By Kelly M. Pyrek
Infection prevention and surgical services departments share a united concern about retained surgical items, a healthcare threat that was No. 8 on the ECRI Institute's 2016 Top 10 Patient Safety Concerns list.
"With unintentionally retained objects, the problem is the enormous amount of harm that can result,” such as perforation, infection, pain, damage to other body parts, and death," says Gail Horvath, MSN, RN, CNOR, CRCST, a patient safety analyst at ECRI Institute. Counting surgical items is an important preventive measure; however, “counting is a human process that’s very prone to error, especially in a busy environment where multiple things are happening simultaneously,” Horvath adds. The ECRI Institute (2016) emphasizes that "Organizations need to ensure that a good evidence-based process for preventing retained objects is in place and that staff can follow it. A culture that creates team account-ability and empowers nurses to speak up is a central component. Because counting is so error-prone, a systems and human factors approach can aid process evaluation and improvement."
A retained surgical instrument is considered to be any item inadvertently left behind in a patient's body in the course of surgery. A Sentinel Event Alert from the Joint Commission in 2013 warned clinicians about the dangers of unintended retention of foreign objects (URFOs) – also called retained surgical items (RSIs) – after invasive procedures. Depending on the type of object retained and the length of time it is retained, these RSIs can cause infections and death, and surviving patients may sustain both physical and emotional harm.
Retained foreign objects are most commonly detected immediately post-procedure; by X-ray; during routine follow-up visits; or from the patient’s report of pain or discomfort. According to the Association of periOperative Registered Nurses (AORN), RSIs most commonly left behind after a procedure are:
- Soft goods, such as sponges and towels
- Small miscellaneous items, including unretrieved device components or fragments (such as broken parts of instruments), stapler components, parts of laparoscopic trocars, guidewires, catheters, and pieces of drains
- Needles and other sharp implements
- Instruments, most commonly malleable retractors
The Pennsylvania Patient Safety Authority (2009) estimated that the average total cost of care related to an URFO is about $166,000, which includes costs associated with legal defense, indemnity payments, and surgical costs not reimbursed by the Centers for Medicare & Medicaid Services. A study by Regenbogen, et al. (2009) estimated medical and liability costs to be $200,000 or more per incident.
From 2005 to 2012, 772 incidents of URFOs were reported to the Joint Commission’s Sentinel Event database, including 16 deaths resulting from these incidents. In hospital settings, these incidents occurred in operating rooms, labor and delivery areas, as well as ambulatory surgery centers and other areas where invasive procedures are performed. According to the sentinel event data, the most common root causes of URFOs reported to the Joint Commission are the absence of policies and procedures; failure to comply with existing policies and procedures; problems with hierarchy and intimidation; failure in communication with physicians; failure of staff to communicate relevant patient information; and inadequate or incomplete education of staff.
The medical literature indicates that the most common risk factors for URFOs include patients with high body mass index, an emergent or urgent procedure, and unanticipated/unexpected change during the procedure. Other risk factors include intra-abdominal surgery; more than one surgical procedure; involvement of multiple surgical teams; multiple staff turnovers during the procedure; and unexpected intraoperative development. Occurrence of an URFO was nine times as likely when an operation was performed on an emergency basis and four times as likely when the procedure changed unexpectedly.
The Joint Commission explains that cavity sweeps and manual counting protocols have been used by perioperative personnel to prevent retained surgical items and sponges; however, it emphasizes that current practices for counting sponges have a 10 to 15 percent error rate. In addition, 80 percent of retained sponges occur with what staff believe is a correct count. Sentinel event data show an incorrect or “discrepant” count in 52 of the 772 URFO sentinel events reported to the Joint Commission. Improvements to counting procedures are the most obvious solution to the problem, and the Joint Commission urges surgical team members to embrace standardized practices, meaning to develop and sustain reliable counting practices that ensure all surgical items are accounted for and recorded.
Compliance with evidence-based practices found in guidelines and recommendations is essential. However, as with many aspects of infection prevention and control and aseptic technique, adoption of these practices can be variable. "The most challenging aspect of compliance with the AORN Guideline for Prevention of Retained Surgical Items is achieving consistency in clinical practice, especially in an emergency situation or deviation from the expected," says Amber Wood, MSN, RN, CNOR, CIC, FAPIC, senior perioperative practice specialist at AORN. "Human factors are a constant challenge in implementing consistent practice for preventing retained surgical items, especially when a safety variance occurs. Team training programs, established count and discrepancy reconciliation policies, and a proactive systems approach to quality improvement may all bolster efforts to prevent retained surgical items and minimize the effect of human factors."
When it comes to gaps in knowledge among perioperative nurses about preventing retained surgical items, Wood says, "One gap in knowledge is fixating on detailed counting procedures, such as the timing of counting or counting by one versus multiples, and failing to see the larger picture of accountability and the importance of consistency. An outside perspective on the overall vision of being accountable for surgical items placed in the patient’s wound would be valuable in reminding the team of the purpose for counting procedures."
Compliance with guidelines can be boosted with the participation of the infection preventionist, Wood says. "The infection preventionist has a focused mission in preventing surgical site infection as an outcome of a retained surgical item. Researchers have proven that retained surgical sponges can migrate from the abdomen or pelvis to the intestine, bladder, thorax, or stomach. This process, called transmural sponge migration, is fraught with risk for infection development via abscess or fistula formation. In this regard, the infection preventionist has the opportunity to educate perioperative team members on the risk of infection to the patient from a retained surgical item. Infection preventionists can also sup-port perioperative leaders in creating a culture of safety by advocating for team training, systems thinking, human factors analysis, and proactive risk assessments."
The AORN Guideline for Prevention of Retained Surgical Items recommends the following:
1. A consistent multidisciplinary approach should be used for preventing RSIs during all surgical and invasive procedures. As the guideline ex-plains, "Establishing a system that accounts for all surgical items opened and used during a procedure constitutes a primary and proactive strategy to prevent patient harm… The ideal RSI prevention measures are standardized, transparent, verifiable and reliable. Deliberate, consistent application of and adherence to standardized procedures are necessary to prevent the retention of surgical items."
2. Surgical soft goods opened onto the sterile field should be accounted for during all procedures in which soft goods are used.
3. Sharps and other miscellaneous items that are opened onto the sterile field should be accounted for during all procedures in which sharps and miscellaneous items are used.
4. Instruments should be accounted for in all procedures for which the likelihood exists that an instrument could be retained.
5. Measures should be taken to prevention of device fragments.
6. Standardized measures for reconciling count discrepancies should be taken during the closing count and before the end of surgery. When a discrepancy in a count is identified, the surgical team should take actions to locate the missing item.
7. A multidisciplinary team may evaluate adjunct technologies for use as a supplement to manual counting procedures at the healthcare organization.
8. Documentation should reflect activities related to prevention of RSIs.
9. Policies and procedures for the prevention of RSIs should be developed, reviewed periodically, revised as necessary, and readily available in the practice setting.
10. Perioperative personnel should participate in a variety of quality assurance and performance improvement activities that are consistent with the facility or healthcare organization plan to improve understanding and compliance with the principles and processes of RSI prevention.
The Joint Commission recommends that hospitals employ improved multi-stakeholder perioperative processes, enhanced team communication, and the use of assistive technology to prevent URFOs, and provides the following action steps:
1. Create a highly reliable and standardized counting system to prevent URFOs – making sure all surgical items are identified and accounted for. The counting system should be supported by organizational leaders, and developed using a multidisciplinary approach, involving surgeons, proceduralists, nurses, surgical technologists, anesthesiologists, radiologists, and radiology technologists working together as a team in an environment that promotes the exchange of knowledge and information.
2. Develop and implement effective evidence-based organization-wide standardized policy and procedures for the prevention of URFOs through a collaborative process promoting consistency in practice to achieve zero defects. Use resources published by The Joint Commission, World Health Organization, American College of Surgeons, AORN, No Thing Left Behind, and other organizations and publications as a guide. The policy should apply to all operative and other invasive procedures, and should address the following.
A counting procedure should:
- Be performed audibly and visibly by two persons engaged in the process, usually scrub tech or scrub nurse and circulating registered nurse. The surgical team should verbally acknowledge verification of the count.
- Include counts of items added to the surgical field throughout the surgery or procedure.
- Include counts of soft goods, needles/sharps, instruments, and small miscellaneous items, and document unretrieved device fragments.
- Verify that counts printed on prepackaged sponges and instrument sets are correct. Handle the discrepancy per the organization’s policy.
- Be performed before the procedure begins, in order to establish a baseline count; before the closure of a cavity within a cavity; before wound closure begins; at skin closure or end of procedure; and at the time of permanent relief of either the scrub person or the circulating registered nurse.18
- Be applicable in all settings where invasive procedures are performed.
- Be reviewed periodically and revised as appropriate.
The Joint Commission emphasizes that team briefings should be a standard part of the surgical procedure to allow the opportunity for any team member to express concerns they have regarding the safety of the patient, including the potential for an URFO. This will promote open communication among surgical team members.
It is also advised that perioperative personnel document the results of counts of surgical items, instruments, or items intentionally left inside a patient (such as needle or device fragments deemed safer to remain than remove), and actions taken if count discrepancies occur. As the Joint Commission notes, "Tracking discrepant counts is important to understanding practical problems; tracking reports and data also can be dis-cussed at improvement meetings. Collecting, analyzing and sharing accurate data is key to understanding your organization’s frequency or risk of URFOs, identifying the types of URFOs that occur most frequently, and determining how to address certain kinds of URFOs."
Association of periOperative Registered Nurses (AORN). AORN Guideline for Prevention of Retained Surgical Items. 2017.
Joint Commission. Sentinel Alert: Preventing unintended retained foreign objects. Issue 51, Oct. 17, 2013.
Pennsylvania Patient Safety Authority. Beyond the count: preventing retention of foreign objects. Pennsylvania Patient Safety Advisory, June 2009;6(2):39-45, http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Jun6(2)/Pages/39.aspx
Regenbogen, et al: Prevention of retained surgical sponges: A decision-analytic model predicting relative cost-effectiveness. Surgery, 2009;145:527-35.