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NoThing Left Behind®: A National Surgical Patient-Safety Project to Prevent Retained Surgical Items

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*** Newly Revised - 2015 Prevention of RSI Policy ***
*Sponge ACCOUNTing System Video available to view*

Retained Surgical Items

The problem of surgical items being inadvertently left in various body spaces after an operation, has been with us since the practice of surgery began. Retained Surgical Items (RSI) is the preferred term rather than retained foreign bodies or objects or uRFOs. Foreign objects include swallowed pennies, pins, shrapnel, bullets and other objects while surgical items are the tools and materiel that we use in procedures to heal not to harm. Retained surgical items are a surgical patient safety problem.

Here we have followed the AORN classification of surgical items and placed them into four groups; soft goods, sharps, instruments and small miscellaneous items. We have outlined safe strategies to prevent retention of each. It has been estimated that 2000 – 4000 RSI cases occur each year in the United States although we know from reporting systems that there is a wide spectrum of occurrence. Many hospitals have had no events for years while other facilities grapple with an event every quarter.

Requirements for state reporting vary as does the definition of what is considered retention. The National Quality Forum (NQF) definition is most frequently referenced. In 2011 the NQF reviewed all Serious Reportable Events (SREs) and posted on their public website the definition of when it is after surgery and all the SREs including unintended retention of surgical items.

The new directive excludes reporting of unremovable items intentionally left at the judgement of the clinician and most importantly has addressed the definition of when it is AFTER SURGERY. The operation ends after all incisions or procedural access routes have been closed in their entirety, devices have been removed and, if relevant, final surgical counts have concluded and the patient has been taken from the operating/ procedure room. The concepts extend to include spontaneous vaginal births as procedures that should not have unintentionally retained items and a working definition from a NoThing Left Behind OB/GYN consensus group is a vaginal birth ends when the mother is in the immediate recovery period (1-2 hours post birth). These are important reporting clarifications and we may soon see a decrease in event frequency just from these reporting changes since many cases of RSI have been reported because of requirements surrounding wound closure definitions. It is much clearer now, a surgical item isn't considered to be retained unless it is found to be within the patient AFTER the patient is out of the OR.

In October 2013 The Joint Commission (TJC) issued a Sentinel Event alert: Preventing unintended retained foreign objects. This is the most recent ruling from TJC and in this document there is NO explicit definition of when an item is retained. TJC references back to requirement EP 7: The leaders define "sentinel event" and communicate this definition throughout the organization". Therefore the use of the NQF definition of when it is "after surgery" and therefore when a surgical item is retained should stand all healthcare entities in good stead with reporting requirements.

RSIs can be discovered hours to years after the initial operation and a second operation may be required for removal. This type of case is a “canary in the OR coal mine” and is reflective of system problems in the operating room. It is rarely the result of a single individual error. New ways of thinking about human error and OR practices and understanding systemic changes in OR culture are required to prevent this event. System fixes require knowledge and information, a winning strategy, consistent multi-stakeholder engagement and leadership.

Using Sir James Reason's swiss cheese analysis of the latent factors and failed defenses which contribute to error, these cases represent problems in communication between perioperative care personnel and problems in perioperative practices(examination of the surgical wound, accounting procedures for surgical items, the taking of x-rays and their interpretation). In this way, RSI cases share characteristics with other surgical patient-safety problems such as "the wrongs" (wrong site, patient or operation), and surgical fires.

The most frequently retained surgical item is the cotton gauze surgical sponge which is available in a number of different sizes. Most reports of retained sponges refer to the 4"x4" raytex (an acronym we have coined to refer to a radiopaque textile) or the 18"x18" laparotomy pad. There have also been cases of retained OR towels. The most common sites are the abdomen/pelvis, the vagina and then the chest, although sponges have been retained in surgical wounds of every size and after almost any operation. Increased appreciation has occurred around the problem of retained vaginal sponges and miscellaneous items left behind after spontaneous vaginal births as well as elective gynecological operative cases. This has led to efforts to move better safety and preventive strategies to labor and delivery areas in addition to the OR and other procedural areas.

With retained sponges under better control, now we are seeing increased reports of retained small miscellaneous items, devices and unretrieved device fragments. These include intact but separated parts of surgical items, some of which are not radiopaque, broken pieces of instruments, small microneedles, trocars, guidewires and sheaths. These events occur in the OR and throughout the hospital and involve a wide variety of procedural items and an expanded list of provider stakeholders. The preventive strategies for these types of items are not applicable only to the OR since retained guidewires, sheaths and catheters are found after interventional vascular, cardiac and radiological procedures. Various types of providers now must develop standardized processes to account for all of the tools and parts of devices. Practices originating in the OR can be shared with these other clinical groups to help prevent retention and speed accountability.

In the Institute of Medicine report - To Err is Human - three domains of care were outlined: Safe Care, Standardized Care and Customized Care. At the time the report was written, most healthcare in the United States operated in the realm of Customized Care. That report helped us to develop programs for the provision of Safe Care and the patient safety movement began.

With regards to the prevention of RSI, safe care requires the existence of OR policies, which we think should be multi-stakeholder policies that guide behavior of all perioperative care personnel not just count policies directing nursing and hospital staff. A MultiStakeholder Prevention of Retained Surgical Items Policy has been newly revised and is available here.

Here is a video on the Sponge ACCOUNTing System to see how it works
http://www.hospitalcouncil.net/post/surgical-safety-preventing-retained-surgical-items

Standardized Care requires the presence of a standardized process, applicable to all ORs, L&D areas, cardiology suites - any place where surgical sponges are used and an incision is made, which are the minimal requirements for retention. We illustrate two standardized retained sponge prevention practices; the manual Sponge ACCOUNTing system and the electronic Computer Assisted Sponge Counting System. In the event of an incorrect count both of these systems would require the use of xrays to find a missing sponge.

In the domain of Customized Care we have positioned radiofrequency technology as a detection and accounting methodology primarily because of its newness and expense. The RF Detection System can be used with Sponge ACCOUNTing as the accounting methodology if the RF tagged sponges are used throughout the OR. The RFID Sponge Systems are a complete counting and detection practice. In the setting of an incorrect count both use wands to detect missing sponges and can serve as substitutes for xray which might minimize the need for OR personnel and patient exposure to x-irradiation .

Many hospitals have been able to accomplish the goal of having zero retained sponges for at least a year. The time has come where there is no excuse for retained surgical sponge cases to occur. There are a sufficient number of good systems in place to prevent this event from occurring and now it requires the necessary behavior changes to employ safer practices.

This educational site is intended for the use of healthcare organizations to prevent RSI. NoThing Left Behind® was started in October 2004 to work with multiple healthcare stakeholders to make sure RSI become a true “never ” event. The goal is to develop and disseminate evidence and experience-based best practices derived from clinical event analysis and the consensus effort of groups of perioperative personnel. All materials will be posted here as they become available. If you have questions or comments please contact:
drgibbs@nothingleftbehind.org