Operating rooms have successfully implemented use of protocols and tools such as safety checklists to mitigate patient harm from omissions in documentation. These tools have enhanced provider-to-provider communication by empowering team members to speak up with questions and concerns before the procedure (Wright, 2016). Checklists are a well-established and simple standardized tools for clinicians to point out discrepancies that can lead to patient harm, yet there is a paucity of their use in gastroenterology endoscopy units (Mason et al., 2018).
Structured communication patterns enable clinicians to stay focused and avoid distractions that may lead to patient risk. According to the Agency for Research and Health Care Quality (Agency for Healthcare Research and Quality Patient Safety Network, 2019), most errors in healthcare occur as a result of “slips.” In cognitive psychology a slip is a mistake in schematic behavior, which are those tasks performed on autopilot due to distractions or fatigue. Since the introduction of the Surgical Safety Checklist (SSC) in 2009 as part of the World Health Organization Safe Surgery Saves Lives Campaign complication rates decreased from 11% to 7%, surgical site infections from 6.2% to 3.4%, and in-hospital death rates from 1.5% to 0.8% (Jain, Sharma, & Reddy, 2018). Despite these significant results and associated benefits of safety checklists, inconsistent use or adoption has been an issue. This could be attributed to lack of physician engagement in the process related to the hierarchical culture of healthcare and perception that safety checklists cause procedural delays (Jain et al., 2018), lack of leadership support, lack of checklist customization to specific practice setting, and redundancy in work (Gillespie, Withers, Lavin, Gardiner, & Marshall, 2016).
Failures in communication among the healthcare team can have a financial impact. From 2009 to 2013, Crico Strategies, a division of The Risk Management Foundation of the Harvard Medical Institutions Incorporated, identified that 30% of malpractice cases involved communication failures contributing to patient harm. This represented $1.7 billion in losses through their Comparative Benchmarking System (Crico Strategies, 2015). Thirty-nine percent of these cases involved provider to–provider miscommunication and reflected insufficient, inaccurate, delayed, or illegible documentation. Incomplete documentation to guide patient care raises the odds of indemnity malpractice payments by 90% (Crico Strategies, 2020).
Endoscopy settings are normally high-volume caseload areas where timely throughput is desired to prevent procedural delays. Being a fast-paced environment, the endoscopy procedural setting is susceptible to gaps in documentation and handoff communication posing patient safety risks. These production pressures, distractions, and rushed timeouts contribute to errors due to poor communication as a major contributing factor in wrong site, wrong procedure, and wrong patient procedure (Agency for Healthcare Research and Quality Patient Safety Network, 2019; The Joint Commission, 2020).
The gastroenterology endoscopy unit at a 673-bed academic medical center, located in Boston, Massachusetts, and affiliated with Harvard Medical School, performs approximately 25,000 endoscopy procedures per year. This creates many patient encounters and clinical handover opportunities during an endoscopy procedure. In 2018, a survey by The Joint Commission (TJC) found pre-procedural documentation gaps in the medical center's endoscopy units that could present patient risk. Lack of completeness and legibility of the consents were cited by the TJC survey.
The TJC findings prompted the endoscopy team to initiate a quality improvement (QI) project. The team create an endoscopy-specific checklist to be used by the whole procedural team, including the patient. This is completed simultaneously during a time-out as part of the pre-procedural sedationpre-procedural sedation Universal Protocol in two endoscopy units; general and advanced endoscopy. The authors wanted to assess whether the use of an endoscopy safety checklist improves clinical documentation compliance by addressing gaps that may pose safety risks for safe patient outcomes. The goal was to encourage clear and consistent team communication, including the patient through the use of the checklist.
This QI initiative focused on the incorporation of an endoscopy-specific checklist (Figure 1) into the daily procedural workflow within two gastrointestinal endoscopy units of a 673-bed academic medical center located in Boston, Massachusetts. Being a QI initiative, the Institutional Review Board approval was waived.
The authors used a chart abstraction tool to accurately identify areas of communication where deficiencies had occurred. The chart abstraction tool allowed for auditing of variables where lapses in documentation occurred, which ultimately assisted in the creation of the checklist. The checklist consisted of items pertaining to the review of patient identification, comorbidities, allergies, procedure indication, anticoagulation plan, monitoring, and IV access. The presence of these specific items on the checklist allowed for a complete investigation and verification of critical patient pre-procedure physical and medical assessments required to safely administer procedural sedation (Practice Guidelines for Moderate Procedural Sedation and Analgesia, 2018). Two checklist items, the presence of correct scope and correct screen for procedural reporting software, were included based on applicability to the two endoscopy units' specific pre-procedural workflow. The authors created the checklist with intentional simplicity to encourage adherence and compliance. The checklist is aligned to the medical centers' institutional policy and procedural requirements for interventional procedures and vetted by the medical center's Interventional Procedural Committee.
Following checklist development, two experienced endoscopy nurses were asked to trial the tool and provide feedback. The Plan Do Study Act (PDSA) cycle for process improvement (Institute for Healthcare Improvement, 2019) was used to make adjustments to the checklist based on user feedback; the first of which occurred after this initial trial. The nurses suggested the tool should be used concurrently with the Universal Protocol, a standard practice performed immediately before sedation in the procedure rooms. The checklist was endorsed by endoscopy medical and nursing leadership. The team was educated in the use of the tool through staff meetings, newsletters, email, and one-on-one instruction as needed. Faculty meetings led by the Gastroenterology Division Chief provided a vehicle to instruct and encourage physician participation and set compliance expectations. Additionally, checklist items and their rationales (Figure 2) were printed and laminated for reference and placed in each procedure room. Endoscopic checklists accompanied all procedural patients' medical record paper charts used within the endoscopy units.
In this institution, the procedure nurse and the endoscopy physician follow a standard pre-procedural pause called hard stop. The procedural team performs the Universal Protocol before administration of patient sedation. Adding the use of the endoscopy safety checklist concurrently with the Universal Protocol made it a natural extension of this well-established safety measure. During this hard stop, all clinicians involved in the procedure verify accura, legibibility, and completeness of documentation using the checklist. Before undergoing sedation, the procedure team reviews the pre-procedural process with the patient. The introduction of a checklist addresses clinical documentation gaps while eliciting team communication and patient participation in the process.
Right after initiating the checklist trial in all procedures, a second PDSA cycle was done and provided feedback from users that resulted in additional checklist items. Were there illegible chart entries? Were the procedural consent forms dated and timed by the physician and the patient? Frequent leadership check-ins, observation, champion support, and individual participant clarification helped in maintaining checklist compliance. To continue to foster collaboration and engagement, staff was encouraged to provide ongoing feedback. Leaders share positive audit results of tool use at staff meetings and on one-on-one interactions. This underscores the importance of the pre-procedural checklist as an important safety measure for every procedure rather than just a tick-box exercise.
The procedural team conducted a pre-intervention audit of 201 procedural patient charts during the month prior to the implementation of the endoscopy-specific checklist. The team noted 18 missing reports. Gastrointestinal procedural records, including but not limited to endoscopy and colonoscopy, were examined and audited for completeness (see Table 1 for all types of procedures measured). After pre-intervention data collection, the checklist tool was piloted over a 10-day period. Post-intervention data were collected in two parts.
TABLE 1. -
Procedure Types Measured
|Top 4 Procedure Types
|EGD and colonoscopy
Note. EGD = esophagogastroduodenoscopy; ERCP = endoscopic retrograde cholangiopancreatography.
An audit of 120 procedural charts was conducted to verify compliance with checklist utilization and checklist completion. Next, a comprehensive chart audit was performed. The same 120 procedural charts were reviewed to confirm that all items verified as completed on the endoscopy safety checklist matched with all item entries located within the patient clinical procedural record. There was one missing report. This institution uses a paper procedural record including history and physical and nursing documentation. The medical records team collect and scan into the permanent electronic patient record team collect. Because of this manual exercise, some medical charts may not have been available at time of audit to include in this analysis due to scanning delays.
During the course of the checklist pilot, 25 physicians and 40 endoscopy nurses used the endoscopy safety checklist pre-procedure and before initiating sedation. Table 2 summarizes checklist item completion performance in the endoscopy department before and after checklist implementation.
TABLE 2. -
Data Analysis Summary: Summary of Pre/Post-Tool Analysis
|Count of files reviewed
|Consent for procedure present, signed, dated, and timed by provider
|Consent for procedure present, signed, dated, and timed by patient
|Pre-procedure checklist completed, signed, dated, and timed
|Indication for procedure noted
|Planned procedure noted
|Chart preparation section completed
|Patient preparation section completed including allergies
|Peripheral intravenous access noted with location and gauge
|Pre-procedure assessment completed
|Clinician pre-procedure assessment completed (relevant laboratory tests optional)
|Clinician pre-procedure assessment signed, dated, and timed
|Clinician pre-procedure legible
|All question average
After normalizing the data set and utilizing the χ2 test, most measures showed statistically significant improvement in performance. The only exceptions were items where full compliance had been achieved at baseline and remained in compliance after implementation of the checklist. These included comorbidity, noted anticoagulants and indication for procedure.
Areas with most significant improvement were related to consent completeness (33.5%) and legibility (37.5%) and both nursing and physician assessment pre-procedure. Pre-procedure checklist completion refers to the nursing-assessment portion, which saw a 27.1% improvement and the pre-procedure assessment refers to the physician assessment, including the American Society of Anaesthesiologists (ASA) score and airway assessment, which improved by 28.8%.
Although the checklist use was adopted easily in the general endoscopy unit, it was noted to be more challenging in the advanced endoscopy unit. The procedural team is larger in the advanced endoscopy unit, leading to more interdisciplinary interaction between the team and the patient. All procedures in this unit have an anesthesiologist administering the sedation and monitoring the patient, compared to the general endoscopy unit that has a mix of anesthesia and moderate sedation administered by the endoscopy nurse. Observations during the trial discovered that, at times, the anesthesiologist would start sedation before transferring the patient to the procedure room, after consent was obtained, while the procedure nurse and the endoscopist were preparing in the procedure and control rooms. This made it difficult, if not impossible, to include the patient in the process. While the patient still had input regarding the sedation plan when discussing with the anesthesiologist pre-procedure, there was no consistent communication between the whole healthcare team involved regarding all checklist items. Feedback from the team suggested the checklist process in this unit would contribute to delays.
This practice improvement project aimed at addressing the deficiencies noted in the TJC survey related to incomplete and illegible documentation. The use of an endoscopy safety checklist improved clinical documentation compliance, addressing documentation gaps that may pose safety risks for patient outcomes. It also aimed to enhance the healthcare team's communication facilitated by the use of the safety checklist pre-endoscopy procedures.
The most notable findings related to improvements through use of the checklist were related to physician documentation completeness and legibility. This suggested the checklist prompted clarification of documentation and communication by the nurse leading the checklist process and the physician performing the procedure. Areas of nursing pre-procedure assessment in the intake area and before entering the procedure room saw a 27.1% improvement. This suggested improved clinical handover between the admitting and procedural nurses. The healthcare team reported an improvement in overall communication. Other research in the use of safety checklists has found similar results of positive perception of enhanced teamwork, communication, and collaboration, as well as the importance of patient participation (Dubois, Schmidt, Creutzfeldt, & Bergenmar, 2017; Kherad, Rostellini, Menard, Martel, & Barkun, 2018).
Limitations of this QI project included difficulty adhering to the checklist process in the advance endoscopy unit. Suggesting one size does not fit all when developing a safety checklist process. Specific workflow must be considered in customizing checklists and process to ensure success. Even though the two endoscopy units are staffed by the same nurses and providers, the team has more interdisciplinary members within the advanced endoscopy unit, making compliance more difficult to achieve. The advanced endoscopy unit adds to the procedural team interventional techs, advance practice fellows, researchers, and anesthesia providers, whereas the general endoscopy unit procedural team primarily includes the endoscopy physician and the procedural nurse.
The Hawthorne effect may have also played a role in compliance during observations by champions and leadership. Checklist audits post-procedure found nearly 100% compliance with the actual check box exercise that the checklist entailed, yet the chart reviews did not show 100% compliance. This indicated that at times, nurses may have been checking off the boxes on the checklist without actually verifying the checklist item in the patient chart. Despite this limitation, improvement was seen in all checklist categories except where compliance was already achieved at baseline. In this project, the observations contributed to an understanding of how the checklist was used by the team. Knowing that people tend to behave differently when being observed, future observations to ensure sustainability may be done by members of the team while doing their ordinary tasks in an effort to minimize this bias.
Pre-procedural checklists are effective tools to mitigate patient harm during endoscopy procedures as this pilot demonstrated. Continued leadership support and engagement of nurses in the process is necessary to maintain compliance. Transparent and frequent audit data sharing is beneficial in encouraging the use of the checklist as a worthwhile exercise to promote patient safety. The endoscopy units continue to use the safety checklist at the medical center achieving sustained improvements in chart audits. Although not measured in this pilot project, there is evidence of improved team communication driven by the use of the checklist. This could be contributing be a factor in the continued efficacy of the safety checklist. Physician and nursing leadership support have promoted this QI initiative in the general endoscopy unit and found to be key to sustainability. Work is ongoing to improve checklist use in advanced endoscopy. The goal is to engage the interdisciplinary healthcare team in to devise a more sustainable checklist workflow.
Implications for Practice
As the endoscopy procedural field becomes more technologically advanced, complete documentation and pre-procedural assessment by the healthcare team that involves the patient in the process can mitigate harm. By ensuring the whole team is on the same page and aware of the patient condition and history that may impact their procedure, complications can be prevented. Endoscopy nurses are coordinators of patient care in this procedural setting and are well-positioned to engage the care team in consistent safety practices. Healthcare quality and patient safety have been improved through the use of safety checklists such as the World Health Organization checklist. The success of this project with sustained positive results can be a valuable patient safety tool in endoscopy. A key benefit found in the use of the endoscopy safety checklist through this QI project was consistent team communication. Further research is needed regarding teamwork culture when utilizing such tools.
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