What do we know about this problem?

Central Line Associated Bloodstream Infections (CLABSI) are preventable and potentially fatal events, usual in the context of critical care patients. By mid-2018 an increase was noted in the incidence rate of CLABSI at a high complexity institution in Colombia, demanding immediate interventions to lower those numbers.

What does this study contribute with?

This study showed the effectiveness of the CQI method in achieving a significant reduction in CLABSI in the institution, its sustainability and changes in the healthcare processes, which suggests changes in the patient safety culture among all the teams involved. These lessons learned and improvement cycles may be used by other institutions and applied in other contexts. The results show that the continuous quality improvement cycle facilitated the identification of areas susceptible to errors in catheter insertion and maintenance in the institution. Moreover, it allowed for prioritizing the areas in need of intervention, and the teambuilding to design the interventions to be implemented in consecutive test cycles.

INTRODUCTION

Central Line Associated Bloodstream Infections (CLABSI) are defined as a laboratory confirmed bloodstream infection, not associated with an infection at a different site, which develops within 48 hours following the insertion of a central line. These events are mostly preventable and potentially lethal, usually occurring in the critical patient setting. (¹)

The incidence reported worldwide is variable, averaging 4.1 per 1,000 days-catheter, in accordance to the surveillance data of the International Nosocomial Infections Control Consortium (INICC) from January 2010 to December 2015 and a result of the analysis of 703 intensive care units in 50 countries. (²) In Colombia, the incidence reported has also changed over time; in 2018 a minimum was reached of 2.5 per 1,000 days-catheter which gradually increased up to 3.6 per 1,000 days-catheter in 2020, in accordance with the data from the National Surveillance System -SIVIGILA.(³)

It is estimated that CLABSI is one of the most expensive healthcare-associated infections for health services. In the United States it represented an increase in care costs of at least 23,751 dollars in 2011. (⁴,⁵) The care of this condition, with proper adherence to the infection control guidelines, could save between 5,520 and 20,239 lives per year. (⁴) In Colombia, this is the most frequent device-associated infection, with higher incidences than ventilator-associated pneumonia and catheter-related urinary tract infections. (³)

In July 2018 an increase in the incidence rate (IR) of CLABSI was reported at a high complexity institution in Colombia, amounting to 12.7 cases per 1,000 days-catheter and an average incidence rate for the first quarter of 2018 of 7.5 cases per 1,000 days-catheter, which exceeded the national average for the same period by about 5 cases per 1,000 days-catheter; this situation demanded immediate interventions to be able to reduce those numbers.

One of the proposed strategies was the use of a widely studied methodology known as Continuous Quality Improvement (CQI); a risk management intervention that promotes the sustained reduction in the incidence of infections in the institution. The continuous quality improvement methods have proven to be useful for the implementation of interventions in hospitals in developing countries. (⁶-⁹) For instance, a multinational collaborative project recently developed in Latin America, managed to reduce the incidence rate in 83 intensive care units by 22 % in average. (⁶)

Based on the available evidence on CQI as an effective intervention and the institutional need to significantly reduce the IR of CLABSI and ensuring the sustainability of such improvement over time, this project was suggested with a view to assess the effectiveness of the continuous quality improvement method to reduce the incidence rate of CLABSI at a university hospital in Bogotá, during 2018 and 2019.

METHODS

Intervention

CQI is a progressive incremental improvement of processes, safety and patient care. The objective of CQI may include improving operations, results, system processes, work environment or regulatory compliance. Process improvement may be "gradual" or "innovative"- The development of CQI projects usually includes the definition of the problem, a comparative assessment, goal setting, and then iterative quality improvement cycles. Through the iterative process, improvements are made, the effect of the improvements is measured and then the process is repeated until the desired result is achieved. (¹⁰,¹¹)

To intervene the hospital, the improvement team was made up by ten people who were part of the hospital clinical team: the medical director of the intensive care unit, the ICU head nurse, a professional nurse member of the institutional infections committee, a professional nurse head of the Patient Safety Directorship, a medical director of the Quality Office, a bacteriologist and three epidemiologists from the Patient Safety Research Unit.

An analysis was conducted of the causes associated with the increase in the incidence rate of CLABSI using the root cause analysis methodology (Figure 1). Once the causes were identified, these were prioritized by the improvement team, in accordance with the following criteria: the importance of the cause as a contributor to the problem, the possibility of improvement, the expected time frame for achieving an improvement or correction of the cause, and finally the investment in human and financial resources required for the intervention. The details of this prioritization analysis are shown on Figure 1. The following causes were prioritized in this exercise: 1. Lack of standardization of the insertion protocol criteria in the various services; 2. Lack of control and verification systems; 3. Inadequate implementation of the existing strategies; 4- Contamination of sterile solutions; 5. Non-availability of inputs or standardized packages or implementation methods; 6. Poor knowledge of the insertion protocols by all the staff members responsible for the procedure; 7. Poor compliance with the laboratory sampling technique, ports management, closed circuit; and 8. Unnecessary long term use of catheters.

Source: Authors.

Figure 1 Prioritization of CLABSI causes. A score between 1 and 4 was used; the causes with higher scores were prioritized for intervention. 

The causes prioritized were also classified into two groups, depending on the stage of care of the patient with a central catheter: stage 1: catheter insertion; stage 2: catheter care and maintenance.

Based on the above, the project was divided into two intervention phases, each with a direct goal which could contribute to achieving a reduction in the Incidence Rate of CLABSI.

The following goal was established by the improvement team for Phase 1: A reduction in the rate of bacteremia associated with catheter insertion in adult ICU patients to less than 50 % of the last year average in a period of 12 months (a reduction to 3.5 cases x 1,000 days -catheter).

The second goal was to reduce the incidence of events in the institution involving care and maintenance of catheters in services outside the ICU. Phase II goal of the project: to reduce the rate of catheter-related bacteremia due to catheter care and maintenance in hospitalized adults, to 0 % within a period of 12 months (reduce the incidence of catheter-related bacteremia to 0 cases x 1,000 days-catheter outside the ICU).

Once the goals were established, a flow diagram was developed indicating the primary and secondary aspects requiring intervention, and what had to be improved based on the hypothesis submitted by the improvement team. The details of the flow diagram are illustrated in Figures 2 and 3.

Source: Authors.

Figure 2 Flow diagram to guide the CQJ strategy during Phase I of the project. 

Source: Authors.

Figure 3 Flow diagram to guide the CQI strategy during Phase II of the Project. 

To assess the effectiveness of the CQI intervention, a time series analysis was conducted on the effects of improving the care systems based on quantitative indicators of processes and outcomes. These indicators were identified during the development of the program through continuous quality improvement methods. The outcome indicator was the rate of catheter-related bloodstream infections expressed in number of cases per 1,000 days - catheter.

RESULTS

After completing the root cause analysis and prioritizing the areas and processes requiring intervention at each phase of the project, a number of ideas for improvement were submitted and approved. The improvement team, together with several members of the clinical teams, held a number of discussions that led to the proposal and prioritization of ideas for improvement. Then, using prioritization matrixes considering the impact criteria and the time required for implementation and results, the improvement ideas were prioritized and a schedule for the interventions was set. Phase I of the project began on September 2018, and nine months later - June 2019 - Phase 2 was initiated. Figure 6S of the Complementary material summarizes by way of an example, three aspects and processes subject to intervention with the ideas approved in each cycle during Phase I of the improvement project.

The process indicators and outcomes suggested were measured on a weekly basis.

During the intervention phase in 2018, an immediate reduction down to zero was observed in the incidence rate for October and November of that same year. However, there was an increase in December - 7,7 cases per 1,000 days - catheter - (Figure 4). Considering that the interventions being implemented in the institution were for the period consistent with Phase 1 of the project, intended to improving catheter insertion and hence reducing de development of bacteremia during the first 72 hours, the team conducted a stratified analysis of the incidence of CLABSI cases that became symptomatic after 72 hours. The analysis which began in January 2019, showed that the incidence rate of CLABSI in the institution over the first few hours was zero, from January through October 2019, when the measurements were discontinued (Figure 5).

Source: Authors.

Figure 4 Behavior of pre-implementation CLABSI and changes during the implementation of the CQI strategies. 

Source: Authors.

Figure 5 CLABSI incidence rate over the first 72 hours post-insertion, from January through October, 2019. 

On the other hand, the cases that developed after 72 hours whose cause -based on time criteria - could be attributed to catheter maintenance was variable, with values ranging from 4.7 to 10.31 cases per 1,000 days-catheter, between January and July, 2019. These values decreased down to zero, after one month of initiating Phase 2 of the project which focused on improving the processes relating to catheter maintenance in the institution, and extended to hospitalization areas and other areas delivering care to patients users of this device. The trend observed in this analysis, considering that the cases developed 72 hours after the catheter insertion, also showed a decreasing trend with constant zero values for the months of August, September and October, when the measurements were discontinued (Figure 6).

Source: Authors.

Figure 6 Incidence rate of CLABSI events developed over the 72 hours post-insertion, from January to October, 2019. 

Significant improvements were also visible in terms of process changes, with regards to compliance of the hands hygiene protocol, skin preparation, use of garment packages and catheter insertion supplies prepared by the pharmacy, and uses of the personal protection equipment throughout the insertion procedure by the team members. Sustained improvements were achieved in all the indicators, exceeding the thresholds established as process goals by the project improvement team; this is indicative of a change in the patient safety culture of the healthcare team. The behavioral details of these indicators according to the control charts, are illustrated in Figures 1S to 5S of the supplements.

The qualitative analysis of the factors accounting for the variability of the processes, and hence of the results of the measurements of the process indicators, showed that employee turnover with new residents or new staff joining the clinical teams, as well as end-of-the-year season, which is consistent with changes in work hours, were all factors associated with the decline of some indicators. Consequently, catheter insertion and maintenance protocols dissemination and training were implemented as mandatory activities at the institution, in addition to academic activities for students specializing in the ICU.

DISCUSSION

Healthcare associated infections represent a major challenge for most health institutions, not only because of the implications with regards to compliance with quality standards, but also because of the potentially catastrophic consequences for patients and high utilization of health system resources.

In this study, the implementation of measures aimed at standardizing the insertion, asepsis and antisepsis processes, and the use of maximum barriers - all evidence-based measures which responded to the needs identified in the root-cause analysis - led to a rapid and sustained decline in the incidence of CLABSI in the institution. Maintaining these measures required auditing, strict feedback, and dissemination of all the measures among the clinical and administrative staff of the institution.

The segmentation of the catheter insertion process and maintenance helped to accomplish the goal with the resources available in the institution, while educating the clinical team members and the leadership of the institution, on the improvement methodology. This finding may be helpful for the implementation of measures addressed to complex systems and processes in settings introducing the CQI method to manage clinical risk. Efficiency improves based on the prioritization of actions and compromised process areas whose intervention results in a rapid impact on clinical outcomes.

Beyond showing a reduction in clinical outcomes, which is consistent with similar projects in other geographies (¹³-¹⁶), this study is intended to show practical details that facilitate the implementation of strategies designed for a swift and efficient achievement of the goals, particularly with regards to strengthening the patient safety culture, focusing mainly on events associated with intravascular devices and others routinely used as a patient monitoring strategy.

The immediate impact after introducing the interventions may be partly due to the effectiveness of such recognized and evidence-based interventions, but also due to the Hawthorne effect; However, their sustainability over time is an indication of the cultural change in the standardized practices of processes such as catheter insertion and maintenance.

Some of the limitations of this study include: first, there were no longer term measurements available to establish the definitive reduction in the maintenance-related CLABSI incidence rate, in addition to the sustainability of the improvement achieved towards this goal. Second, failure to establish indicators to quantify the changes in the culture of safety over time. These aspects support ongoing and future research projects.

CQI is a feasible risk management system to be implemented in the search of solutions to complex situations affecting patient safety at high complexity healthcare institutions in the Colombian setting. It is important to consider future studies addressed to estimate the impact in terms of use of resources and institutional cost savings, in order to establish the cost-effectiveness of these measures.

CONCLUSION

This paper showed the effectiveness of the CQI method to achieve a significant reduction in CLABSI at the institutional level, its sustainability and resulting healthcare process changes, suggesting changes in the patient safety culture of the participating teams. These lessons and improvement cycles may be used at other institutions and applied to the context of other various devices.

The results show that the continuous quality improvement method enabled the identification of areas susceptible to errors in the insertion of catheters and their maintenance at the institution. Additionally, CQI allowed prioritizing the areas to be intervened and building work teams that defined interventions to be implemented in consecutive test cycles. Finally, the process indicators were developed and the outcomes identified to measure the impact of the interventions. The goals initially set for the incidence rate of CLABSI were accomplished in several process indicators.

ETHICAL DISCLOSURES

ACKNOWLEDGEMENTS