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The care of the surgical patient is dependent upon doctors, nurses, technicians and both office and hospital staff. Like all humans, despite their best efforts, they make mistakes. Encouraging them to “try harder” simply will not work.

To reduce surgical errors we need to identify root causes and institute system-based processes to prevent them.

Studies have suggested specific areas that offer opportunities for improvement. Kim et al.^[1] noted that adverse events from surgical intervention are more commonly due to preoperative and/or postoperative errors. These include delay in diagnosis and/or treatment and communication errors between the healthcare team and the patient/family or other members of the healthcare team. Process measures that can address these issues include:

• Requiring all preoperative orders to be written not verbal
• Utilization of surgical checklists
• Using the SBAR (Situation, Background, Assessment, Recommendation) method of communication
• Verification of specimen labeling, results reporting and medication
• And other system processes.

Surgical intervention is highly operator dependent and involves cognitive and technical skills. Forsyth^[2] considered technical errors to be failures in either execution (91%) or judgement (9%). Execution errors included intraoperative organ injury, breakdown of surgical repairs, and hemorrhage. Although some system processes, such as those that avoid distractions, adopting “crew resource management” and preventing disruptive behavior in the OR, can address errors, they remain entirely dependent upon operator experience, expertise and practice.

The Joint Commission (TJC) reported sentinel events voluntarily submitted from 2015 to 2018. The most common surgical event was “unintended retention of a foreign body”, followed closely by “wrong-site surgery”.^[3] A Minnesota Department of Health report^[4] also found “retained objects” to be the most common operative event reported, followed by “wrong site surgery” and “wrong procedure”. A review of wrong site and wrong procedure errors was recently made available by The Sullivan Group^[5]. A retained foreign body (RFB) continues to be the most commonly reported intraoperative surgical error, and a discussion on the topic of retained surgical sponges was also recently provided by The Sullivan Group^[6].

Retained Foreign Bodies

Stawicki^[7] examined the factors previously reviewed by Gawande^[8] and Lincourt^[9], and also included safety variance, defined as an omission of an accepted safety procedure (e.g. sponge count). The most common RFB was a surgical sponge (51%) but they also found metallic objects (20%), non-metallic objects (19%), and non-sponge textiles (8%). Radiographic imaging (n=51) done at the conclusion of the procedure missed the RFB in 13 (25%). Multivariate analysis showed that four factors were significantly associated with a RFB: BMI (OR=1.1, p=0.019), unexpected operative event(s) (OR=6.97, p=0.002), safety variance (OR=10.7, p<0.001) and procedure duration OR=1.41, p=0.032). 

Moffat-Bruce^[10] performed a meta-analysis of the aforementioned 3 studies and found seven factors to be associated with a significantly increased risk of a RFB: estimated blood loss >500CC (OR=1.64, p=0.016); incorrect count (OR=6.12, p=0.034); multiple procedures (OR=2.09, p=0.004); multiple surgical teams (OR=2.96, p=0.001); operative time (OR 1.67, p=0.037), no surgical count (OR=2.47, p=0.001); and unexplained operative factors (OR=3.38, p= 0.001).

Steelman^[11] reviewed events involving unintentionally retained foreign objects (URFO) reported to TJC October 2012 through March 2018 (n=308), excluding retained sponges and/or guidewires. Instruments (n=102) comprised 33.1% and needles and blades (n=33) comprised 10.7%. The URFOs were most commonly found in the abdomen/pelvis (28.9%), vagina (20.2%), joints (13.6%) and thorax (11.5%). Elements contributing to URFOs most often included human factors (n=333) such as distractions, telephone calls, or multitasking (n=110); leadership issues (n=286) such as inadequate policies and procedures (n=160) or non-compliance with existing policies and procedures (n=94); and communication breakdowns (n=253) most often with the physician (n=104). Disturbingly, a count was reported as performed in only 136 (44.1%) of the 308 cases with 113 counts considered correct despite the URFO. 

A foreign body can be left behind in any patient, in any location and at any time. Just as we practice body substance isolation (BSI) in all patients, we must always take proper precautions and follow policies and procedures to prevent a RFB in all patients, not just in those at high risk. The direct medical costs associated with a RFB have been estimated to be $60,000 - $70,000 per case and liability expenses may be several times that. More importantly, prolonged and/or additional hospitalization is often required and patients may suffer the morbidity and mortality associated with a RFB. Several organizations and researchers^{[12],[13],[14]} have suggested various policies and procedures all of which have merit and can assist facilities in establishing policies and procedures to prevent surgical errors. Although a systems-based approach is required, implementation of even the best policies require execution by members of the operative and healthcare team. 

Disruptive Behavior in the OR

The attending surgeon must demonstrate commitment to patient safety through personal action and interpersonal communication. All too often, the most distracting event in the OR may be disruptive behavior by a member of the surgical team. It has a direct and negative impact on patient safety and simply should not, and cannot, be tolerated. Stress levels can be especially high in the OR but that can never excuse jeopardizing the safety of the patient. All members of the surgical team are professionals who must learn to perform under difficult circumstances without exhibiting behaviors which can be distracting to themselves and other members of the team. Surgeons must lead both by word and by action.

As a Director of Vascular Surgery and Chairman of General Surgery, I have formed personal habits and policies which can help prevent a RFB. Surgical care demands constant attention and focus, without distraction. The advent of cellphones with voice, texting and other attention demanding applications has promoted multitasking, sometimes with fatal consequences. Many people frequently multitask convinced that doing so does not reduce their performance. Research has repeatedly demonstrated that multitasking “takes a toll on productivity”^[15]. Surgeons are no exception, and distractions in the OR can and do lead to surgical errors. In the OR, my practice has been to refer any and all telephone calls, messages and questions regarding other patients to another physician so that my attention is fully devoted to the patient at hand.

Best Practices to Ensure Safety in the OR

Well before the description of a “Surgical Checklist” or a formal “Time Out” it has long been my practice upon entering the OR to confirm the identity of the patient, the planned procedure and the site of the procedure using a “triple check” of the chart, the preoperative physician’s note and the preoperative anesthesia note. More recently I personally mark the procedure site, preoperatively, in concert with the patient and family and confirm this marking immediately prior to induction of anesthesia. 

Intraoperatively, any medications handed to the surgical team are confirmed by two members of the OR team, each reading the label out loud and confirming the medication and strength. Medications not immediately used must be clearly labelled. Any unknown solution or unlabeled medication is immediately passed off the operative field. Surgical activity may be briefly suspended, if possible, to allow breaks and orderly shift changes among the staff. Communication between the nursing staff should not be interrupted during this critical time. Sponge, needle and instrument counts should be performed by two individuals at all breaks and shift changes.

The surgeon should announce when closure is about to begin and all foreign bodies, with the exception of implants, should be removed or be visible. A sponge count is mandatory prior to closure. The nursing staff should not be interrupted, distracted or rushed during this critical phase of the procedure. Prior to closure the surgeon must perform a comprehensive cavity search to confirm that there are no unintended foreign bodies remaining in the wound.

Never, ever challenge the accuracy of an incorrect count! No more ominous words were ever spoken than “Well, it’s not in the wound!” An incorrect count mandates a second cavity sweep and a complete repeat count. Once the wound is closed, the surgeon should verbally request a final comprehensive count. Any discrepancy in the count or any concern regarding the possibility of a RFB mandates that a foreign body X-ray be taken in the OR.

The film should encompass the entire operative field and the radiologist should be advised that the film was taken specifically to identify a RFB. The radiologist’s interpretation should be conveyed to the surgeon and the surgeon should personally inspect the film to confirm that the entire operative field is examined by the X-ray and to confirm the absence of any FB. Additional films are not uncommonly required to cover the entire field. 

Creating a Culture of Safety in the OR

A culture of patient safety in the OR can be implemented by system processes but it must be implemented and practiced by the dedicated members of the surgical team. Judgmental and technical errors may occur, but can be minimized through education, training, proper credentialing and the implementation of “crew resource management” wherein all members of the surgical team are not only permitted and encouraged, but required, to identify any potential issues that may negatively impact the patient.

Reduce surgical errors and promote patient safety by:

• Implementing a surgical checklist
• Avoiding distractions
• Communicating effectively
• Recognizing the critical important of the surgical count
• Routinely performing a cavity search
• Confirming the adequacy of any foreign body film(s)
• Recognizing that all members of the surgical team are consummate professionals working toward a common goal.

The fact that we are still discussing this issue proves that we can, and must, do better.

References

[1] Kim FJ, da Silva RD , Gustafson RD, Nogueira L, Harlin T and Paul DL. Current issues in patient safety in surgery: a review. Patient Safety in Surgery (2015) 9:26 (Available at: https://doi.org/10.1186/s13037-015-0067-4)

[2] Forsyth KL, D’Angelo A, Cohen EM, and Pugh CM. Improving Clinical Performance by Analyzing Surgical Skills and Operative Errors, in Surgical Patient Care: Improving Safety, Quality and Value, Sanchez JA, Barach P, Johnson JK, and Jacobs JP, Eds. Springer International Publishing, Switzerland, 2017.

[3] Joint Commission Online, March 13, 2019. Available at: https://www.jointcommission.org/assets/1/23/JC_Online_March_13.pdf (last accessed May 13, 2019).

[4] Adverse Health Events in Minnesota 15th Annual Public Report Annual Report March 2019. Available at https://www.health.state.mn.us/facilities/patientsafety/adverseevents/docs/2019ahereport.pdf (Last accessed May 13, 2019)

[5] Wrong Site Surgery Statistics, The Sullivan Group (2019). Available at: https://blog.thesullivangroup.com/wrong-site-surgery-statistics (last accessed May 13, 2019)

[6] Retained Surgical Sponge: Never Means NEVER! The Sullivan Group (2019). Available at: https://blog.thesullivangroup.com/retained-surgical-sponge-never-means-never (last accessed May 13, 2019)

[7] Stawicki SPA, Moffatt-Bruce SD, Ahmed HM, Harry L Anderson III HL, MD, FACS, Balija TM, Bernescu I, Chan L, Chowayou L, Cipolla J, Coyle SM, Gracias VH, Gunter OL, Marchigiani R, Martin ND, Patel J, Seamon MJ, Vagedes E, Ellison EC, Steinberg SM, and Cook CH. Retained Surgical Items: A Problem Yet to Be Solved. J Am Coll Surg 2013; 216:15e22.

[8] Gawande AA, Studdert DM, Orav EJ, Brennan TA, and Zinner MJ. Risk Factors for Retained Instruments and Sponges after Surgery. N Engl J Med 2003;348:229-35

[9] Lincourt AE, Harrell A, Cristiano J, Sechrist C, Kercher K, and Heniford BT. Retained Foreign Bodies After Surgery. Journal of Surgical Research 138, 170–174 (2007)

[10] Moffatt-Bruce SD, Cook CH, MD, Steinberg SM, and Stawicki SP. Risk factors for retained surgical items: a meta-analysis and proposed risk stratification system. Journal of Surgical Research 190(2), 429-36 (2014)

[11]  Steelman VM, Shaw C, Shine L, and Hardy-Fairbanks AJ.  Unintentionally Retained Foreign Objects: A Descriptive Study of 308 Sentinel Events and Contributing Factors.  The Joint Commission Journal on Quality and Patient Safety2019;45:249–258.

[12] Laners, R. Reducing Surgical Errors: Implementing a Three-Hinge Approach to Success. AORN J 101 (June 2015) 657-665.

[13] AORN. Guideline at a Glance: Retained Surgical Items. AORN J. 2016 Nov;104(5):474-477

[14] Wallace SC. Pennsylvania Patient Safety Authority. Retained Surgical Items: Events and Guidelines Revisited. Pa Patient Saf Advis 2017 Mar;14[1]:27-35.

[15] American Psychological Association. “Multitasking: Switching Costs” available at: https://www.apa.org/research/action/multitask (Last accessed May 17, 2019)