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Hard to believe it’s been over 3 years since our last column on RSI’s (retained surgical items) or RFO’s (retained foreign objects), especially since “unintended retention of a foreign body” remains The Joint Commission’s top reported sentinel event. There were 111 such events reported to The Joint Commission in 2018 (TJC 2019a) and 116 in 2017 and 60 so far in the first half of 2019 (TJC 2019b).
But there have been some interesting, and troubling, trends. While surgical sponges remain the most frequently retained surgical items, the nature of retained items has been changing over the last few years and a number of unusual items have been reported.
Three cases recently published by the California Department of Public Health (CDPH) provide insight into factors contributing to retention of some surgical items.
The first incident recently published by the CDPH (CDPH 2019a) illustrates how multiple factors contributed to retention of a viscera retainer after a hernia repair. That retained foreign object was found during a second surgery conducted after the patient presented several weeks later with an infected wound that had opened.
The original case had been the last case of the day and the most complicated. It started out as a laparoscopic hernia repair but was converted to an open procedure because the hernia was large. During the procedure, the surgeon requested a silastic viscera retainer (VR). The relief circulating RN (CRN) was unfamiliar with this and the OR tech told him what it as and where to find it in a storage cabinet. The CRN “was nervous” and dropped the VR as he attempted to put it on the sterile field and it fell to the floor. He got another VR and put it on the sterile field. The VR that fell on the floor was later put in the kick bucket. Apparently neither VR was written on the whiteboard.
During the surgery the viscera retainer was placed over the intestines to prevent suturing the mesh to the bowel, then the mesh was placed on top.
At some point during the surgery there was a change in personnel. The First-Assist Physician’s Assistant (FAPA) stated she stayed 2 hours past her shift to assist the surgeon and then she asked to leave the surgery. An OR tech came in to relieve the FAPA. The OR tech stated he did not remember receiving report from the FAPA that a VR was used during the surgery. The OR tech also stated he did not remember seeing the ring or the tail from the VR on the surgical drape outside the patient’s incision.
The surgeon, when interviewed several months after the initial surgery, could not recall putting the VR in or taking it out, but did recall, as he was closing, asking for a count and being told it was correct, so he proceeded to close. Both the CRN and the OR tech saw the VR in the kick bucket and thought the count was correct.
It was not clear who actually put the VR in, but it was speculated that might have been the FAPA before being relieved by the OR tech.
The second case (CDPH 2019b) involved retention of a surgical ribbon malleable instrument, measuring 12.99 inches by 2 inches after a C-section and tubal ligation surgery. The patient returned to the ED with abdominal pain 29 days after surgery and CT scan showed a large metallic density foreign body.
Specialty technician (Tech 1) explained that, during the third count, she was holding a retractor while assisting the surgeon to retract the patient’s skin. Tech 1 stated that she started counting retractors from the patient to the table by visualizing the retractor and verbally counting out the number corresponding to that retractor. Tech 1 advised she counted 7 retractors. However, she explained that she verbally out load said the number “8”, assuming the eighth retractor was already inside the basket. Tech 1 stated “I did not have a visual of the eighth retractor. I assumed the eighth retractor was inside or behind the basket.” (The basket is a metal wire container where the instruments are placed).
The Surgical Services Director explained that the surgical team staff had not performed the instrument counts as mandated by facility policy, explaining that the surgical instruments were not counted audibly nor viewed concurrently by the circulating nurse and the scrub tech and confirming that the eighth retractor was not visualized by the two surgical staff.
Tech 1 explained that the “third” count occurred at the surgical suturing of the peritoneum. She stated that several distractions occurred during this part of the procedure. The primary surgeon dismissed the assistant surgeon at this point of the procedure. Tech 1 indicated that she then assumed the role of assistant to the primary surgeon. Tech 1 described having to hold an instrument to retract the wound with her right hand, while holding a needle holder with her left hand in preparation for the surgeon's next step in the procedure. Her attention to the surgeon’s needs made it difficult for her to visualize all the retractors as the counts were performed. When the circulating nurse named a countable item, the tech used her head to point to the countable item. At this point, the patient began to cough, and the tech thought she might have vomited. At this point the surgeon asked for an instrument to hold back the wound as the patient’s body movement interrupted the surgical suturing of the wound. Tech 1 handed the surgeon a ribbon malleable retractor.
Tech 1 also explained that the ribbon malleable retractor was usually placed inside or in back of the basket. The circulating nurse stated that during the third count she called out “retractors” and thought the tech verbally replied aloud the number “8”. She said she did not actually see that retractor herself. Neither the nurse nor the tech actually saw the 8th retractor. They assumed it was in the basket.
There were several other distractions as the primary surgeon informed the assistant surgeon to leave. The surgeon’s phone rang several times during the third count, before being answered by the anesthesiologist. The patient had also vomited, which is why the surgeon asked for the malleable ribbon retractor.
The third case (CDPH 2019c) also involved retention of a ribbon retractor, measuring about 33 cm long, 5 cm wide, and one millimeter in thickness, after an abdominal hysterectomy by a resident physician. The day after surgery the patient complained of left sided chest pain radiating to her shoulder and a CXR was read as showing a left lower lobe infiltrate with small amount of pleural fluid. The patient was discharged but 20 days post-op she returned with abdominal pain and X-rays show the foreign body (this was actually the “lower lobe infiltrate” previously seen on CXR).
According to the surgical tech (ST), the surgeons used a standard laparotomy tray but, when they closed the abdomen, they asked for a malleable ribbon retractor. Apparently, only 2 counts were done. No final count was performed. “We didn't do final count for instruments, because (the} first (count} was correct.”
So, there is clearly a pattern in these cases.
First, and foremost, counts need to be conducted under “sterile cockpit” conditions. That means that all must focus attention on the count and there should be no extraneous conversations or other distractions.
Communication breakdowns are a key feature of most sentinel events and these are no different. In the first case, the OR tech stated he did not remember receiving report from the FAPA that a VR was used during the surgery.
Third, the potential impact of personnel changes is obvious in the above examples. In one case, the role of one of the persons responsible for the count was changed and she now was performing two roles, causing less than ideal attention to doing the count.
Other distractions included the surgeon’s phone ringing several times during a count. The issue of personal phones in the OR is beyond the scope of today’s column but the case at hand is a great example of a reason we counsel against allowing phones in the OR. Our Patient Safety Tips of the Week May 21, 2013 “Perioperative Distractions”, March 17, 2015 “Distractions in the OR”, and July 21, 2015 “Avoiding Distractions in the OR” had detailed discussion about use of cell phones and other wireless devices in and around the OR with multiple examples of distractions related to such in the OR. There are a multitude of issues related to cell phones in the OR including not only interruptions and distractions but also infection control issues, security and confidentiality issues, and detrimental effects on communication in the OR. Our recommendation is for all the OR team to leave their cellphones at the main OR desk where someone can triage incoming phone calls and messages.
Time of day was clearly a factor in the first case. It was the last case of the day and the First-Assist Physician’s Assistant (FAPA) stated she stayed 2 hours past her shift to assist the surgeon and then she asked to leave the surgery. In the other, it was not clear why the assistant surgeon was “dismissed” (was it also related to time of day?). Time of day is relevant for the fatigue factor, time pressures, and for contributing to the personnel changes.
Other unanticipated events were also contributing factors. In one, the original item fell on the floor, so a second item had to be put into the sterile field. In another, the patient began to vomit and move around.
There was also a common cognitive bias in at least one of the cases. That is the bias where we “see” what we expect to see and the related cognitive bias “inattentional blindness”. The tech assumed the retractor was in or behind the basked where the instruments were placed even though she did not actually see the instrument.
Unfamiliarity with the device played a role in at least one of the above cases. In the first case, the circulating nurse did not know what the device was or where it was located. The “ring” attached to the device was likely also inadequately anchored to remain visible.
Lastly, each of these cases involved problems with the “final” count. There is typically a count done when the wound cavity is closed and then a final count after the skin wound is closed. Most surgical instruments are introduced well before the wound cavity closure stage. But, in the cases with these retractors/retainers, the instrument is often introduced only after the penultimate count (the one following wound cavity closure) has been done. There is probably a natural tendency to forget to add that item to the whiteboard or whatever other tool is being used to log in instruments. This is also relevant with regard to the “methodical wound exploration” (MWE). The MWE is typically done before the “closing” count. But that means there is no MWE after the wound cavity is closed and the skin is sutured, i.e there is no MWE done just before the “final” count.
Also striking in the CDPH cases were the missed opportunities to identify the RSI soon after the fact, causing the patients unpleasant symptoms for several weeks before the correct diagnosis was made.
When we first planned this column many months ago, it was titled “Yet Another Unusual RSI”. But it turns out it is not so unusual. In fact, the most frequently reported retained instrument is the malleable or ribbon retractor according to NoThing Left Behind® (NoThing Left Behind® 2019). NoThing Left Behind® states “we have a better understanding of why malleable retractor cases have occurred. Usually during the closure of the wound the malleable retractor has been added to the field often as an add-in to the case, rather than as a part of the instrument tray. In most of the cases there has been some kind of distraction which has diverted attention from the field and the malleable has slipped away out of view. This alone should not lead to retention because the practice of instrument counting should detect the missing item. However either the instrument counts weren't performed or the added-on malleable wasn't included in the counting documentation and the retractor has been left inside.”
Interestingly, the solution proposed to prevent retention of the malleable ribbon retractors is use of the plastic fish viseeral retainer, which was the item retained in the first CDPH case. “These cases can be prevented with the use of a plastic fish visceral retainer which has a long cord and a ring at the end. The ring is clamped to the surgical drapes when the retainer is placed inside the abdomen during closure. The cord and ring are actually the safety part of the retainer.” (NoThing Left Behind® 2019).
Back in our November 5, 2013 Patient Safety Tip of the Week “Joint Commission Sentinel Event Alert: Unintended Retained Foreign Objects” we mentioned another case of a retained Glassman viscera retainer. That was from the investigation of a RFO reported by the California Department of Public Health (CDPH CA00235788). In this case the retained foreign object was a Glassman viscera retainer, which is a fish-shaped soft flexible device that folds into a roll and is used to shield from nicks and punctures. All the “counts” in the case were reported to be correct. But apparently when the “fish” was added to the surgical field it was not added to the count verbally or on the count board (see our January 8, 2013 Patient Safety Tip of the Week “More Lessons Learned on Retained Surgical Items” regarding addition of items to the surgical field). In addition, the “fish” apparently has a string attached to promote retrieval but that string had been cut by the surgeon. Guidelines for surgical sponges have always emphasized the importance of not cutting or altering the sponges. Obviously the same should apply to other things, like the “fish”.
In the current CDPH case (CDPH 2019a) staff did not recall seeing the fish ring or the connecting “tail”. The hospital’s plan of correction included re-educating surgical staff on use of a viscera retractor and methods for anchoring the FISH ring when the view is obscured. So it’s clear that you need to use the “Fish” correctly to take advantage of its built-in safety features.
While sponge accounting systems are at the top of everyone’s list of tools to prevent RSI’s because surgical sponges are far and away the most commonly retained surgical items, our previous columns warn you not to lose sight of the fact that all sorts of other RSI’s have been appearing more and more (blue towels, Kerlix, cautery tips, Glassman viscera container, KOH cup, instrument labeling tape, Jackson Pratt drain bulbs, Rainey clips, and, yes, a cell phone, and others). Even the newest radiofrequency identification and tracking systems would miss most of those items.
In addition to our many prior columns on RSI’s/RFO’s listed below, there are many good resources available to help prevent these. NoThing Left Behind® (NoThing Left Behind®) is the preeminent resource. Others include AORN (AORN 2018), the American College of Surgeons (ACS 2016), The Joint Commission (TJC 2017, TJC 2013), Pennsylvania Patient Safety Authority (Wallace 2017). Verna Gibbs,founder and director of NoThing Left Behind®, also recently provided some great tips for surgeons, nurses, and all OR staff for avoiding RSI’s (Gibbs 2019). And Victoria Steelman, another author of frequent publications on RSI’s, and her colleagues have also published recent articles on RSI’s (Steelman 2018, Steelman 2019)
Our prior columns on retained surgical items/retained foreign objects (RSI’s/RFO’s):
TJC (The Joint Commission). Sentinel event statistics released for 2018. TJC Online 2019; March 13, 2019
TJC (The Joint Commission). Sentinel event statistics released for first 6 months of 2019 with new suicide categories. TJC Online 2019; August 14, 2019
CDPH (California Department of Public Health). Compleilnt Intake Number; CA00569261; CDPH 2019; Published June 18, 2019
CDPH (California Department of Public Health). Compleilnt Intake Number; CA00540695; CDPH 2019; Published January 16, 2019
CDPH (California Department of Public Health). Compleilnt Intake Number; CA00584143; CDPH 2019; Published January 18, 2019
NoThing Left Behind®: A National Surgical Patient Safety Project to Prevent Retained Surgical Items. Prevention of Retained Surgical Instruments
CDPH (California Department of Public Health). Event ID CA00235788
NoThing Left Behind®: A National Surgical Patient Safety Project to Prevent Retained Surgical Items
AORN (Association of periOperative Registered Nurses). Retained Surgical Items. 2018
ACS (American College of Surgeons). Revised statement on the prevention of unintentionally retained surgical items after surgery. October 1, 2016
TJC (The Joint Commission). New Sentinel Event Alert video: Preventing Unintended Retained Foreign Objects. Joint Commission Online 2017; October 25, 2017
TJC (The Joint Commission). Sentinel Event Alert. Preventing unintended retained foreign objects. Issue 51 October 17, 2013
Wallace SC. PPSA (Pennsylvania Patient Safety Authority). Retained Surgical Items: Events and Guidelines Revisited. Pennsylvania Patient Safety Advisory 2017; 14(1): 27-35
Gibbs V. 5 Keys to Preventing Retained Surgical Items. Use these strategies so there's nothing left behind. Outpatient Surgery 2019; XX(4): April 2019
Steelman VM, Shaw C, Shine L, Hardy-Fairbanks AJ. Retained surgical sponges: a descriptive study of 319 occurrences and contributing factors from 2012 to 2017. Patient Safety in Surgery 2018; 12:20 Published 29 June 2018
Steelman VM, Shah C, Shine L, et al. Unintentionally Retained Foreign Objects: A Descriptive Study of 308 Sentinel Events and Contributing Factors. Joint Commission Journal on Quality and Patient Safety 2019; 45(4): 249-258
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