The purpose of this activity is to enable the learner to identify the 3 most common surgical errors, factors contributing to their etiology in the surgical setting and how they can be prevented and mitigated.
After completing this course, the learner will be able to:
Medical errors are understandably of great concern in the health care setting due to the serious ramifications that they pose to patients. It has been estimated that approximately 1 every 10 hospitalized patients will experience an adverse event. Nearly 2/3 of all these adverse events will be associated with the surgical team (Vries et al, 2008).
In a 2009 survey of American surgeons, Shanafelt et al. (2010) noted that approximately 9% of surgeons surveyed reported they had made a major medical error in the last 3 months. The three main preventable events that occur in an operating room are: “wrong surgery” errors, retained surgical items and surgical fires.
There are three types of “wrong surgery” errors which occur: the wrong patient, the wrong procedure and the wrong surgical site. The incidence of “wrong surgery” errors has been estimated to be approximately 2000 cases per year.
The Joint Commission, which is an organization responsible for accrediting and certifying health care organizations in the United States, has emphasized the need to implement risk reduction interventions to prevent surgical wrongs. The Joint Commission developed the Universal Protocol in 2004 which was a measure implemented to decrease the incidence of surgical errors occurring in the United States. The Universal Protocol includes preoperative verification of the patient and the site, surgical marking of the site, and a time-out before any planned procedure. In spite of this measure, the number of wrong site surgeries continued to increase as reported by Stahel et al. (2010).
The WHO established the Safe Surgery Checklist in 2010 which identifies 3 phases of an operation: The “sign-in” phase before anesthesia, the “time-out” phase before the surgical incision and the “sign-out” phase before the patient leaves the operating room. Kearns et al. (2011) noted that compliance after implementation of the WHO surgical check list improved from 61.2% to 79.7% on the preoperative portion and from 67.6% to 84.7% on the postoperative portion. Additionally, Vats et al. (2010) conducted a review of their pilot program in implementing the WHO Safe Surgery Checklist and identified multiple variables that affect compliance. They had instances when the surgical checklist was improperly used, instances of hasty implementation of the checklists because of pressure from surgeons and anesthesiologist. They also noted that dismissive responses were provided to checklist questions that went unchallenged and finally, the checklist was occasionally completed without key people being present.
Vats et al. (2010) also identified some barriers to the implementation of the surgical checklist including:
Team members’ perceptions and attitudes in response to the WHO surgical checklist has been mostly positive. However, some studies have reported some surgeons were not too enthused about the implementation of checklists in the operating room (Fourcade et al, 2011). Overall nurses and anesthesia providers were noted to be more supportive.
One of the biggest successes of the surgical checklist implementation has been its ability to increase team communication. This is critical because most clinical errors, including wrong site surgery, have been shown to result from a lack of communication between team members.
Some authors have suggested that the time-out process should be driven by the surgeon since they are responsible for knowing which procedure they are planning to perform. Most of the checklist process is focused on patient identification and preparation for the procedure. It is the surgeon who first identifies the correct patient and marks the correct site. A lot of the information reviewed in the surgical checklist is within their care domain.
The incidence of retained surgical items has been estimated to be as high as 2000 cases per year in the United States. The most commonly retained surgical item is a surgical sponge. These are easily retained because of the small size and their ability to blend with surrounding tissue when soaked in blood. Another name for a retained surgical sponge is a gossypiboma. Of all retained surgical instruments, clamps and retractors are the most common. There are instances when larger dressing materials have been retained in association with negative pressure wound therapy dressings used for complex wounds (Ahmed et al, 2010).
Retained surgical items are one of the more common medical errors occurring in the surgical setting and it poses a surgical patient safety problem. The term a retained surgical item is now been used preferentially over retained foreign body to help distinguish it from foreign bodies left behind intentionally such as shrapnel or bullets. Specifically, retained surgical objects refers to surgical instruments or supplies that are used by surgical providers to heal but were unintentionally left inside the patient. These retained surgical items have the potential to cause harm to the patient (Gibbs, 2011). Retained surgical items may not be discovered until years after the operation when they are incidentally found. The issue of retained surgical items carries the potential of having serious medical and legal implications for the patients, physicians and hospitals involved.
In order to meet the requirements to be classified as a case of retained surgical items, an incision must have been made during the case and surgical items must have been used inside the patient. Surgical items typically retained inside a patient are classified into 4 types: sponges, needles, instruments and miscellaneous small objects. One may ask how surgical instruments could be left inside a patient? How could you forget a needle inside a body cavity and how do you misplace a retractor inside of someone’s body? It is sobering to realize that retained surgical item cases are not that uncommon in the practice of surgery.
Orosco et al. (2012) performed a retrospective analysis of surgery related malpractice payments using data over a sixteen-year period from the National Practitioner Data Bank. They noted that “retained foreign body” was the third most commonly cited malpractice allegation at around 6 percent. The top five malpractice allegation causes are; improper performance; Allegation, not otherwise classified; Retained foreign body; improper management and Wrong body part.
As a matter of fact, in cases of retained foreign bodies, the legal teams have been known to use the retained surgical items as proof that malpractice has occurred. Also, it is critical to note that in the case of retained foreign bodies the statute of limitations is extended indefinitely in most states.
Cases of retained surgical items have been reported around the world for decades. It was originally purported that patient specific and case specific factors were the most significant causes for these retained surgical object cases. However, from recent literature, we have learned that retention of surgical objects is less affected by patient factors such as body habitus or case dependent factors such as surgically emergent operations but is more affected by the practitioners in the operating room and the working environment that has been cultivated amongst the surgical staff (Mcintyre, 2010). It has been clearly shown that more retained surgical items cases occur in standard elective surgical procedures.
Multiple factors have been identified as increasing the risk for retained surgical items. These factors include:
Interestingly, trainee presence has been shown to decrease the risk of retaining surgical items. Trainees in this settings refers to residents, fellows and medical students.
The American College of Surgeons believes that in addition to faulty care processes occurring in the operating room, poor communication among the perioperative staff plays a causative role in the occurrence of surgical errors. Especially when surgeons dismiss miscounts reported by nursing and other staff. Examples of patient care practices contributing to retained surgical items include poorly performed sponge and instruments counts, poorly executed wound exploration and incomplete performed or misinterpreted intraoperative radiographs.
There have been reported cases in literature where the final count was called as incorrect and yet the patient leaves the operating room with the item still inside their body. Understandably, this happens on very rare occasions (Gibbs, 2011).
To help address this problem, “NoThing Left Behind” was created in 2004. This is a surgical patient safety initiative which was established to understand the etiology of retained surgical items and to help create practices to prevent the retention of surgical items. With the goal being to ensure that retained surgical items become a “never happen event”. Hospitals voluntarily participate in this program by reporting events when surgical items are left in a patient as well as near miss events and how they were ultimately identified. The overall goal was to create a database for the development and implementation of safer multidisciplinary practices in the surgical setting.
The best defense we have for preventing retained surgical items is the surgical count. Instruments and sponges are counted during this process. All sponges used during surgical procedures must have a radiopaque indicator. The Association of Operating room nurses (AORN) recently published an updated recommended practices policy which is widely accepted as the gold standard of practice in performing surgical counts. It details specific points during a case when a surgical count should be performed which include:
During the counting process, the AORN recommends that the sponges should be separated and counted audibly and should be viewed by two individuals during the counting process. Typically, the two individuals performing the count are the scrub nurse (or scrub tech) and the circulating nurse. If there is a discrepancy in any of the counts, the entire surgical team is responsible for locating the missing item. If the item cannot be found, manual exploration of the surgical site by the surgeon is recommended. If the item still cannot be found, the next step is an intraoperative radiograph prior to the final closure of the body cavity being operated on. Next the film should be read by a radiologist who should be alerted as to the purposes of the film. Before the reversal of anesthesia, the radiologist should communicate the results of the film to the responsible surgeon and confirm that the entire surgical field has been imaged. (AORN, 2015). The AORN noted that if there was a persistent discrepancy between the initial and final counts the risk of a retained surgical item increased by one hundred fold.
Currently, there are three technological gadgets for sponge management: a device that counts 2D matrix labeled sponges, a device which detects radiofrequency tagged sponges and a device that can do both detection and counting of sponges.
When retained surgical item cases occur, the hospital usually has to acknowledge the mistake to the patient with an apology. Also, all the cost incurred secondary to the retained objects are usually paid by the hospital.
Operating room fires occur near or around a patient but they differ from surgical fires which occur inside or on a patient. Surgical fires can be very lethal very quickly. The main challenge faced is due to the fact that they occur so infrequently, the surgical staff are usually unaware of how to manage them. The incidence of surgical fires is estimated at approximately 550 – 650 fires per year (Clarke & Burley, 2012).
For a surgical fire to occur there are three necessary components; an oxidizer, an ignition source and fuel. These have been termed “the fire triad” (Roy & Smith, 2011). Potential fuel sources are innumerable, but some include the endotracheal tube, the head rest, sponges, drapes, hair, fat and gastrointestinal gases. Oxidizers include oxygen and nitrous oxide. The most common ignition source is the electrocautery device. Other sources include heated probes, argon beam coagulators, drills and burrs, defibrillator paddles or pads, lasers and fiber optic light cables.
Of all surgical specialties, ENT (Otolaryngology) surgeons tend to the most experienced with surgical fires because they often operate with ignition sources close to the airway.
In 2012, Gibbs proposed that in surgical fires the three members of the operating room team (nurses, surgeons and anesthesiologist) should each be tasked with controlling a component of “the fire triad”. Anesthesia should control the oxidizers given that they have direct access to it. Surgeons should control the ignition source since they have access to it and nurses should manage potential fuel sources and be tasked with extinguishing flames given they are the most mobile member of the team.
Mehta et al. (2010) reviewed and conducted an evaluation of closed malpractice claims from 35 insurance companies in order to analyze the details associated with OR fire claims. Patients in fire claims were more likely to be under monitored anesthesia care (MAC) or regional anesthesia (RA). Oxygen was identified as the oxidizer source in 95% of all electrocautery fires. They concluded that the presence of MAC and supplemental oxygen was a predominant factor in the cause of operating room fires. Recognition of the fire triad, particularly the critical role of an open delivery system for supplemental oxygen during electrocautery use, is crucial to prevent OR fires. Continuing education and communication amongst operation room staff in addition to fire prevention protocols in high-fire-risk procedures were proposed as interventions to reduce the occurrence of OR fires.
When a surgical fire occurs, stop the procedure, remove whatever is on fire, and immediately cut the oxygen supply. Airway fires are a significant risk in the OR, but with awareness and preventive measures, they can be easily avoided.
Water based skin preparations are rarely used because they take up to 15 minutes to dry and must be fully dry to be effective. Alcohol based preparations, take approximately 3 minutes to dry on hairless skin. However, if applied to hair bearing areas, alcohol based skin preparations may take as much as 60 minutes to completely dry. Therefore, alcohol based skin preparations should be avoided for hair bearing areas and in instances when an oxygen-enriched environment is required. For example, in head and neck surgery cases. The time out process can include an update to the surgical team whether or not adequate drying time has occurred.
A 40-year-old female is scheduled for an elective laparoscopic gastric bypass surgery. The surgery starts on time with the scheduled surgical team. The team of surgeons consists of the attending surgeon, the first surgical assistant who is a chief resident (last year of training), a surgical intern (in their first year of training) and a medical student. Prior to getting to the operating room the circulating nurse and the anesthesia provider both confirm with the patient the procedure she is scheduled to have and who it is supposed to be performed by as well as the other items on the surgical checklist. The attending physician is present in the room during the surgical “time-out”. The case is scheduled to last for 2 hours and it starts on time. However, 45 mins into the case the attending surgeon realizes that he will not be able to safely complete the surgery laparoscopically and decides to convert to an open procedure. This delays the case by 1.5 hours but eventually it is completed 3.5 hours after its start time. The attending surgeon has 3 other cases scheduled for that day and after ensuring that the patient is stable, he leaves the room putting the chief resident in charge. The residents begin closing the surgical incision. However, because the case is delayed the circulating nurse who initially began the procedure is no longer in the room given that she was relieved for lunch. The current circulating nurse counts the surgical sponges with the scrub tech and realizes that one sponge is missing. The count is redone 2 more times and still one sponge is noted to be missing. The chief resident has finished closing the skin at this point and is absolutely certain that the sponge is not in the patient because he did a complete quadrant check prior to closing the surgical incision. You are the charge nurse on duty and you are called into the operating room by the circulating nurse for guidance.
The circulating nurse should immediately notify the attending physician of the incorrect count. Once he returns to the operating room the wound should be reopened and the body cavity properly examined by the attending physician. If the sponge remains missing, intraoperative radiographs should then by performed and a formal radiology read should be communicated to the surgeon prior to reversal of anesthesia.
You are a circulating nurse in a busy academic teaching hospital. You are assigned to a same day surgical procedures and your first case is on a 15-year-old female scheduled for a tonsillectomy. Prior to wheeling the patient back to the operating room. You note that no surgical site has been marked. You are not sure what to do so you call the charge nurse asking for assistance.
In 2007, the World Health Organization initiated an international High 5s project in an attempt to address patient safety problems including preventing wrong site and wrong procedure surgery. In 2012, the International High 5s board in conjunction with the Haute Authorité de Santé published a Guide to Surgical Site Marking. The guide establishes and clarifies situations during which marking may not be done or may have to be amended for clarity. Examples include: tonsillectomy, laryngectomy or adenoidectomy cases. Also, marking is not required in the following cases: involving premature infants (the permanent marker might tattoo the infant), life-threatening emergencies, bilateral cases such as ovaries, dental cases and transcutaneous approach vascular cases when the site of entry is not certain. In all cases, it is important to adhere to all institutional policies. In this case, the nurse is best off clarifying the hospital policy with the charge nurse. In some hospitals marking the site where the organ is located is necessary which in this case will be the right upper quadrant. However, with a laparoscopic approach the patient will likely end up with an incision in places other than the right upper quadrant making the marking futile. In such cases it is more important to confirm with the patient and the physician which organ is going to be removed.
Ahmed, F., Swan, M., Flynn, M., & Tiernan, E. (2010). Retained VAC™ therapy sponge as a complication of abdominoplasty. Journal of Plastic, Reconstructive & Aesthetic Surgery, 63(5). doi:10.1016/j.bjps.2009.09.006
ARON (2015) Guideline for prevention of retained surgical items. AORN Journal.102(6). doi:10.1016/s0001-2092(15)01014-5
Chabloz C., Fanget K., Fort B., & Leclercq, M. (2012) GUIDE TO SURGICAL SITE MARKING “Performance of Correct Procedure at Correct Body Site: Correct Site Surgery”. [Brochure].
Clarke, J. R., Bruley, M. E., (2012). Surgical Fires: Trends Associated with Prevention Efforts Pa Patient Saf Advis 9(4): 130-5
Fourcade, A., Blache, J., Grenier, C., Bourgain, J., & Minvielle, E. (2011). Barriers to staff adoption of a surgical safety checklist. BMJ Quality & Safety, 21(3), 191-197. doi:10.1136/bmjqs-2011-000094
Gibbs, V. C. (2011). Retained Surgical Items and Minimally Invasive Surgery.World J Surg World Journal of Surgery, 35(7), 1532-1539. doi:10.1007/s00268-011-1060-4
Gibbs, V. C. (2012). Thinking in three's: Changing surgical patient safety practices in the complex modern operating room. World Journal of Gastroenterology WJG, 18(46), 6712. doi:10.3748/wjg.v18.i46.6712
Kearns, R. J., Uppal, V., Bonner, J., Robertson, J., Daniel, M., & Mcgrady, E. M. (2011). The introduction of a surgical safety checklist in a tertiary referral obstetric centre. BMJ Quality & Safety, 20(9), 818-822. doi:10.1136/bmjqs.2010.050179
Mcintyre, L. K. (2010). Gossypiboma. Arch Surg Archives of Surgery, 145(8), 770. doi:10.1001/archsurg.2010.152
Mehta, S. P., Bhananker, S. M., Posner, K. L., & Domino, K. B. (2013). Operating Room Fires. Anesthesiology, 118(5), 1133-1139. doi:10.1097/aln.0b013e31828afa7b
Orosco, R. K., Talamini, J., Chang, D. C., & Talamini, M. A. (2012). Surgical Malpractice in the United States, 1990–2006. Journal of the American College of Surgeons, 215(4), 480-488. doi:10.1016/j.jamcollsurg.2012.04.028
Roy, S., & Smith, L. P. (2011). What does it take to start an oropharyngeal fire? Oxygen requirements to start fires in the operating room. International Journal of Pediatric Otorhinolaryngology, 75(2), 227-230. doi:10.1016/j.ijporl.2010.11.005
Shanafelt, T. D., Balch, C. M., Bechamps, G., Russell, T., Dyrbye, L., Satele, D., . . . Freischlag, J. (2010). Burnout and Medical Errors Among American Surgeons. Annals of Surgery, 251(6), 995-1000. doi:10.1097/sla.0b013e3181bfdab3
Stawicki, S. P., Moffatt-Bruce, S. D., Ahmed, H. M., Anderson, H. L., Balija, T. M., Bernescu, I., . . . Cook, C. H. (2013). Retained Surgical Items: A Problem Yet to Be Solved. Journal of the American College of Surgeons, 216(1), 15-22. doi:10.1016/j.jamcollsurg.2012.08.026
Stahel, P. F. (2010). Wrong-Site and Wrong-Patient Procedures in the Universal Protocol Era. Arch Surg Archives of Surgery, 145(10), 978. doi:10.1001/archsurg.2010.185
The Joint Commission. Sentinel event data: event type by year (Visit Source). Accessed March 27, 2016
Vats, A., Vincent, C. A., Nagpal, K., Davies, R. W., Darzi, A., & Moorthy, K. (2010). Practical challenges of introducing WHO surgical checklist: UK pilot experience. Bmj, 340(Jan13 2). doi:10.1136/bmj.b5433
Vries, E. N., Ramrattan, M. A., Smorenburg, S. M., Gouma, D. J., & Boermeester, M. A. (2008). The incidence and nature of in-hospital adverse events: A systematic review. Quality and Safety in Health Care,17(3), 216-223. doi:10.1136/qshc.2007.023622
www.nothingleftbehind.org. Accessed March 27, 2016