By Suzanne Gavigan and Raji Thomas
Unintended retention of foreign objects (URFOs) – also called retained surgical items (RSIs) – after invasive procedures are Sentinel Events reportable to The Joint Commission. Patients who experience a retained surgical item may sustain both physical and emotional harm, depending on the type of object retained and the length of time it is retained.
A review of the Sentinel Event (SE) database from 2010-2020 indicates that a total of 326 events were reported for health care organizations in the Ambulatory Health Care Program (AHC). Of those events, 40 were classified as URFOs, which was the second highest frequently reported event. URFOS were second only to wrong site procedures. These preventable adverse events have been estimated to occur in 1 in every 5,500 surgeries.
Regardless of severity of harm, every incident of URFO results in three victims: the patient who was the recipient of care; the health care team that operationalized the care processes which broke down and allowed harm to reach the patient; and the health care organization that may suffer from loss of reputation or esteem in the community if individuals involved share the occurrence with friends and family, and/or post to social media. Developing reliable systems of care is incumbent for every health care organization that provides surgical services to maximize their patients’ outcomes and to avoid URFO.
Defining and Reporting URFOS
URFOs are Sentinel Events by Joint Commission definition. As outlined in the Comprehensive Accreditation Manual for Ambulatory Care (CAMAC), “Sentinel Events are a subcategory of adverse event, not primarily related to natural course of patient’s illness or underlying condition and results in death, severe harm, or permanent harm.” Some specific harm events that reach a patient are added to the definition as stand-alone items. Adding stand-alone line items to the definition allows review of events that may, or may not, result in death, permanent harm, or severe temporary harm, but are considered serious events where harm reached a patient because of system failures.
In addition, updated language specific for reporting a URFO as a sentinel event has been added to CAMAC section, “Unintended retention of a foreign object in a patient after an invasive procedure, including surgery.¹” To add further clarification, the footnote defines: “The time after an invasive procedure encompasses any time after the completion of final skin closure, even if the patient is still in the procedural area or in the operating room under anesthesia. A failure to identify and correct an unintended retention of a foreign object prior to that point in the procedure represents a system failure, which requires analysis and redesign. It also places the patient at additional risk by extending the surgical procedure and time under anesthesia.”
Root Causes and Prevention Strategies
What causes URFO cases? Leadership, human factors and communication were the most frequently identified root causes for URFO cases during 2010-2018.
Leadership breakdown is further defined as: failure to follow policy and procedures; failure to determine counts as expected; failure to complete established processes when count is identified as incorrect; hierarchy/intimidation issues; lacking relevant policy; and equipment not in place.
Strategies to Improve Leadership Sustainment of Safety Culture
- Prioritize a culture of safety²
- Conduct proactive risk assessment²
- Respond to errors with focus on process improvement using human factors analysis regarding any identified URFO or near miss [3]
- Allocate resource for education, training and audit²
- Report events of retained fragments to manufacturer²
- Implement policy and procedures based on current evidence-based literature and self-monitor that all team members are following the process
- Determine process for counts when team undergoes break or shift change
- Limit number of people in procedure room to help prevent distractions
- Human factors that cause error include inadequate team training; anchoring bias; assumptions; lack of situational awareness; rushing; normalization of deviance around count process; and failure to follow established procedures.
Strategies to prevent human factor error
- Provide team training such as TeamSTEPPS[2,3]
- Address disruptive behavior²
- Minimize distractions, noise and interruptions[2,3]
- Educate risks for occurrence of URFO and mitigation strategies[2]
- Assess competency of staff regarding count process and next steps if additional actions warranted at any time during or immediately following procedure
- Establish uniform documentation across all procedural areas[3]
- Reconcile the count so the entire team is involved[3]
- View counts concurrently by two individuals, including circulating nurse[3]
- Standardize layout of procedural areas to help staff locate equipment and supplies in comparable areas if working in new location
- Adjust lighting to enhance visibility
Communication breakdowns noted with inadequate communication of count process, inadequate team communication, staff not speaking up.
Strategies to improve communication
- Use a whiteboard to communicate insertion of devices[2]
- Call out when instrument placed in body cavity has not been immediately removed[2,3]
- Alert team when packing is placed and not immediately removed; discuss need for packing removal during handoff[2,3]
- Physician voices affirmation that the count is correct prior to completion of skin closure
- Discuss removal of objects during debriefing at conclusion of case[2]
- Verbal affirmation by the team that the patient meets criteria for an intraoperative X-ray to screen for URFOs
- When ordering an X-ray for ruling out URFO, provide description of object[2]
- Develop process with radiology colleagues for ordering X-ray for URFO and reporting results of study in a timely manner
It is imperative that ambulatory surgery centers (ASCs) recognize the risk of human interaction during complicated and ever-changing technical processes, since URFOs continue to present risk to vulnerable patients undergoing surgical procedures. ASCs should strive to maintain reliable systems that include layers of protection, to assist health care leadership complete complex tasks. Focus and accountability is required for all members of the ambulatory surgery team.
The best way to prevent URFOS is by addressing the most common vulnerabilities with consistent processes, rooted in evidence-based literature. Following these processes will help maintain reliable systems for safe care and strengthen staff confidence in their ability to provide successful outcomes to all who seek their care and expertise.
For more information about URFOs contact The Joint Commission’s Office Quality and Patient at seu@jointcommission.org.
– Suzanne Gavigan, MSN, CRNP, CPPS, is the associate director of the Office of Quality and Patient Safety at The Joint Commission.
– Raji Thomas, DNP, MBA, CPHQ, CPPS, is the director of the Office of Quality and Patient Safety at The Joint Commission.
References
[1] Comprehensive Accreditation Manual AC Update 2 January 1, 2022, release
[2] Steelman VM, Shaw C, Shine L Hardy-Fairbanks AJ. Unintentionally Retained Foreign Objects: A Descriptive Study of 308 Sentinel Events and Contributing Factors. Jt Comm J Qual Patient Saf 2019; 45:249-258.
[3] Wallace SC. Retained Surgical Items: Events and Guidelines Revisited. PA Patient Safety Advisory. 2017 March;14(1)27-35.
[4] The Joint Commission, Division of Healthcare Improvement. Strategies to prevent URFOs. Quick Safety 2016. Jan;(20):1-3.
