Abstract. Procedural checklists are used in a wide variety of industries, ranging from aviation to healthcare. The goal of a checklist is to reduce variability in practice with the goal of improving patient safety and outcomes. In healthcare, improving the reliability of treatment processes or interventions by reducing variability in how interventions are delivered has been shown to improve patient morbidity and mortality outcomes. To improve reliability of processes in a hospital-based cardiovascular lab, the World Health Organizations Safe Surgery Checklist was implemented.
The checklist was initially used on pacemaker and defibrillator insertions, with the intention of slowly expanding it to other procedures over time. The quality improvement project was scheduled to run over an 8-week period in 2020, which ended up being in the midst of the Covid pandemic. There were a number of challenges to implementing the project, including decreased staffing levels that were a direct result of the pandemic, existing workflow, and staff resistance to deviating from current practice. Despite difficulty with implementation, procedural checklists are a useful tool to improve staff communication and patient safety.
Medical errors are the third leading cause of death in the United States (U.S.).1 Over an 8-year period in the U.S., there were more than 250,000 deaths each year due to medical errors.1 Ineffective communication, a high-stress work environment, and a lack of interdisciplinary teamwork can all contribute to the risk of medical errors.2 The World Health Organization (WHO) also identifies procedural complexity as being a contributor to poor patient outcomes, as well as problematic for patient safety.3 As procedural complexity increases, there is often a corresponding increase in the number of steps required for that procedure. Each additional step is a potential error point that, if missed, can decrease patient safety. A simple and cost-effective way to reduce the possibility of errors is to incorporate the WHO Surgical Safety Checklist,4 recommended as best practice by both the WHO and Agency for Healthcare Research and Quality (AHRQ).4,5 According to the Institute for Healthcare Improvement (IHI), for many conditions with well-defined criteria for the best treatment, only about 50% of the recommended care is ever delivered.6 Along with gaps in delivery of recommended care, medical errors affect 10-20% of patients in the U.S. each year. Major surgical complication rates are between 3-22% in developed nations.3 After the introduction of the WHO Safe Surgery Checklist in a single center, infection rates fell by 50%,7 constituting a significant improvement in mortality and morbidity. Based on multiple studies with similar findings, the AHRQ concludes that procedural checklists should be used in all hospitals and departments where procedures are performed.8 The Surgical Patient Safety System (SURPASS) trial demonstrated a 47% decrease in mortality of surgical patients.9 The use of a checklist in the preoperative setting has been shown to decrease surgical complications, including reoperation, readmission, length of stay, and mortality.10
The Quality Improvement Project
Our cardiovascular lab (CVL), located within a large healthcare center in the western region of the U.S., was not aligned with best practice for a procedural area as defined by the WHO, due to the lack of a procedural checklist. We undertook a quality improvement project in order to align our practice in the CVL with recommended standards from the IHI, AHRQ, and WHO, through the use of a procedural checklist.
Self-evaluation. An initial organizational assessment and SWOT analysis helped us to evaluate our workflow, and team strengths and weaknesses. The organizational assessment examined the CVL staff and procedural workflow. A problem that was identified was a limited amount of time allotted for room turnover, prep time, and retrieval of specific equipment and supplies. We found staff had an inconsistent practice related to medication labels on the sterile field when working in the scrub role. A recommendation was made to modify the current practice and educate staff to label medication in the same technique recognized by the Association of Operating Room Standards (AORS).11 The SWOT analysis identified internal strengths of our CVL, including interprofessional staff members who function well as a team, a patient-centered care model, and staff that desired to provide safe and effective patient care. Internal weaknesses were the staff turnover rate, an omitted preoperative checklist, no formalized brief report prior to the procedure, and no debrief after the procedure. Opportunities identified through an external analysis identified IHI and the WHO current practice for using a checklist, reports pre and post procedure, and medication labeling.12,13 Areas determined to be potential threats for implementing change included low levels of interprofessional team involvement, an expectation of training involved with the use of a preoperative checklist, brief reports, and timely medication labeling.
Project Timeframe. Our modified version of the WHO Safe Surgery Checklist was initially limited to adult pacemaker and defibrillator insertions, with planned expansion to other procedures. The initial checklist implementation took place over 8 weeks. The first 2 weeks of the project consisted of staff education sessions regarding the WHO Safe Surgery Checklist. Importantly, along with education, staff members were shown a draft of the checklist and offered an opportunity to provide editorial feedback. This was done to help tailor the checklist to CVL procedures and workflow. Staff members provided several edits that were included in the final version of the checklist. The implementation of the checklist took place over the next 4 weeks, for all adult pacemaker and defibrillator insertion procedures. The final 2 weeks of the project were used to compile the findings and present them to the department administration.
About the Checklist. The WHO Safe Surgery Checklist is comprised of 3 sections, with each section completed at a different pause point prior to and during the procedure (Figure 1). Each section is designed to take no more than a minute to be completed. The first section was to be completed prior to the patient receiving sedation. The second section was to be completed prior to skin incision or sheath insertion. The last section was to be completed prior to the patient exiting the procedure room. The checklist was completed in a ‘Do Confirm Method’, which allowed individual operators to complete their tasks and then verify completion with another member of the team who completed the checklist. If any item was found to be incomplete, the team would pause and address the incomplete item prior to moving forward with the procedure.
To evaluate implementation of the checklist, 4 items were reviewed from the completed checklists:
1) Confirmation that a brief report was conducted prior to the patient entering the procedure room.
Confirmation of a brief report being conducted prior to the patient being brought into the procedure room was not achieved. This item was removed from the checklist during the editorial process at the request of the department staff. With limited time between procedures, the staff felt that it would be difficult to gather the entire team and physician. Staff felt that varied duties within the limited window would create difficulty in having the entire team huddle together. They continued with their existing practice of the team lead discussing the next case with the physician. The team lead was then responsible for relaying any pertinent information to the rest of the team.
2) Observation that all medication cups and syringes were correctly labeled prior to the start of the procedure.
Observing that all medication cups and syringes were labeled correctly prior to the start of the procedure was successfully achieved. This item was included as a Joint Commission requirement.13 The final version of this item included one edit from the department staff: the words “fluid filled” were added to this item in the final version of the checklist, done to ensure compliance with existing hospital policy forbidding the pre-labeling of empty syringes.
3) Completion of a debrief at the end of the procedure prior the patient leaving the procedure room;
Completion of a debrief at the end of each procedure was successfully achieved. This item was included from the original WHO checklist.4 It was marked complete on 100% of the returned checklists. This item is something that staff reported as being valuable and likely to be continued.
4) Completion of the checklist.
One hundred percent completion of the checklist was used as affirmation that the other items had been completed. All returned checklists were reviewed for completeness. This objective was partially met. There were 36 qualifying procedures completed during implementation of the checklist. Of the 36 qualifying procedures, 22 (61%) procedures had checklists returned. Only 5 of the 18 staff members in the department completed the 22 checklists.
At the beginning of this project, CVL staff consisted of 24 members. At its completion, 4 staff members had left for other positions and 2 were out on leave, for a total of 18 scheduled staff members. Inconsistencies in staffing made it difficult to provide staff with opportunities to use the checklist during the initial implementation. Existing practice was another challenge to implementation. This was demonstrated by the staff request to remove the preprocedural huddle from the checklist. Staff resisted this item, as it was felt to be too much of a departure from the established workflow. The intrinsic beliefs of the staff in the department provided an area of challenge to the project. Staff belief that their outcome measures are on par with national averages made some resistant to this project. They did not see the benefit of change since outcome measures were already acceptable. To help overcome this issue, staff members were presented with data supporting checklist use during staff education and training sessions. Staff members were also encouraged to offer editorial suggestions to the checklist to cultivate a sense of ownership. The Covid-19 pandemic, however, proved to be the largest challenge to the implementation of a checklist. Variations in staffing and procedure volumes contributed to uncertainty and stress among both the department and larger organization. The department utilized minimal staffing, having staff come for partial shifts or stay home on call due to lower case volumes. Only 1 or two 4-person teams were scheduled each day (prior to the pandemic, normal staffing consisted of up to 5 teams, made up of 3-4 staff each). To help balance departmental budgets due to the decreased caseload during the pandemic, staff was also required to take vacation time. These staffing changes directly contributed to the number of staff available to use the checklist. Procedure volumes were another challenge. During the early period of the pandemic, our cardiology group triaged patients to identify non-emergent cases and those who were least likely to have any adverse effects from delaying their scheduled procedure. This was done in effort to limit patients’ potential exposure to Covid-19. It was also reported that patients themselves canceled or rescheduled clinic visits as a result of the pandemic. This decrease in office visits also had a negative impact on case volumes during implementation. Prior to Covid-19, the CVL completed 15-25 qualifying procedures (adult pacemaker and defibrillator insertions) each week. Implementation of the checklist took place over a 4-week period where only 36 qualifying procedures were completed.
The goal of a checklist is to reduce variability in practice and improve reliability. We intend to expand our checklist to other procedures, to be accomplished on a quarterly or bimonthly basis. Timing rollouts of new quality improvement projects will help to guard against staff burnout associated with too many process modifications in a short time. Staff members were already adjusting to changes as a result of the pandemic, which will need to be considered as any other improvement projects are put forward. Including staff improves engagement and helps identify champions within the department. Champions can encourage and engage remaining staff with the checklist implementation and ongoing evaluation within the department. By expanding the use of procedural checklists, the CVL can continue to improve safety for patients. Despite persistent difficulties with implementation, procedural checklists are a useful tool to improve patient safety.
The authors can be contacted via Nathan Larason, BSN, DNPc, RN, at email@example.com.
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For Further Reading
Cahill TJ, Clarke SC, Simpson IA, Stables RH. A patient safety checklist for the cardiac catheterisation laboratory. Heart. 2014; 101(2): 91-93. doi:10.1136/heartjnl-2014-306927