Using Failure Mode, Effect and Criticality Analysis to Improve Safety in the COVID Mass Vaccination Campaign.

Vaccination against SARS-CoV-2 will likely be the most promising way to combat the pandemic. Even if mass vaccination is urgent, it should still always be supported by appropriate patient safety management. The aim of this study, based on failure mode, effects and criticality analysis (FMECA), was to identify possible failures and highlight measures that can be adopted to prevent their occurrence. A team of resident doctors in public health from the University of Padua and specialists in risk analysis in public health examined the mass vaccination process. A diagram was drafted to illustrate the various phases of mass vaccination, analyze the process, and identify all failure modes. Criticalities were ascertained by rating the severity, frequency and likelihood of failure detection on a scale of 1 to 10. We identified a total of 71 possible faults distributed over the various phases of the process, and 34 of them were classified as carrying a high risk. For the potentially high-risk failure modes, we identified 63 recommended actions to contain the cause of their occurrence or improve their detection. For the purpose of detecting potential failures, FMECA can be successfully applied to mass vaccination, which should be considered a high-risk process.

Rebirth in a COVID hospital: a point of view.

BACKGROUND: Since COVID-19 was declared a pandemic, governments have taken actions to limit the transmission of the virus such as lockdown measures and reorganization of the local Health System. Quarantine measures have influenced pregnant women's daily lives. The aim of this study was to understand the impact of the changes imposed by COVID-19 emergency on the well-being of pregnant women and how the transformation of Schiavonia Hospital into a dedicated COVID hospital affected their pregnancy experience. METHODS: A cross-sectional survey was conducted. Pregnant women who gave birth in Schiavonia Hospital during the period May-September 2020 have been included. The assessment examined clinical characteristics, attitudes in relation to the pandemic and how it affected birth plans, perception of information received, and attitudes regards giving birth in a COVID hospital. RESULTS: One hundred four women responded to the survey, with an enrolment rate of 58%. About the influence of COVID-19 pandemic, 51% of respondents reported changing some aspect of their lifestyle. The identification of Schiavonia Hospital as COVID hospital did not modify the trust in the facility and in the obstetrics ward for the 90% of women, in fact for the 85.6% it was the planned Birth Center since the beginning of pregnancy. The communication was complete and exhaustive for 82.7% of the respondents. CONCLUSIONS: Despite the COVID hospital transformation, the women who came to give birth at Schiavonia Birth Center rated the healthcare assistance received at high level, evidencing high affection for the structure and the healthcare workers.

Schiavonia Hospital response to COVID-19 outbreak: a first single-center experience.

INTRODUCTION: On 21 February 2020, Schiavonia Hospital (SH) detected the first 2 cases of COVID-19 in Veneto Region. As a result of the underlying concomitant spread of infection, SH had to rearrange the clinical services in terms of structural changes to the building, management of spaces, human resources and supplies, in order to continue providing optimal care to the patients and staff safety. The aim of this article is to describe how SH was able to adjust its services coping with the epidemiological stages of the pandemic. MATERIAL AND METHODS: Three periods can be identified; in each one the most important organizational modifications are analyzed (hospital activities, logistical changes, communication, surveillance on HCW). RESULTS: The first period, after initial cases' identification, was characterized by the hospital isolation. In the second period the hospital reopened and it was divided into two completely separated areas, named COVID-19 and COVID-free, to prevent intra-hospital contamination. The last period was characterized by the re-organization of the facility as the largest COVID Hospital in Veneto, catching exclusively COVID-19 patients from the surrounding areas. CONCLUSIONS: SH changed its organization three times in less than two months. From the point of view of the Medical Direction of the Hospital the challenges had been many but it allowed to consolidate an organizational model which could answer to health needs during the emergency situation.