September 13, 2023

Analysis, education and technology combine elegantly to create a culture change at Emory Saint Joseph’s Hospital.

MESSY SITUATION By using technology to track surgical items and ensure they aren’t still inside the patient, OR teams can avoid scenarios that require rooting through the trash for missing sponges and other objects.

The Pennsylvania Patient Safety Authority estimates that the average cost related to a single retained surgical item (RSI) event is about $166,000, including costs associated with legal defense and payouts. Thankfully, many facilities are incurring much less of those costs by combining technological solutions with meticulous manual counts and standardized policies. In the process, the way surgical objects are counted before and after surgery is changing for the better.

Take Emory Saint Joseph’s Hospital in Sandy Springs, Ga., where CVOR Unit Nurse Educator Taccoa Harris, DNP, RN, CNOR, along with help from a few OR resident nurses, created an initiative that sought to bring more attention to RSIs throughout the health system while effectively reducing incidences of them. "I began to see a lot of inconsistencies," recalls Dr. Harris.

She and the staff focused on combining awareness, education and the use of RFID technology. By getting everyone on the same page first, the antiquated practice of using counting sheets was eliminated in favor of a newer, more accurate system. "We found very simple errors," says Dr. Harris of the sheets, including missing information and illegible handwriting. Now, staff simply waves a handheld device over each item. The device automatically counts and provides final documentation for all items used in the OR during surgery.

Dr. Harris implemented the new system in stages. First, she surveyed staff to measure their level of confidence in performing surgical counts. Next, she created incident reports to better assess the frequency of incorrect counts. Both the staff feedback and a review of the incident reports made it clear to her that a system overhaul was necessary.

Now, every new staff member must complete an annual competency on how to use the RFID technology, including a video and a quiz. "We set a standard for uniformity," says Dr. Harris. "Because we aren’t having these discrepancies, we’re able to focus more time on our patients while providing for the surgeons and the surgical team."

Forward-thinking facilities are looking for new ways to improve patient safety and prevent avoidable RSIs beyond the traditional methods.

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ORLocate^™ Surgical Counting and Detection System ^™

Patient safety is paramount in the outpatient surgery community and OR teams and their support staff work hard to ensure that each patient’s surgical journey is safe and efficient. Retained surgical items (RSIs), also referred to as retained foreign bodies or retained foreign objects (RFOs), are any instruments, tools, devices or surgical gauze unintentionally left in the body cavity at the completion of a surgery. It carries a risk to the patient, causes unexplained pain, nonhealing wounds and abscesses as well as signs of blockage – and clearly, should be avoided at all costs.

While there are processes in place to ensure that items used in surgery are accounted for – including the traditional manual counts – ambulatory surgery teams know there is more that can be done to prevent RSI. Often it is human interactions, leadership and communication that are root causes of these occurrences. The opportunity for RSIs exists even when a procedure involves very small incisions and is not exclusive to higher risk procedures.¹

An innovative surgical counting and detection system offers a solution that can curb incidents of retained objects. The range of items is surprisingly wide and can include forceps, tips for foley catheter insertion, drill tips and other device fragments as well as surgical gauze and sponges. However, the most common RSIs are "gossypiboma," the surgical sponge or a laparotomy pad left involuntarily in the body after a procedure. In fact, retained surgical sponges account for 48% to 69% of RSIs, according to the ECRI Institute.²

RSI cases are avoidable and can be prevented with the assistance of technology. New technologies that supplement manual counts have been found to be effective when used correctly, and healthcare professionals are encouraged to adopt these innovations. In fact, radio frequency identification (RFID) tracking has benefits over other technologies because it can count, locate and identify surgical items using unique serial numbers. Barcode-based systems simply count the items and RF-based systems can only locate them.

A radio frequency identification system is typically comprised of specialized tags that enable unique identification of individual surgical items, movable workstation, handheld reader, locator wand that can detect tagged items, and management software that connects with other business intelligence applications.

This allows for integration with OR and sterile processing workflows and real-time feedback for improved department efficiency. The primary benefit of using RFID technology for tracking RSIs is higher accuracy of detection, eliminating false positives and false negatives. This technology can help save time and human effort used during counting protocols and has the potential to substantially improve patient safety by reducing RSI errors.³

The ORLocate Surgical Counting and Detection System is one of these such technologies available today. Within seconds, ORLocateTM has the ability to count multiple surgical items before, during and after procedure. It also enables the user to detect items within the patient cavity as well as other locations in the OR – for example, waste bins and kick buckets – protecting against missed counts and reducing near misses.

Preventing RSIs requires a comprehensive team approach that involves the entire staff, the use of technology along with education and training. The Association of periOperative Registered Nurses (AORN) published updated Guidelines for Prevention of Unintentionally Retained Surgical Items recommending the use of adjunct technology during manual counting to prevent RSIs.1 It’s a team effort to avoid unnecessary pain for the patient and a clean track record for facilities as they serve their communities and provide a safe surgical journey for their patients.

References:

1. Association of periOperative Registered Nurses. Guideline for Prevention of Retained Surgical Items. In: Guidelines for Perioperative Practice. https://aornguidelines.org/guidelines?bookid=2260. Denver, CO: AORN; Revised: December 2021.

2. ECRI Institute. 2019 Top 10 Health Technology Hazards: Executive Brief. https://www.ecri.org/Resources/Whitepapers_and_reports/Haz_19.pdf. Published 2018.

3. Schnock KO, Biggs B, Fladger A, Bates DW, Rozenblum R. Evaluating the impact of radio frequency identification retained surgical instruments tracking on patient safety. https://pubmed.ncbi.nlm.nih.gov/28230583. Literature review. J Patient Saf. 2017.

Note: For more information go to ORLocate Surgical Counting and Detection System | STERIS and What are Retained Surgical Items? | Knowledge Center (steris.com)

With these four steps that combined standardized manual processes with adjunct technology, Mayo Clinic Rochester Hospital virtually eliminated the issue.

Before Mayo Clinic Rochester (Minn.) Hospital revamped its retained surgical item (RSI) policy, a retained sponge was reported there approximately once every 63 days. In the 18 months following the introduction of a barcode-scanning system to supplement manual counts, nearly two million sponges were counted without a single RSI.

How did Mayo Clinic do it? It implemented the following four-phase approach to establish uniformity across all of its ORs in terms of how items were counted.

Phase one: It performed a defect analysis in conjunction with a policy review. This process pinpointed both true and near misses, enabling the hospital to better understand and identify patterns of failure within its OR culture.

Phase two: It reviewed all relevant institutional policies, which resulted in changes designed to increase clarity and consistency about the issue across the entire hospital system.

Phase three: It increased awareness and communications about the issue with all personnel, including surgeons, residents, nursing and allied health staff. The educational process included specific programs about the causes and effects of RSIs, as well as staff conferences, team training, simulation videos and daily reminders with ongoing audits.

Phase four: During the monitoring and control phase, it prioritized all potential risks, with the goal of taking corrective action before any incidents occurred.

While every aspect of the RSI prevention overhaul was important, Robert R. Cima, MD, medical director at Mayo Clinic, says a critical component of its overall success was the addition of a data-matrix-coded sponge counting system. "The benefit of the barcode system is that it brings a structure," he says. "You need to have the structure in order to the support the teams. The technology has helped to take the guesswork out of the counting process by placing the onus on smart accounting rather than any one person."

As helpful as adjunct technology such as a barcode-scanning or RFID systems can be in helping facilities reduce incidences of RSIs, it’s essential for leaders to understand that these systems should complement manual processes, not replace them. "It’s a tool," says Dr. Cima. "If you don’t do the hard work up front to improve the culture and communication, adding the tech is simply not going to be the solution."

One large multistate organization has made significant progress but isn’t stopping there.

Ascension, a multicenter healthcare organization that operates 114 facilities across 12 states, experienced harmful events due to retained surgical items (RSIs) every eight days from 2019 to 2020. In response, it established a research team whose mission was to reduce incidences of harm due to RSIs, improve near-miss reporting and increase process reliability in Ascension’s ORs.

All Ascension facilities were invited to participate in the team’s patient safety initiative. A multidisciplinary workgroup then worked on developing and implementing an evidence-based best practice bundle with five elements:

Surgical stop. Prior to the first stitch of closure, the surgeon announces, “It is time for our surgical stop.” All activity pauses while the surgeon explores the wound. When finished, the surgeon announces, “Wound explored.” If the surgeon does not initiate the stop, other team members are empowered to say, “I would like to perform our surgical stop before proceeding with closure.”

Surgical debrief. This occurs prior to the surgeon leaving the OR. All team members halt activities and participate in the debrief. A nurse verifies all counts and resolves incorrect counts. The surgeon details the procedure, wound class, estimated blood loss, specimens labeling and medications administered. The team discusses what went well, what can be better, and describes the patient disposition (catheter/tubes/drains), additional concerns and family location.

Visual counter. On a whiteboard, surgical items including sponges, laps, gauze, needles and instruments are tracked throughout the procedure. Patient identifiers and procedure details are also noted.

Imaging. At the surgeon’s discretion, X-ray or computed tomography are used prior to the first stitch of closure when the soft surgical count or large needle count is incorrect and cannot be resolved to validate that no items are retained in the patient.

Reporting of deviations. Incorrect surgical counts without resolution and other irregularities are recorded in an event reporting system.

Additionally, counter bags are recommended for use during the count for easier visualization of sponges and to assist with the counting.

Extensive education and support were accessible to all participating sites. The researchers monitored the process reliability of the bundle elements, the improvement milestones of all sites and, of course, the rates of harm related to RSIs.

The team published its findings and impressive results this year in The Joint Commission Journal on Quality and Patient Safety. After implementing the bundle across all 114 facilities, Ascension realized a 14.3% reduction in the rate of harm caused by RSIs and a 59.1% increase in RSI near-miss reporting. Compliance with the bundle averaged 70.5%, and 63.2% of the facilities now actively perform Plan-Do-Check-Act (PDCA) cycles to improve compliance.

The researchers note that while much research has focused on rollouts of RSI prevention bundles at individual sites of care, they sought to fill a research void on the subject in terms of multifacility organizations spread across multiple states. Although the results were promising, they believe more study and effort is required to further improve consistency of compliance at Ascension facilities. OSM