ABSTRACT
Background-aim: Our laboratory is accredited for point-of-care (POC) blood gases activities according to the ISO 22870 standard. When, in March 2020, the Covid-19 crisis hit France, risk assessment was done to adapt POC management to the setting up of 3 new dedicated Covid-19 intensive care units. Methods: We used our change management procedure based on risk assessment management (CLSI EP-23) and prioritization of risks (criticality scale) to reveal new risks to take into account: Material: - Insufficient number of blood gases devices. - Shortage of reagents requiring anticipating the potential peak of analysis (units full of ventilated patients). Manpower: - Newly trained-empowered people recruited for the Covid-19 crisis requiring to derogate from the usual training procedure to increase the rate of operational users. - Staffing shortage in the clinical units or in the laboratory due to illness. Methods: - Reduced initial analyzer performance check for quick commissioning. - Necessity of indicators to monitor the impact of derogations to usual procedures and to verify the adequacy with the clinicians needs. Environment: - Potential impact of SARS-CoV-2 on analyzers management (device contamination, waste, protection of users). Results: Material: One GEM 4000 was put back into service and 2 additional GEM 5000 (Werfen) were ordered and put into service the day of reception 9 days later. Reagent orders were tripled to avoid shortage due to potential future manufacturer’s deficiency. Eventually, POC blood gases activity increased +300% at the peak of the crisis in April without any particular problem. Manpower: 35 new users were trained-empowered with a quick-training procedure. A punctual lack of trained user never happened and daily monitoring of rejected analysis (new indicator) showed even better results than expected. Methods: Indicators allowed to verify that specific requirements of ISO 22870 were still achieved. Environment: No special procedure was required for the analyzer itself aside the general procedure for COVID-19 clinical unit management. Conclusions: Our change management procedure allowed our ISO 22870 accredited laboratory to add these new locations/POC analyzers to our scope of accreditation during the peak of the COVID-19 crisis.
ABSTRACT
Background-aim: SARS coronavirus 2 (SARS-CoV-2) is responsible for high morbidity and mortality worldwide, mostly due to the exacerbated inflammatory response observed in critically ill patients. However, little is known about the kinetics of the systemic immune response and its association with survival in Covid-19 patients admitted in ICU Methods: We performed a retrospective multicenter study including all patients with SARS-Cov-2 infection admitted in 3 ICUs between March 1st and April 15th 2020, with at least 2 measurements of Interleukin 6 (IL6) in 4 days (baseline and day 3-4). Patients who received immunomodulatory treatment were excluded. IL6 was measured on serum by ELISA (Quantikine R&D Systems) and results were expressed at median [25th – 75th percentile]. The relationship between IL6 and CRP, organ failure severity (SOFA score) or in-ICU mortality was analyzed. Results: From the 140 patients admitted in the 3 ICU for SARS-Cov2 infection (PCR diagnosis), 101 patients were included, the mean age was 59 ± 11 years with a high proportion of men (82%). Patients had severe respiratory disease with media SOFA score of 4 [3-7] and 83 required endotracheal intubation/mechanical ventilation at baseline. An increase of SOFA score between baseline and day3-4 was observed in 32 patients (worsening group). Baseline measurements were done 14 days [11-20] after onset of symptoms. At the end of the study, on April 15th 2020, 47 patients had been discharged from ICU, 35 were still in ICU, and 19 had died in ICU. Baseline IL6 concentrations were positively associated with SOFA score. Moreover, baseline IL-6 and CRP concentrations were significantly higher in the worsening group vs the non-worsening: 278 [70-622] vs 71 [29-153] pg/mL (P<0.01) for IL6 and 178 [100-295] vs 100 [37-213] mg/L (P<0.05) for CRP. However, IL6 concentrations were not correlated with CRP. Il6 and CRP concentrations were higher in non-survivors at baseline and at day 3-4. CRP significantly decreased in survivors (190 [80-248] to 108 [45-185], P<0.05) whereas IL6 decreased in both groups. Conclusions: In this multicenter cohort of ICU patients with SARS-CoV-2 infection, we found that Il6 was associated with organ failure severity, worsening and poor outcome.