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Clinical Infection & Immunity

Original Article

Volume 9, Number 1, March 2024, pages 1-10

The COVID-19 Pandemic and Its Impact on Patient Safety Incidents at a University Hospital: A Retrospective Study

In Japan, over 30 million cases of novel coronavirus disease 2019 (COVID-19) have been reported as of May 2023. The COVID-19 pandemic has disrupted many aspects of society [1]. Various problems such as the acceptance of COVID-19-positive patients at medical institutions and the use of information and communication technology in the medical field have been highlighted [2]. Fukuoka University (FU) Hospital in Fukuoka City is located on the island of Kyushu in Japan. The hospital has 915 beds, and approximately 2,000 medical staff members, mainly in 23 clinical departments, 15 clinical divisions, and 18 clinical support divisions. At FU Hospital, in addition to accepting and caring for patients with moderate to very severe COVID-19 infection, the situation inside the hospital has changed dramatically from before the pandemic, including the occurrence of clusters in FU hospital and the COVID-19 infection among medical staff. On the other hand, in the medical field, it is necessary to maintain patient safety and hospital functions as usual, even during a pandemic. The COVID-19 pandemic has significantly disrupted the delivery of healthcare services worldwide [3]. Due to various restrictions on hospital functions as a result of the pandemic, there is a risk of an increase in patient safety incidents [4].

The major reason for submitting patient safety incident reports at medical institutions is to prevent serious medical accidents [5]. When patient safety incidents and accidents occur in the hospital, the incident reports are submitted to general risk and safety managers from various occupations. To reduce the hospital-wide risk, prompt, correct, and fair incident reporting is mandatory [6]. It is important to reduce the number of critical incidents in patient care by improving the incident report system [7]. The Division of Medical Safety Management at FU Hospital was established in 2003. Its members include medical doctors, nurses, pharmacists, clinical technicians, radiologists, and administrative staff. Our hospital must always supply the safest medical care because it, as a local advanced medical center, provides a higher level of medical care. Therefore, the division has established a “culture of safety” in all members of the medical staff in the hospital through an action program. Since 2020, medical staff have been exposed to an increased workload and psychological stress due to the COVID-19 pandemic. However, even during a pandemic, it is necessary to prevent serious medical accidents, so it is important to submit incident reports, analyze contributing factors, and work to prevent recurrence. Although it has been reported that there is no fixed trend regarding the month in which incidents occur [8], since 2020, the pandemic has manifested as eight distinct waves of COVID-19 infection in Fukuoka City as well as in our hospital. To date, Fournier et al have provided the only report on the relationship between the COVID-19 pandemic and incident reports [9]. Constraints from the first wave of the COVID-19 pandemic have contributed to patient safety incidents in non-COVID-19 care [9]. Thus, it is still unclear how the COVID-19 pandemic affected patient safety in clinical settings. Therefore, we hypothesized that, due to the demands of the COVID-19 pandemic, medical staff have been extremely busy working in the hospital and have had less time to submit incident reports regarding the treatment of other patients, which would result in a decrease in the number of incident reports. Since Fournier’s report covered only the effect of the first wave of the pandemic on general practitioners [9], in the present study, we decided to examine in detail the impact of the COVID-19 pandemic over a 3-year period (from the first wave to the eighth wave) on safety incidents in Japan. We determined the association between the COVID-19 pandemic and safety incident reports at FU Hospital.

We conducted a retrospective study on patient safety incidents reported at FU Hospital in Fukuoka City, Japan, before and during the COVID-19 pandemic period. In Japan, the year starts in April, not January. Therefore, the year 2020 is from April 2020 to March 2021. Likewise, the year 2021 is from April 2021 to March 2022, and year 2022 is from April 2022 to March 2023, as shown in the tables and figures. The protocol in this study was approved by the Institutional Review Board of Fukuoka University and conducted in accordance with the Declaration of Helsinki. All data were collected from incident reports and medical records.

Data on the number of subjects with COVID-19 infection at FU Hospital were collected from the General Affairs section, FU Hospital. To analyze the number of subjects infected with COVID-19 in Fukuoka City, we used data from the “Outbreak Situation in Fukuoka City” on the Fukuoka City website.

A patient safety incident is defined as “an event or circumstance that could have resulted, or did result, in unnecessary harm to a patient” [10]. We considered patient safety incidents during the COVID-19 pandemic in hospitalized patients and outpatients receiving care.

The following variables were described: age and gender of patients who had an incident, number of incidents in each month, type of incident (instruction or communication, drug or blood transfusion, curative treatment, medical equipment, drains and tubes, examination, recuperation scene, meals and nutrition, abuse, violence and sexual harassment, fall and tumble, and others), type of staff who reported the incident (medical doctor, nurse, pharmacist, and others), incident severity and continuity classification. The incident severity and continuity classification (levels 0, 1, 2, 3a, 3b, 4a, 4b, 5 and unclassified) are widely used in Japanese hospitals to evaluate the impact of the incident on the patient and is based on a classification system developed by the National University Hospital Council of Japan [11, 12]. Table 1 shows the eight ranks in the system according to incident severity and continuity impact for patients.

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Table 1. Incident Severity Classification System Recommended by the National University Hospital Council of Japan

The total number of patient bed-days admissions and outpatients at the FU Hospital in each month were reported. The number of incidents per 10,000 patient bed-days plus outpatients in each month was also calculated.

The primary endpoint was the association between the number of incident reports in the FU Hospital and the number of inpatients with COVID-19 at the FU Hospital or in Fukuoka City. The secondary endpoints were the associations between the monthly changes in the number of incidents by occupation, gender, type of incident (contents), or levels described in the incident reports and the number of inpatients with COVID-19 infection at FU Hospital or the number of subjects with COVID-19 infection in Fukuoka City.

The data were downloaded into Microsoft Excel (Microsoft Corp., Redmond, WA, USA), manually cleaned, and analyzed using Microsoft Excel and StatView 5.0 (SAS Institute, USA). Continuous variables are shown as the mean ± standard deviation. Continuous variables were compared between the groups by an unpaired t-test. We used Pearson’s correlation coefficient to analyze the correlations of various factors by year and month. A P value of less than 0.05 was considered to reflect a significant difference.

Table 2 shows the number of patient safety incidents and incident contents and their levels before the pandemic (2017 - 2019) and during the pandemic (2020 - 2022). There was no significant difference in the total number of incidents between before and during the pandemic (P = 0.757). On the other hand, the total number of hospitalized patients plus outpatients during the pandemic was significantly lower than that before the pandemic (P = 0.001). No significant differences in the number of incidents classified by the incident reporter’s occupation, patient’s gender, or contents, except for meals and nutrition (P = 0.037), were observed between before and during the pandemic.

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Table 2. Total Number of Incidents and Hospitalized Patients Plus Outpatients, and the Number of Incidents Classified by the Incident Reporter’s Occupation, Patient’s Gender, Incident Contents and Incident Levels

Since there was a significant difference in the total number of hospitalized patients plus outpatients between before and during the pandemic, we calculated the number of patient safety incidents and other factors reported per 10,000 hospitalized patients plus outpatients (Table 3). The number of cases before and during the pandemic was 55.0 ± 3.6 and 61.6 ± 3.9 cases, respectively; the number during the pandemic tended to be higher than that before the pandemic (P = 0.095). Drug or blood transfusions were the most frequently reported incidents both before and during the pandemic, followed by fall and tumble, medical equipment, drains, and tubes. The number of instruction and communication incidents before the pandemic was significantly less than that during the pandemic after adjustment by the total number of hospitalized patients plus outpatients (P = 0.011). Regarding the incident level, level 1 was the most common, followed by level 2. In addition, there was a significant difference in the number of reports according to the incident reporter’s occupation, and the number of incident reports from medical doctors before the pandemic was significantly lower than that during the pandemic (P = 0.008). There was no difference in reports according to the patient's gender between before and during the pandemic.

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Table 3. Number of Incidents per 10,000 Hospitalized Patients Plus Outpatients, Classified by the Incident Reporter’s Occupation, Patient’s Gender, Incident Contents and Incident Levels

The number of patients with COVID-19 infection in each month in Fukuoka City or at the FU Hospital from 2020 to 2022 is shown in Figure 1a, b. The COVID-19 pandemic in Fukuoka City has had eight waves during the past 3 years. The number of patients hospitalized due to COVID-19 infection at the FU Hospital peaked slightly earlier than the number of patients with COVID-19 in Fukuoka City for the first wave through the seventh wave. For the eighth wave, the peaks occurred at the same time.

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Figure 1. (a) Number of subjects with COVID-19 infection by month in Fukuoka City from 2020 to 2022. (b) Number of subjects with COVID-19 infection by month at Fukuoka University (FU) Hospital from 2020 to 2022. (c) Number of incident reports at FU Hospital from 2020 to 2022. (d) Number of incidents per 10,000 hospitalized patients plus outpatients at FU Hospital from 2020 to 2022. The dotted lines indicate the peaks of the first to eighth peak waves of the COVID-19 pandemic in Fukuoka City. COVID-19: coronavirus disease 2019.

The number of incidents and the number of incidents per 10,000 hospitalized patients plus outpatients at the FU Hospital are shown in Figure 1c, d. If we consider the number of incidents per 10,000 hospitalized patients plus outpatients at the FU Hospital from the peak of the first wave to the peak of the eighth wave, there was almost an increase in COVID-19 infection. Shortly thereafter, the number of incidents per 10,000 hospitalized patients plus outpatients decreased from the peaks of the third to eighth waves.

We analyzed the correlation between the number of patients with COVID-19 infection in each month in Fukuoka city and the number of monthly incidents per 10,000 hospitalized patients plus outpatients at the FU University in 2020, 2021, and 2022 (Fig. 2a-c). In 2020, a significant negative correlation was observed between the number of COVID-19 cases and the number of incidents (r = -0.623, P = 0.031). However, this correlation was not significant in 2021 (r = -0.348, P = 0.267) or 2022 (r = -0.225, P = 0.483).

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Figure 2. Association between the number of patients with COVID-19 in each month in Fukuoka city and the number of incidents per 10,000 hospitalized patients plus outpatients in each month at the Fukuoka University (FU) in 2020 (a), 2021 (b) and 2022 (c). COVID-19: coronavirus disease 2019.

Figure 3 shows the incident contents by month per 10,000 hospitalized patients plus outpatients from February 2020 to March 2023. The monthly number of incidents involving drug or blood transfusion gradually decreased over the past 3 years. In particular, this value decreased during the second, third, sixth, and seventh waves of the COVID-19 pandemic. After the peak of each wave, the number of incidents before the wave did not recover before the next wave. The number of incidents with other contents did not seem to have changed much over the past 3 years.

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Figure 3. Number of incidents per 10,000 hospitalized patients plus outpatients by incident contents in each month from 2020 to 2022. The dotted lines indicate the peaks of the first to eighth waves of the COVID-19 pandemic in Fukuoka City. COVID-19: coronavirus disease 2019.

Figure 4 shows the incident levels per 10,000 hospitalized patients plus outpatients by month from Feb 2020 to March 2023. The monthly number of incidents of level 1 gradually decreased over the past 3 years. In particular, this number decreased significantly during the first, third, sixth, seventh, and eighth waves or just after waves of COVID-19 infection. After each wave peak, the number of incidents of level 1 did not recover to the number before each wave; and when the next wave occurred, the number of cases at level 2 showed a similar trend.

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Figure 4. Number of incidents per 10,000 hospitalized patients plus outpatients by incident levels in each month from 2020 to 2022. The dotted lines show the peaks of the first to eighth waves of the COVID-19 pandemic in Fukuoka City. COVID-19: coronavirus disease 2019.

In this study, we obtained three main results. First, the number of patient safety incidents reported per 10,000 patients during the pandemic tended to be higher than the pre-pandemic value. Even during the COVID-19 pandemic, the total number of incidents did not change, and the increasing trend was a desirable result. Second, at the time of the peak in a COVID-19 wave and just after the wave, the number of incidents reported decreased. Third, the number of incidents involving drug or blood transfusion and the number of monthly incidents of level 1 or 2 gradually decreased during the pandemic.

Incident reports are important tools for identifying the cause of incidents and implementing measures to prevent their recurrence [13]. There is a positive correlation between the number of incident reports and an improved safety culture within the organization [14]. The number of patient safety incidents reported per 10,000 patients during the pandemic tended to be higher than the pre-pandemic value. Efforts to increase the number of reported incidents include publishing the number of reported incidents, publishing investigation results and improvement measures, collecting information on level 0 events (near-miss incidents), and minimizing the number of items that must be included in a report. At our hospital, we have introduced a computer program that makes it easier for staff to view report information, create and upload reports. We also hold regular medical safety education seminars to encourage their participation and perform the examination. Even during the COVID-19 pandemic, these strategies are considered to contribute to the increase in the number of incident reports.

Although the overall number of incidents itself tended to increase between before and after the pandemic, there was a decrease in the number of incidents of levels 1 and 2. Heinrich’s law states that for every serious accident there are 29 minor accidents and 300 abnormalities (near-miss incidents) [15]. According to this law, a decrease in the number of low-level incidents, such as levels 1 and 2, is not necessarily good. There are several potential reasons for this decrease in the number of low-level incidents. Since medical staff were busy caring for patients with COVID-19 infection, it is possible that the number of incidents reported decreased merely because staff did not have enough time to report low-level incidents. Staff may not have felt the need to report these minor incidents in the midst of a worldwide pandemic. Since the number of incidents reported decreased from the third wave to the peak of the eighth wave at the FU Hospital, incidents related to items such as drug or blood transfusion decreased.

In this study, a significant negative correlation was observed between the number of COVID-19 cases in Fukuoka city and the number of incidents at the FU Hospital in 2020, but not in 2021 or 2022. Thus, in 2020, when the number of patients with COVID-19 infection increased, the number of incident reports decreased significantly, but this relationship faded from 2021 to 2022. This may be a sign that medical staff had become accustomed to treating COVID-19 patients and gradually regained enough time and attention to report incidents. During this time, various vaccines and medications against COVID-19 infections became available for clinical use [16, 17]. Although it did not have a large percentage of the population at the first period accepting the vaccine and willing to vaccinate in Japan, after that, vaccination rates have gradually increased.

The fact that COVID-19 itself has gradually weakened [18] may also have contributed to this change. However, as mentioned above, this was not the case during the peak of the COVID-19 wave. However, it did not have a large percentage of the population accepting the vaccine and willing to vaccinate.

While the effect of the COVID-19 pandemic on reported incidents is important, there was also a delay in the diagnosis of acute conditions other than COVID-19 [4]. In fact, patient fear of COVID-19 has been shown to increase delays in hospital treatment for myocardial infarction [19]. Considering that these problems should be resolved before those associated with incidents, we must prepare for the next pandemic.

This study has several limitations. This was a single-center, retrospective study. The background of the patients who were involved in the incident has not been analyzed in detail. It did not take into account the number of employees who tested positive for COVID-19 and took time off work. A more detailed investigation of incidents is necessary at a local and national level, supported by a systems theory-based framework.

The COVID-19 pandemic affected the contents and levels of incident reports. Overall, the number of incident reports tended to increase during the pandemic compared to that before the pandemic, probably because medical staff were well-informed during the pandemic. This study may provide an opportunity to further mitigate similar patient safety incidents during similar crises in the future. Sharing lessons from this crisis with others will strengthen future patient safety.

Acknowledgments

The authors received assistance and thanked all of the medical stuff at the FU Hospital for their help in data collection.

Financial Disclosure

The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.

Conflict of Interest

The authors report no conflict of interest. The authors alone are responsible for the content and writing of the paper.

Informed Consent

Patient consent was waived due to their opportunity to disclose and decline information to participate in the research.

Author Contributions

Conceptualization: RK, SI, and SM; methodology: RK, AO, and TS; data collection: RK, MN, TI, AO, and TS; formal analysis: RK and SM; investigation: RK, MN, TI, AO, and TS; writing-original draft preparation: RK; writing-review and editing: HW and SM; supervision: AI and SM. All of the authors have read and agreed to the published version of the manuscript.

Data Availability

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

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