R E V I E W S & A N A LY S E S Retained Surgical Items: Events and Guidelines Revisited Susan C. Wallace, MPH, CPHRM INTRODUCTION Patient Safety Analyst Pennsylvania Patient Safety Authority Retained surgical items (RSIs)*—also known as unintended retained foreign objects or retained foreign bodies—can cause emotional and severe physical harm such as infection, loss of function, and even death.1 Nationally, items left behind include sponges, sharps ABSTRACT and needles, instruments, small miscellaneous items, devices, and device fragments.2 Surgical items such as sponges, sharps, Patients may suffer for years with pain or other disabilities as a result of an undiag- and instruments may be retained dur- nosed RSI. For example, a sponge was found in a California woman four years after ing surgery and can lead to serious abdominal surgery. She complained of nausea, dehydration, and bleeding before the patient harm. Ongoing analysis of sponge was discovered during surgery for a suspected ovarian cyst.3 reports to the Pennsylvania Patient RSIs are considered a serious reportable event by the National Quality Forum4 (NQF) Safety Authority suggests retained surgi- and a sentinel event by the Joint Commission.5 The organizations differ on criteria for cal items (RSIs) remain a challenge to the conclusion of surgery (see “Retained Surgical Item Definitions”). The Pennsylvania Pennsylvania hospitals. Analysis of data Patient Safety Authority does not endorse a particular RSI definition. from 2014 through 2015 revealed 112 RSIs that met the definitions of both the NQF endorses RSIs as one of 29 events suitable for public reporting so that organiza- National Quality Forum and the Joint tions can take actions to prevent recurrence and deliver safer healthcare. The Joint Commission, and an additional 16 that Commission reports that organizations continue to struggle with RSIs, which were the met the Joint Commission definition most frequently reported sentinel event in 2014 and 2015, with 112 and 115 reported, alone, for a total of 128 RSIs. Analysts respectively.6 The Centers for Medicare and Medicaid Services (CMS) includes RSIs as found surgical sponges were the most hospital-acquired conditions that should never happen.7 commonly retained item, followed by Articles published about RSIs in the Pennsylvania Patient Safety Advisory in 20098 and small miscellaneous items such as 20129 offer recommended best practices and guidance for preventing RSIs. Ongoing screws. Most RSIs were left behind in analysis of reports to the Authority suggests RSIs remain a challenge. the abdomen and pelvis, followed by the vagina and chest. Analysts estimate METHODS that 1 to 2 RSIs occur per 100,000 patient procedures. Device fragments, Analysts queried the Pennsylvania Patient Safety Reporting System (PA-PSRS) database such as broken drill bits or needle tips, for reports of events that were discovered (date item was recognized) between January could not be retrieved in 57 additional 2014 through December 2015 (inclusive) using search terms including “foreign,” “fb,” surgical cases. Since publication of the “retained,” “detected,” “retrieve,” “discover,” “missing,” “search,” “fragment, “tip,” and June 2012 Pennsylvania Patient Safety “wrong count” regardless of care area (e.g., delivery suite, catheterization laboratory, Advisory, both the Joint Commission operating room [OR]). The search term “RSI” yielded 19 cases: 8 were duplicates found and the Association of periOperative through other search methods, 9 had the string “RSI” within other irrelevant reports Registered Nurses published guidance (e.g., rapid sequence intubation), and 2 reported unsuccessful searches for possible for preventing RSIs, including minimizing foreign bodies. Events were excluded if the event narrative contained phrases such distractions and participating in team- as “absence of foreign,” “x-ray found no,” “no evidence of foreign,” “no evidence of work training. The Joint Commission retained,” or “did not identify foreign.” Event reports identified via relevant monitor speaks to the role of weak or absent codes assigned by analysts to classify events were also included in the dataset. organizational leadership as reasons for Analysts manually reviewed the resulting set of event report narratives to identify the continuance of RSIs. (Pa Patient Saf reports describing RSI events and grouped them into related categories by harm score, Advis 2017 Mar;14[1]:27-35.) anatomic site, event type categories, event reporting taxonomy, and by NQF and Joint Commission definitions. Retained and unretrieved objects that were unrecognized† at the time they were left behind were classified into the following related categories using a taxonomy * For the purposes of this article, the term retained surgical item or RSI will be used for any item or foreign object retained after a procedure, including surgery or vaginal delivery, and other health- care procedures (e.g., dressing application), regardless of when the object was discovered. † For the purposes of this article, “unrecognized” implies the device fragment was unknowingly left behind. Vol. 14, No. 1—March 2017 Pennsylvania Patient Safety Advisory Page 27 ©2017 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S RETAINED SURGICAL ITEM DEFINITIONS National Quality Forum* The National Quality Forum defines retained surgical item as unintended retention of a foreign object in a patient after surgery or other invasive procedure. This includes medical or surgical items intentionally placed by providers that are unintentionally left in place. It excludes (1) objects present prior to surgery or other invasive procedure that are intentionally left in place, (2) objects inten- tionally implanted as part of a planned intervention, and (3) objects not present prior to surgery or a procedure that are intentionally left in when the risk of removal exceeds the risk of retention such as microneedles and broken screws.1 This event is intended to capture: ——  Occurrences of unintended retention of objects at any point after the surgery or procedure ends, regardless of setting (post-anes- thesia recovery unit, surgical suite, emergency department, patient bedside) and regardless of whether the object is to be removed after discovery. ——  Unintentionally retained objects (including such things as wound packing material, sponges, catheter tips, trocars, guide wires) in all applicable settings.1 Surgery ends after devices such as all probes and instruments have been removed; if relevant, final surgical counts confirming accu- racy of counts and resolving any discrepancies have concluded; all incisions or procedural access routes have been closed in their entirety; and the patient has been taken from the operating or procedure room.2 The Joint Commission† The Joint Commission considers unintended retention of a foreign object in a patient after an invasive procedure a sentinel event.3 If a foreign object (e.g., a needle tip or screw) is left in the patient because of a clinical determination that the relative risk to the patient of searching for and removing the object exceeds the benefit of removal, this would not be considered a sentinel event to be reviewed. However, in such cases, the organization shall (1) disclose to the patient the unintended retention, and (2) keep a record of the retentions to identify trends and patterns (e.g., by type of procedure, by type of retained item, by manufacturer, by practitioner) that may identify opportunities for improvement.3 When, exactly, is “after surgery”?4 “After surgery” is any time after completion of the skin closure, even if the patient is still in the operating room under anesthesia. adapted from NoThing Left Behind®2, —— Other items: the risk of removal exceeded the risk of AORN9, and the U.S. Food and Drug * Other soft goods (e.g., cotton retention (e.g., broken screws, piece of a Administration (FDA):10 ball, dressings placed outside of drill bit) were categorized separately. Items —— Items traditionally counted in the OR) (e.g., sponges) that were intentionally OR: * Unknown item (i.e., items not placed and left in place either temporarily identified in the event narrative) or permanently were excluded. * Soft goods (e.g., surgical sponges, surgical towels, dressing * Devices (e.g., guidewires or An approximate RSI statewide rate was sponges, drape towels, packs, catheters left in intravascular or calculated by dividing the total number prep swabs, gauzes) interstitial spaces) of RSIs identified during procedures * Sharps (e.g., scalpel blades, * Unretrieved unrecognized device performed in OR suites in hospitals and suture needles) fragments (device fragments that ambulatory surgical facilities (excluding are not retrieved because they vaginal RSIs) divided by the total number * Instruments (e.g., the whole are unrecognized (i.e., broken of OR revenue codes (excluding labor instrument such as forceps, scis- parts or pieces of devices and room/delivery revenue codes) identified sors, retractors) surgical items) from statewide inpatient and outpa- * Small miscellaneous items (e.g., tient hospitals and ambulatory surgery small intact items such as a wing Unretrieved device fragments that were facilities. nut, vessel loops, screws, nails) recognized but were left behind when Page 28 Pennsylvania Patient Safety Advisory Vol. 14, No. 1—March 2017 ©2017 Pennsylvania Patient Safety Authority RETAINED SURGICAL ITEM DEFINITIONS (continued) Why was this particular point in the process selected as the definition of “after surgery”? The decision to define “after surgery” as the completion of skin closure was based on the premise that a failure to identify and correct an unintended retention of a foreign object prior to that point in the procedure represents a significant system failure, which requires analysis and redesign. It also places the patient at additional risk by virtue of extending the surgical procedure and time under anesthesia. Sometimes a needle or screw will break, leaving a fragment behind. Is this a reviewable sentinel event? In some cases, a broken needle or screw fragment is recognized at the time of surgery and a clinical judgment is made to leave the fragment in the patient. That decision is based on an assessment of the relative risks of leaving it in versus removing it. Therefore, it would not be considered an unintentionally retained foreign object. What about a retained sponge following vaginal delivery? A retained sponge after a vaginal delivery is a reviewable sentinel event. The new language in the definition of reviewable sentinel events is, “Unintended retention of a foreign object in a patient after surgery or other procedure.” Note that it says “other procedure” not “other invasive procedure.” Vaginal delivery in the hospital is not an “invasive” procedure, but it is a procedure. More to the point, a retained sponge in this circumstance is indicative of the same underlying systemic problems that could cause other “retained foreign body” situations. * © National Quality Forum Aug 8, 2016. Reprinted with permission. † ©The Joint Commission, 2016. Reprinted with permission. Notes 1. Serious reportable events in healthcare - 2011 update: a consensus report. Washington (DC): National Quality Forum; 2011. Appendix A. p. A4. Also available: https://www.qualityforum.org/Publications/2011/12/SRE_2011_Final_Report.aspx. 2. Serious reportable events in healthcare - 2011 update: a consensus report. Washington (DC): National Quality Forum; 2011. Appendix B. p. B4. Also available: https://www.qualityforum.org/Publications/2011/12/SRE_2011_Final_Report.aspx. 3. Sentinel event policies and procedures. [internet]. The Joint Commission; 2016 Oct 14 [accessed 2016 Jul 01]. [2 p]. Available: https://www. jointcommission.org/sentinel_event_policy_and_procedures/. 4. Frequently Asked Questions: retained foreign object after surgery. [internet]. The Joint Commission; 2007 Apr 27 [accessed 2016 Jul 01]. [1 p]. Available: https://www.jointcommission.org/assets/1/18/retained_foreign_objects_faqs.pdf. OR revenue codes used are as follows: Health Care Cost Containment Council Analysts conducted a review of the litera- —— 0360: OR Services (PHC4);* and was compared to the num- ture to identify strategies to reduce RSIs ber of RSIs from the same time period.† and patient harm in healthcare facilities. —— 0361: OR/Minor For rate calculation purposes, analysts Interviews with representatives of the —— 0362: OR/Organ Trans considered the number of revenue codes Joint Commission and the Association —— 0367: OR/Kidney Trans to be a proxy for the number of proce- of periOperative Registered Nurses —— 0369: OR/Other dures performed. (AORN) were also conducted to identify Revenue code data was provided for † 2014 through 2015 by the Pennsylvania Caution should be taken when interpreting results for the number of procedures performed in an operating room that is based on counting the number of operating room revenue codes. The inpatient report may under-represent the number of surgical procedures performed in an * The Pennsylvania Health Care Cost Contain- operating room, and the outpatient report may over-represent the number of surgical procedures ment Council (PHC4) is an independent state performed. PHC4 data captures procedures that are performed per patient claim record. Also agency responsible for addressing the problem included on the claim record, when applicable, are operating room revenue codes. The report was of escalating health costs, ensuring the quality produced using operating room revenue codes within a claim record to capture and count the of health care, and increasing access to health number of operating room revenue codes per claim record. One inpatient claim record may have care for all citizens. While PHC4 has provided one or more operating room revenue codes associated with one or more procedures performed data for this study, PHC4 specifically disclaims on the same day. One outpatient claim record may have one or more operating room revenue responsibility for any analyses, interpretations, codes with associated procedures performed on the same day, but may also have other performed or conclusions. procedures associated with other revenue codes. Vol. 14, No. 1—March 2017 Pennsylvania Patient Safety Advisory Page 29 ©2017 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S Figure 1. Retained Surgical Item Flow Chart fragment) that were recognized but were intentionally not retrieved by the surgeon. Query of PA-PSRS database Occurrence. Excluding vaginal RSIs, ana- using search terms related to lysts identified 82 (NQF criteria) and 97 retained surgical items; items (Joint Commission criteria) RSI reports discovered January 1, 2014, that were discovered during the same time through December 31, 2015: period that 5,493,283 OR revenue codes N = 1,145 were submitted. Analysts estimate that 1.5 (NQF criteria) and 1.8 (Joint Commission criteria) RSIs occur per 100,000 patient Narratives reviewed: procedures. N = 1,145 RSI Events Analysts grouped RSI events into the fol- Retained surgical items: Known but unretrieved Reports excluded lowing case scenarios with examples of n = 112 by NQF criteria device fragments: because irrelevant events reported to the Authority:* n = 128 by Joint n = 57 (e.g.,“no evidence of FB”) Commission criteria or FB was intentional 1. Surgical count correct; RSI found (e.g., sponges placed as after surgery: temporary packing): MS16831 Patient underwent a right radical n = 960 nephrectomy, with a robotic-assisted and hand-assisted port. All counts FB, Foreign body; NQF, National Quality Forum; PA-PSRS, Pennsylvania Patient Safety Reporting were correct. A few days later, the System. patient developed a fever and vomit- ing. An X-ray revealed a retained best practices and resources developed for b. Joint Commission: 4 (of 128, surgical sponge. The patient was reduction of RSI events. 3.1%) taken back to the operating room for sponge removal. All events were associated with hospitals RESULTS and ambulatory surgical facilities (i.e., no 2. Incision re-opened after incorrect Analysts identified 112 RSIs that met events were identified from birthing or sponge or instrument count: both NQF and Joint Commission abortion centers). Patient went to surgery for several pro- definitions (see “Retained Surgical Item Events were categorized by harm scores cedures. After [the patient’s incision] Definitions”), and an additional 16 that was closed, the sponge count was found with 53.6% (60 of 112) reported as met Joint Commission definition alone, to be incorrect. First count of sponges Serious Events according to NQF, and for a total of 128 RSIs. was relayed as correct, second count was 53.9% (69 of 128) according to the Joint wrong. Patient was still under anesthesia The identified events were submitted in Commission. See Table for harm scores. and draped. Patient was reopened, the three PA-PSRS event type categories: Taxonomy. Analysts categorized counted sponge removed and [incision] re-closed. 1. “Error related to procedure/ soft goods as the predominant RSI item 3. Surgical count correct; missing treatment/test” reported by Pennsylvania healthcare facili- sponge identified by surgical count- a. NQF: 90 (of 112, 80.4%) ties, using NQF (47/112, 42.0%) and Joint ing device: Commission (58/128, 45.3%) criteria. b. Joint Commission: 103 (of 128, Initial and subsequent visual counts veri- 80.5%) Body site. Most RSIs were left in the abdo- fied by circulator and surgical technician. 2. “Complication of procedure/treat- men or pelvis, followed by the vagina, Physician informed counts were correct. ment test” chest, head, extremities, and soft tissue After close of skin, surgical counting space (see Figure 3). device identified a missing sponge at final a. NQF: 18 (of 112, 16.1%) count. X-ray confirmed a sponge on right b. Joint Commission: 21 (of 128, Unretrieved recognized device frag- 16.4%) ments. Analysts found an additional 57 event reports describing device fragments * The details of the PA-PSRS event narratives 3.“Other/miscellaneous” in this article have been modified to preserve (e.g., broken screw, catheter tip, metallic confidentiality. a. NQF: 4 (of 112, 3.6%) Page 30 Pennsylvania Patient Safety Advisory Vol. 14, No. 1—March 2017 ©2017 Pennsylvania Patient Safety Authority side of abdomen. Incision was reopened Patient taken to OR for exploratory Any time an item is retained, a critical and sponge was retrieved. laparotomy, which revealed a foreign investigation should be conducted to 4. RSI discovered during surgery for body that was removed. see where the process failed, according another procedure: to Wood. “It’s important that we rectify The following case scenarios are examples the mistake and also use it as a learning During patient’s surgical procedure, of an unretrieved recognized device opportunity to prevent it from happening the surgeon found part of a plastic fragment: in the future,” she said. drain in the patient’s abdomen. During an operative procedure to fix Ronald M. Wyatt, MD, MHA, patient Retained sponge found in patient’s a bone fracture, a drill bit broke and safety officer and medical director in the abdomen when patient’s chest was was intentionally left in place. Division of Healthcare Improvement opened for transplant surgery. When the physician’s assistant was at the Joint Commission said the Joint 5. Vaginal RSI discovered by another closing the patient’s wound, the tip of Commission receives sentinel events healthcare provider: a needle broke off. The surgeon was in which the patient never leaves the Patient had a spontaneous vaginal notified and returned to the room. A OR.12,13 “We don’t get into the location delivery and had a small tear requir- flat plate was ordered and showed a of the patient,” he said. “If that patient ing a single stitch. At the patient’s very small foreign object within the is in the operating room or out of the first post-partum visit, the nurse prac- leg. After attempting to retrieve the operating room, and the team knows titioner discovered a retained sponge. piece of metal unsuccessfully, the sur- there was something left behind and it wasn’t addressed, it is a URFO [unin- The patient underwent removal of geon decided to continue with wound tended retained foreign object].” The an ovarian cyst. A two-part uterine closure. The tip was approximately 2 commission uses the term “URFOs” manipulator was inserted vaginally millimeters. Surgeon felt retrieval of since there is a “spectrum” of items that for the procedure. Three weeks later, the needle tip would cause more harm can be left behind that are not all surgi- one part of the manipulator was than to leave the needle tip in place cal items, he said. Pennsylvania facilities found in the patient during a post-op in soft tissue. Surgeon notified patient can report these events through PA-PSRS visit and removed. and spouse. using the event type “Events related to Patient delivered vaginally with repair procedure/treatment/test,” and selecting of episiotomy. She was discharged DISCUSSION the subtypes “Surgery/invasive proce- to home. Four weeks later, she went RSI Reporting dure problem,” and “Foreign body in to the emergency department with patient.”14 There is controversy about the determi- complaints of vaginal pain. An exam- nation of when an item is “retained,” Safety culture. “By definition, these ination revealed a retained vaginal according to Amber Wood, MSN, RN, events may have led to death, permanent sponge. The sponge was removed and CNOR, CIC, CPN, senior periopera- harm, or severe temporary harm,” Wyatt the patient was discharged to home in tive nursing specialist at AORN,11 but said.12 When reviewing the causes that stable condition. both NQF and Joint Commission agree directly related to the event, the Joint 6. RSI discovered at another facility: that RSIs pose serious complications for Commission found limitations in leader- An x-ray from another facility patients. ship, communication, and teamwork as revealed a retained foreign object. the top three root causes, he said. Table. Retained Surgical Item Events Reported to the Pennsylvania Patient Safety Authority, by Event Harm* HARM (SCORE) NO. (%) OF EVENTS National Quality Forum Joint Commission Criteria Criteria (N = 112) (N = 128) Incident: Unsafe conditions (A) 3 (2.7%) 3 (2.3%) Incident: No harm (B1 through D) 48 (42.9%) 55 (43.0%) Serious Event: Temporary harm (E through F) 60 (53.6%) 69 (53.9%) Serious Event: Significant harm (G through I) 1 (0.9%) 1 (0.8%) Note: Data from January 2014 through December 2015. Events are as defined by the National Quality Forum and The Joint Commission. * Event harm scores are defined by Pennsylvania Patient Safety Reporting System taxonomy and are assigned to events by healthcare facilities at the time of report submission. http://www.patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2015/mar;12(1)/PublishingImages/taxonomy.pdf Vol. 14, No. 1—March 2017 Pennsylvania Patient Safety Advisory Page 31 ©2017 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S Figure 2. Retained Surgical Items as Reported to the Pennsylvania Patient Authority analysts also found the same Safety Authority three most common sites. Increased appreciation has occurred around the REPORTS problem of retained vaginal sponges and 70 miscellaneous items left behind after 58 spontaneous vaginal births as well as 60 Counted Other elective gynecological operative cases, 50 47 according to Gibbs. This has led to efforts to move better safety and prevention 40 strategies to labor and delivery areas in addition to the OR and other procedural 30 areas, she said. 21 20 18 13 13 Rate of occurrence. The rate of occurrence 11 11 10 10 varies in the literature and is difficult to 10 4 5 3 4 6 6 MS16621 compare because different RSI defini- 0 tions, information sources, and taxonomy are used. The overall frequency is esti- s m s ts ps Un me ized m es s od ite ou od en ite vic ar mated at 1 in 1,500 abdominal operations kn nts s e go go um g n Sh an De n fra g ow and 1 in every 8,000 to 18,000 inpatient e eco ft ft str ell So so In isc surgical procedures.15,16 Gibbs states on vic nr er lm de d u th her website that estimates range from O al e ev Sm 2,000 to 4,000 events each year in the tri re United States.2 Un National Quality Forum criteria The Joint Commission criteria Device Fragment Adverse Events Note: As Reported through the Pennsylvania Patient Safety Reporting system, January 2014 Device fragments are a concern because through December 2015; Analysis of data revealed 112 RSIS that met the definitions of both they can cause local tissue reaction, infec- the National Quality Forum (NQF) and the Joint Commission, and an additional 16 that met the Joint Commission definition alone, for a total of 128 RSIs. tion, perforation and obstruction of blood vessels, and death.10,17 Contributing or mitigating factors may include biocompat- “Typically, what underscores all of those NoThing Left Behind ibility of the device materials, location of root causes is a failed safety culture,” Verna C. Gibbs, MD, clinical professor the fragment, potential migration of the Wyatt said. Teams that don’t work well of surgery, University of California, San fragment, and patient anatomy. During together because of some team dynamic Francisco, and director of NoThing Left magnetic resonance imaging (MRI) or dysfunction, will work around a Behind®, a national surgical patient procedures, magnetic fields may cause process or a person until it results in a safety project to prevent retained surgi- metallic fragments to migrate, and radio- sentinel event, Wyatt said. “What we typi- cal items, works with healthcare systems frequency fields may cause them to heat, cally find is weak or absent leadership,” in Minnesota and California to help causing internal tissue damage and/or he said. “We can put in all kinds of pro- standardize event reporting of RSIs and burns. In 2008, FDA published a Public cesses, but if leadership is not working on understand root causes.2 Using a struc- Health Notification describing serious building a strong culture of safety, we are tured taxonomy to classify RSIs, Gibbs adverse events arising from fragments of going to keep seeing events.” found the most frequently retained item is medical devices left behind after surgi- There are three victims: the patient, the the cotton gauze surgical sponge with most cal procedures.10 In contrast with FDA’s care teams, and the organization, Wyatt reports referring to a 4- by 4-inch sponge description, this Advisory article analysis said. “Folks in the community will not or the 18- by 18-inch laparotomy pad.2 differentiates whether the device fragment go there for surgery,” he said. “This is a was knowingly left behind (versus discov- Body sites. Gibbs found the most com- reputational issue for the organization. ered subsequently). Authority analysts mon body sites where RSIs are found are Culture should not tolerate this type of found 57 unretrieved recognized device the abdomen/pelvis, the vagina, and then behavior.” fragments known to the surgeon but left the chest, in that order.2 In Pennsylvania, Page 32 Pennsylvania Patient Safety Advisory Vol. 14, No. 1—March 2017 ©2017 Pennsylvania Patient Safety Authority Figure 3. Body Site of Retained decrease the risk of RSIs during all facets —— Assess individuals’ competency Surgical Items of an invasive procedure.6,18 A consistent in the count process prior to the counting method, separating items (e.g., completion of orientation and then sponges), minimizing distractions, and annually.18 Head Soft tissue Unknown team training are best practices, according 10 space —— View counts concurrently by two 5 to Wood.11 10 7 individuals including the nurse 7 7 “We found that when you’re standardiz- circulator.18 ing your counting, that you’re less likely to —— Consider using a sponge pocketing Chest make mistakes, and that is what the litera- system and pointing at the item 18 ture has showed us,” Wood said. “That while audibly counting.18 18 is part of human factors and how human beings think.” AORN also recommends Minimize Distractions, Noise, Abdomen not subtracting or removing items from and Interruptions18 33 44 the count. “The more you are manipulat- —— Minimize distractions, noise, and ing the count, the more risk you have for unnecessary interruptions during Vagina making a calculation error,” Wood said. the surgical count. This can include 30 Team members may be helped by tools limiting the number of individuals 31 such as a Patient Safety First California in the procedure room. Partnership for Health video featuring —— Create a “no-interruption” zone and a sponge counting system presented prohibit nonessential conversation by Gibbs (available at http://www. and activities, including rushing the hospitalcouncil.org/post/surgical-safety- count. preventing-retained-surgical-items), AORN —— Consider restarting the count for performance evaluations, and audit tools. a group of items (e.g., laparotomy In addition, a June 2014 Pennsylvania sponge) if the count is interrupted. Patient Safety Advisory article, “Distractions —— Conduct the initial count before the in the Operating Room,” includes strate- patient arrives in the surgical area. Extremities gies to reduce distractions in the OR 9 setting.19 11 Physical Environment6 MS16598 The following highlights of the guidelines —— Standardize the layout of procedural may be useful to healthcare facilities seek- areas to help teams working in new National Quality Forum criteria ing to prevent and reduce RSIs: or unfamiliar locations. The Joint Commission criteria —— Adjust lighting levels to enhance Counting Process Suggestions visibility for adequate inspection of Note: Data Reported to the Pennsylvania —— Standardize count policies for all equipment and viewing of the white Patient Safety Reporting System from January procedures.6 board. 2014 through December 2015; as defined by the National Quality Forum and the Joint —— Establish uniform documentation of the count process across all pro- Team Communication and Commission. Not all RSI Events involved female patients. cedural areas, including areas where Interaction emergent procedures may be per- Develop policies that address physician- formed (e.g., emergency department, staff interaction, which may include: behind because the risks of infection and intensive care unit, or at the bedside —— Requiring physician acknowledg- trauma related to removal were believed on a nursing unit). ment that the count is correct prior to exceed the risks of retention. —— Reconcile the count so the entire to completion of skin closure, per- PREVENTION GUIDELINES team is involved and supports the forming a systematic sweep of the request.6 wound before closing, and examin- Updated AORN and Joint Commission —— Require full counts for breaks or ing the vagina after delivery.2,6 guidelines provide prevention methods shift changes such as lunch breaks.18 to help perioperative team members Vol. 14, No. 1—March 2017 Pennsylvania Patient Safety Advisory Page 33 ©2017 Pennsylvania Patient Safety Authority R E V I E W S & A N A LY S E S —— Calling out when an instrument is LIMITATIONS sponge. Detecting and reporting RSIs placed into a body cavity and not Limitations of this study include scant may help to determine patterns and root immediately removed.2,6 detail in some PA-PSRS reports, the causes using a definition decided upon —— Alerting the team when packing is potential to misinterpret information in by the healthcare facility. Attention to placed into a body cavity and not the narrative descriptions in PA-PSRS components of the surgical item counting immediately removed. reports, and the possibility that reporters process may help prevent RSIs. AORN —— Requiring team affirmation that the used terms not included in the search and the Joint Commission suggest stan- patient meets criteria for an intraop- strategy. The information provided by dardizing counting protocols; providing erative x-ray to screen for RSIs.6 PHC4 may not have included all surgical visual cues when sets are incomplete; procedures performed during the analysis minimizing distractions; and promot- Systems Approach to period, and some RSIs may not have been ing a systems approach to performance Performance Improvement18 identified or reported through PA-PSRS. improvement. —— Respond to errors with a focus on CONCLUSION ACKNOWLEDGMENTS process improvement using human factors principles, rather than indi- RSIs are uncommon, but they do occur, Kimberly A. Farley, BSN, RN, Gwynedd vidual blame. and may cause direct patient harm. In Mercy master’s degree student in science —— Conduct an investigation regard- events reported through PA-PSRS, the of nursing, provided consultation and ing any adverse event or near miss most common locations for RSI are the contributed to data acquisition for this related to RSIs. abdomen and pelvis, followed by the article. Edward Finley, BS, Pennsylvania vagina and chest. The most common type Patient Safety Authority provided data of item that is retained is the surgical analysis and interpretation. NOTES 1. The Joint Commission. Preventing unin- 6. The Joint Commission, Division of Drug Administration (FDA); 2008 Jan 5 tended retained foreign objects. Sentinel Health Care Improvement. Strategies [accessed 2016 Jul 07]. Available: http:// Event Alert. 2013 Oct 17;(51):1-5. PMID: to prevent URFOs. Quick Saf. 2016 www.fda.gov/MedicalDevices/Safety/ 24143853. Jan;(20):1-3. Also available: https:// AlertsandNotices/PublicHealth 2. Gibbs VC. NoThing Left Behind® www.jointcommission.org/assets/1/23/ Notifications/ucm062015.htm. prevention of retained surgical items multi- Quick_Safety_Issue_20_Jan_2016.pdf. 11. Wood A. (Senior Perioperative Nursing stakeholder policy. 2015 Jan. Also available: 7. Hospital-acquired conditions. [internet]. Specialist at Association of periOperative http://www.nothingleftbehind.org/. Baltimore (MD): Centers for Medicare Registered Nurses). Conversation with: 3. Patient sues hospital after forgotten surgi- and Medicaid Services (CMS); 2016 Pennsylvania Patient Safety Authority. cal sponge costs her portion of intestine. Aug 19 [accessed 2016 Jul 06]. Available: 2016 Feb 11. [internet]. Simi Valley (CA): CBS Los https://www.cms.gov/medicare/medicare- 12. The Joint Commission. Frequently Asked Angeles; 2014 Jun 17 [accessed 2016 Jul fee-for-service-payment/hospitalacqcond/ Questions: retained foreign object after 05]. 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Vol. 14, No. 1—March 2017 Pennsylvania Patient Safety Advisory Page 35 ©2017 Pennsylvania Patient Safety Authority PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 14, No. 1—March 2017. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority. Copyright 2017 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to http://visitor.constantcontact.com/ d.jsp?m=1103390819542&p=oi. To see other articles or issues of the Advisory, visit our website at http://www.patientsafetyauthority.org. Click on “Patient Safety Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Pennsylvania Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (Mcare) Act. Consistent with Act 13, ECRI Institute, as contractor for the Authority, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the Pennsylvania Patient Safety Authority, see the Authority’s website at http://www.patientsafetyauthority.org. An Independent Agency of the Commonwealth of Pennsylvania ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. 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