Endoscopic procedures continue to remain a top patient safety focus in healthcare organizations. In 2024, it was estimated that the US performed around 80 million procedures, with an expected increase in volume (Grand View Research, 2024). Given the volume of procedures, the need for quick turnaround for procedure rooms, and staff turnover, patient safety presents a tangible challenge for both leaders and staff. Leaders and staff at all tiers within the endoscopic service line must be engaged in fostering a culture of safety that quickly identifies, addresses, and mitigates causes of patient harm.
Understanding the Requirements
Endoscopy is a complex medical procedure that comprises many of the more critical processes one may observe in the healthcare environment. It is also an area of high focus by regulatory teams, as endoscopic procedures have driven a significant number of patient care events. A common driver contributing to these opportunities that our consultant teams observe is that leaders and staff are often unaware of the requirements that guide safe endoscopic practice. These requirements encompass regulatory requirements, infection control guidelines, and instructions for use for equipment and supplies. Key considerations include:
- Know Your Accrediting Organization’s Requirements. Leaders and staff must be knowledgeable of the regulatory requirements of their accrediting organization that pertain to endoscopic procedures. There may be state regulations that prescribe practice guidelines as well. Leaders should coordinate with their regulatory readiness team to review and understand their requirements and determine if their practice is aligned. These requirements should be embedded in any organization’s policy and procedures. A gap analysis of endoscopic procedure policies should be conducted to ensure that any opportunities to update them are identified.
- Know Your Policies. Our consultants often find that endoscopic services are not aware of organizational policies that apply to their practice. Leaders should understand their processes and the policies that guide them. This would include any pre-procedure, intra-procedure, and post-procedure phase of the endoscopic process. The policies will vary greatly in topic from History and Physical assessment to patient identification, time out procedures, procedural fire safety, medication safety, infection control, moderate/deep sedation practices, patient monitoring, post procedure recovery, patient education, and discharge/transfer procedures. A gap analysis for alignment should be used to identify opportunities.
- Know Your Instructions for Use. Leaders and staff must understand the instructions for use (IFU) from the manufacturers of all equipment items and supplies. These IFUs include the use and maintenance for the endoscope, any cleaning and disinfection supplies and equipment, and any storage system for the endoscopes. These IFUs must be accessible to users for reference. Additionally, these IFUs can change, so it’s imperative that leaders have a process to ensure that they are using the latest guidance from the manufacturer. Leaders and staff should identify and obtain all IFUs for each piece of equipment, chemical, and supply item. A review of these IFUs should be made to ensure that staff are following their guidance. A process should be in place to identify when there are changes to the IFU so they may be incorporated into practice.
- Communicating the Requirements. Leaders must ensure that all staff are aware of regulatory, policy, and IFU requirements. This should be done upon orientation to the service line and periodically thereafter. Requirements should be integrated into training and competency assessment for staff. It is essential that the Licensed Provider (LP) staff are also made aware of these requirements and their role in ensuring compliance. Provider information packets are often used at many organizations to educate LP staff. Recommend that these information packets be designed with targeted content for the LP role.
Continuous Monitoring for Opportunities
Understanding and communicating requirements must be followed up with monitoring practice for alignment. Our consultant teams often find that endoscopic services with the most opportunities are often lacking an effective means in place to monitor for alignment with requirements. In these cases, leaders frequently indicate they are not rounding enough (or at all) or even aware of elements to review. Important considerations for monitoring include:
- Establishing Your Process. This should include the use of leader rounding, observational audits, and record review. Leader rounding is an excellent means to review general processes, seek input from staff, and provide an avenue of communication to staff. Use of checklists/audit tools that use a set group of criteria will help in aggregating data to determine if there are trending opportunities. Observational audits can be general or focused in their reviews. Record reviews should look for documentation compliance with assessments, pre-procedural tasks, monitoring during the procedure, and post-procedural events. The ability to use automated data mining from an Electronic Medical Record will help reduce manpower in the extraction of data; however, it may be necessary to review documentation manually to ensure qualitative measures are acceptable. Additionally, any actual or near-miss event reporting should be reviewed immediately to determine contributing factors and trends from previous events.
- Gather and Analyze Data From Rounding. Data from all monitoring processes should be analyzed for trends and identification of opportunities so they can be eliminated and/or controlled. Use benchmarking to compare performance with other practices, national standards, and evidence-based practice models to assess your organization’s performance. Establish baseline measures early on to compare to as you implement performance improvement efforts. Leaders should ensure they are doing necessary “deep dives” with data to validate observations. Furthermore, analysis should not oversimplify the assignment of contributing factors. Follow the guidelines of high reliability during analysis to get the most from your data gathering efforts
- Ensure Transparency of Monitoring Data. Ensure that leaders and staff are aware of monitoring observations, data trends, and analysis results. Include staff in work teams in data gathering and review to foster ownership of endoscopic processes. Report analysis of monitoring activities to quality, Medical Staff, and infection control leaders. Don’t hesitate to own underperformances and seek assistance from the executive suite to address complex issues.
- Initiate Performance Improvement Activities. Based on findings from monitoring activity analysis, implement performance improvements to address opportunities. Set goals for improvement efforts and share results with leaders and staff. Use your quality and performance improvement resources to assist in setting up and organizing your improvement project efforts to support success. Ensure that improvement projects are included in rounding and monitoring activities.
Fostering a Culture of Safety
Leaders and staff must ensure that a culture of safety underpins all activities. Without this, all initiatives will struggle. This requires all leaders, staff, and LPs to create an environment where patient safety is prioritized and actively promoted by all. Key considerations include:
- Leading by Example. Leaders who act ethically and demonstrate a commitment to following regulatory and policy requirements foster staff who are more likely to do the same. Staff who follow the same practice set an example for their peers. LPs who take the time to practice the requirements that they have learned set a tremendous example.
- Cultivating Open Communication. Staff should feel safe to report issues or concerns without fear of retaliation. Those who identify and report safety concerns should be celebrated. Near misses should be particularly recognized as stopping harm before it reaches the patient. Anonymous reporting systems can help organizations identify and address problems early and fix them quickly. The use of pre-procedural huddles where staff and LPs can freely voice concerns should be standard practice. Completing post-procedural huddles is an excellent means to address what went well with a procedure and what should be corrected.
- Accountability. Prompt and fair actions against noncompliance with regulatory requirements and organizational policy demonstrate an organization’s commitment to compliance and discourage repeated mistakes. Addressing noncompliance should always focus on the care of the patient and not on a “shame and blame” of the staff member. However, it should be understood that leaders, LPs, and staff members will be held accountable for blatant disregard for established policy and patient safety protocols.
Summary:
Ensuring that an organization knows and understands requirements, observes and monitors performance, and fosters a culture of safety are instrumental in supporting safe patient care with the complexities of endoscopic procedures.
For questions or to learn more, contact the C&A team at 704-573-4535 or email us at info@courtemanche-assocs.com.
