher among patients with acute COVID-19 infection: 8/257 (3.11%; 95% CI [1.35%, 6.04%]) patients with acute COVID-19 infection vs. 210/50,143 (0.42%; 95% CI [0.36%, 0.48%]) uninfected patients experienced a PSI-12 event during the encounter (p<.0001). The risk-adjusted rate of PSI-12 was significantly higher in patients with acute COVID-19 infection (1.50% vs. 0.38%, p<.0001). The case series analysis of the eight VTEs in COVID-19 patients identified that all had severe disease requiring ICU care, and four of eight died in the hospital (Table 2). The most common procedure was tracheostomy (75%); the mean (SD) days from surgical procedure to VTE were 0.12 (7.32) days.

Conclusions: Acute COVID-19 infection is associated with a three-fold increase in the risk for PSI-12, and this increase is not accounted for with current risk-adjustment. However, acute COVID-19 infection is associated with hypercoagulability and critical illness, leading to unavoidable venous thromboembolism. Further, the VTEs in these patients often preceded the index surgical procedure. The present definition of PSI-12 is likely to negatively and differentially impact hospitals’ publicly reported quality performance. We recommend consideration of excluding acute COVID-19 from the PSI-12 denominator, or improving risk-adjustment for COVID-19, to avoid unintended consequences for tertiary and academic hospitals caring for the largest numbers of the sickest patients.

IMAGE 1: Table 1 – Demographic characteristics by acute COVID-19 status

IMAGE 2: Table 2 – Characteristics of acute COVID-19 infected patients with PSI-12 events