Abstract

Background: To investigate any associations between new clinical policies implemented because of the COVID-19 pandemic and harm to patients. Methods: Retrospective data collection of incidents and complaints reported through Datix®, and the Patient Advice and Liaison Service (PALS), respectively. The setting was the Family Health division in a University teaching hospital in the UK. Primary and secondary outcome measures included: the proportion of incidents reported on Datix® from 23 March 2020 to 29 May 2020, compared to the period from 23 March 2019 to 29 May 2019. COVID-19 related incidents and complaints and association with newly published guidelines or pathways from 23 March 2020 to 29 May 2020 were investigated. Results: There was no significant difference in the proportion of overall patient activity resulting in incidents reported on Datix in 2020 (2.08%) compared to 2019 (2.09%), with 98% resulting in no/low harm in 2020. Three incident categories had increases in relative proportions of incidents including the terms “COVID” or “Corona” compared to incidents that did not: “Child death”, “delay/failure to treatment and procedure” and “information governance”. One of the child deaths was a miscarriage and we were unable to link the second child death to a change in clinical policy at this stage. We were only able to link two COVID-19 associated incidents with a pathway or procedural change (one to the Children’s Emergency Department admission pathway and the second to the introduction of virtual antenatal clinics). Eighteen complaints related to COVID-19 were logged. However, at this stage, we are unable to link any of these to a published change in clinical policy. Conclusions: New policies introduced in the division, during the COVID-19 pandemic were associated with similar rates of clinical incidents, when compared with the previous year. There were only two COVID-19-related incidents clearly related to a change in pathways and procedures. Continued surveillance and improved metrics for monitoring the impact of changes to pathways and procedures should be sought with the sustained presence of COVID-19 in clinical areas.

Highlights

  • The Parliamentary and Health Service Ombudsman paused their work on existing National Health Service (NHS) complaints and acceptance of new health complaints from 26 March 2020 to 30 June 2020, and this study provided an opportunity to find out if this had an impact on incident reporting rates in our hospital during the COVID-19 pandemic [7]

  • The focus on the Family Health (FH) division which covers Obstetrics, Gynaecology, Paediatrics (Children’s Hospital), Clinical Genetics and Sexual Health was because two of the authors were in the senior management team of the division and felt it was very important to inform their decision making on objective data on patient safety

  • Our study found a reduction in the numbers of incidents reported, when corrected for the of overall patient activity, the proportions of incidents reported before and after the COVID-19 lockdown were not statistically significant

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Summary

Introduction

The Coronavirus disease 2019 (COVID-19) [1] pandemic resulted in an unprecedented change in global health care delivery. As of 2 March 2021, 115,198,775 cases had been reported globally with 2,554,564 deaths. The corresponding figures in the UK, were, 4,188,400 cases and 123,296 deaths [2]. In response to the pandemic, in a televised address, the British prime minister, The Rt Hon., Boris Johnson MP, announced a UK-wide partial lockdown, to contain the spread of the virus. The British public were instructed that they must stay at home, except for certain “very limited purposes”—shopping for basic

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