|Year : 2016 | Volume
| Issue : 1 | Page : 1-4
What's New in Academic Medicine? Retained surgical items: Is “zero incidence” achievable?
Michelle C Nguyen, Susan D Moffatt-Bruce
IJAM Principal Editors, Department of Surgery, Wexner Medical Center, The Ohio State University, Columbus, Ohio, USA
|Date of Web Publication||2-Jun-2016|
Michelle C Nguyen
IJAM Principal Editors, Department of Surgery, Wexner Medical Center, The Ohio State University, Columbus, Ohio
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Nguyen MC, Moffatt-Bruce SD. What's New in Academic Medicine? Retained surgical items: Is “zero incidence” achievable?. Int J Acad Med 2016;2:1-4
|How to cite this URL:|
Nguyen MC, Moffatt-Bruce SD. What's New in Academic Medicine? Retained surgical items: Is “zero incidence” achievable?. Int J Acad Med [serial online] 2016 [cited 2020 Jun 7];2:1-4. Available from: http://www.ijam-web.org/text.asp?2016/2/1/1/183330
Retained surgical items (RSIs) are designated as “never events” or sentinel events that are considered to be totally preventable. A sentinel event is defined as a patient safety event that reaches a patient and results in death, permanent harm, or severe temporary. In 1996, the Joint Commission adopted a formal Sentinel Event Policy, which details serious adverse events and their respective prevention strategies. RSI incidence was added to the Sentinel Event Policy on June 2005, and its incidence reached a peak of 188 cases in 2011, surpassing the incidence of wrong-patient, wrong site, and wrong procedure events which were the most frequently reported events in 2008 and 2009. These numbers only represent a small proportion of actual events given the voluntary nature of reporting to The Joint Commission. The true incidence of RSIs is unknown, however, estimates range from one in every 1000–1500 abdominal procedures to one in every 8000–18,000 inpatient procedures annually in the USA., The most common RSIs include soft goods (sponges and towels), un-retrieved device components or fragments, stapler components, parts of laparoscopic trocars, guide wires, catheters, and pieces of drains, needles and other sharps, and instruments (most commonly malleable retractors). RSIs can lead to complications including pain, sepsis, intestinal obstruction, prolonged length of stay, and rarely death.,, Not only do RSIs harm the patient, but they also add significantly to the average total cost of caring for the patient ranging up to $200,000 or more per incident which covers legal defense, indemnity payments, and surgical costs not reimbursed by the Centers for Medicare and Medicaid Services.
The alarming continuation of RSIs has led to increased research efforts aimed at identifying their associated risk factors in hopes of risk mitigation. RSI risk factors identified by four major studies include operation performed on an emergent basis, unexpected change in operation, longer duration of operation, intraoperative complications, number of surgical teams, total number of major procedures, intraoperative blood loss, body-mass index, and incorrect count recorded.,,, However, these studies demonstrate discordance of significance for several of these risk factors and further large, prospective, multicenter studies are necessary to establish their true significance. Interestingly, one study identified a novel and possibly beneficial influence of resident participation on reducing RSI risk, suggesting that the attentive and inquisitive nature of trainees can lead to increased clinical outcomes.
The risk profile for RSIs seems to demonstrate an association between demographic and clinical factors, the majority of which are nonmodifiable clinical and patient events. This highlights the importance of targeted efforts toward identified high-risk populations by way of systematic, team-based approach to intraoperative patient safety. A study by Stawicki et al. demonstrated that very few of RSI cases involve isolated human error. In fact, the majority of cases involve team-based or system errors where intraoperative safety omissions or variances (SOVs) occurred. These SOVs include error involving insufficient safety cross-checks/redundancy; error involving lack of safety knowledge/education; and error in safety verification, documentation, or communication. Most operations complicated by RSIs were found to involve more than two SOVs. These findings are consistent with the most common root causes of RSIs identified from The Joint Commission sentinel event data which include the absence of policies and procedures, failure to comply with existing policies and procedures, problems with hierarchy and intimidation, failure in communication with physicians, failure of staff to communicate relevant patient information, and inadequate or incomplete education of staff.
Likewise, the operating room environment can increase the risk of error during the counting process. Communication failures, distractions from multiple competing interests, pressure for increased productivity, and lack of sufficient personnel are all factors that may contribute to errors in the surgical count. In addition, in the event of a count and subsequent recount, the chance that counts will not match is substantial, representing inherent potential for human error in the process. The accuracy of instrument/sponge counts are also affected by the complexity of the surgery, emergent or urgent nature of the surgery, and the surgical team's fatigue and workload.,,, Truly understanding the sacrifice point between safety and efficiency is not always easy and establishes a tension within every operative environment.
The identified RSI risk factors highlight the effect of team and human error which comprise a network of systematic errors that can be specifically targeted for improvement by way of team training. Specific team training strategies using crew resource management theory have been developed and widely adopted into the health care system and have been shown to be feasible and impactful in reducing operative mortality., Perioperative team training in its current form relies heavily on the use of checklists. In 2009, the World Health Organization issued a worldwide recommendation for the use of its surgical safety checklist in all perioperative procedures as an instrument for improvement of communication, teamwork, and safety culture in the operating room. The three-part checklist includes specific times of the operation in which anesthesia and surgery are interrupted. These times are immediately before induction of anesthesia (sign-in), immediately before skin incision (time-out), and immediately after skin closure (sign-out). The portion affecting surgical counts lies within the “sign-out” process during which other major concluding points are checked. This process ensures the correctness of final sponge and instrument count prior to the conclusion of the operation but relies heavily on institutions to implement specific protocols for the counting process.
Guidelines have been provided by the American College of Surgeons (ACS), the association of perioperative registered nurses (AORN), and The Joint Commission. These guidelines recommend counting all sponges prior to the procedure, prior to closure of a cavity, prior to wound closure, at skin closure, and at the time of permanent relief of either the scrub person or circulating nurse. In addition, best practices have been created by the AORN with the support of ACS [Figure 1].,
|Figure 1: Association of perioperative registered nurses best practices for preventing retention of a foreign object|
Click here to view
Traditionally, prevention of RSIs relied on surgeons and operating room staff to perform “cavity sweeps” and manual counting protocols; both of which are prone to human error despite the existence of counting procedures in most hospitals. Surgical teams routinely rely on discrepancies in the surgical count procedure to screen for the presence of a potential RSI. However, current practices for counting sponges have a 10–15% error rate and 80% of retained sponges occurred when the counts were reported to be correct., Human error has been shown to be a major contributor to count discrepancy due to inaccurate addition, incorrect documentation, or miscounting. Not surprisingly, incorrect sponge counts have been associated with up to 20-fold increased risk of RSI and alarmingly, one study demonstrated a 17% incident of cases that were continued to completion despite incorrect counts.,
As these data suggest, manual counting continues to be unreliable and may not prevent RSIs despite the development of best practice protocols. In addition to understanding human factors and strict adherence to standardized counting procedures, additional strategies such as radiographic screening and use of assistive technology have been proposed to further mitigate the incidence of RSIs. Routine postoperative screening radiographs have been suggested, however, their sensitivity is limited in detecting sponges and needles , and may require higher resolution radiographs in dedicated imaging areas for improved sensitivity. Currently, standard practice of some institutions is to obtain postoperative radiographs only in cases of count discrepancy or when indicated as recommended by the ACS.
Other assistive technologies include radio-frequency (RF) detectable sponge systems, RF identification-detectable sponge systems, and bar-coded systems have been studied and been shown to be effective. However, the cost-benefit analysis of routine use of postoperative radiographs and these technologies need to be further elucidated before widespread implementation. The introduction of disruptive technology is not without its price.
When serious reportable events (SREs) occur, they impose a difficult situation for the health care provider. Following an error, providers often feel embarrassed of their mistake and try to conceal or shift responsibility to another source. Providers are often unaware that mistakes rarely occur as a result of single human error but rather as a result of team/system error. This shaming and blaming tendency prevents high rates of reporting and disclosure. Likewise, confusion around the differences in reporting and disclosure and their mechanisms may lead to underreporting as well [Figure 2]. In addition, providers may fear career-threatening disciplinary actions and possible malpractice litigation and liability.
|Figure 2: Error communication strategies in the health care setting; differentiating reporting and disclosure|
Click here to view
In the last decade, organizations have shifted toward a culture of patient safety by enabling reporting mechanisms and even rewarding those who report. Yet, creating a nonpunitive environment is a work in progress even within organizations with an established culture of safety. Disclosure policies have been implemented by the Veterans Affairs (VA) system and have led to increased reporting and identification of systematic actionable targets for patient safety improvement efforts. Other systems around voluntary error reporting have been built on the VA reporting system.
Currently, reporting of RSIs to The Joint Commission is voluntary, and the incidence reported likely only represents a small portion of actual events. Furthermore, requirements for mandated reporting to regulatory bodies vary from state to state. The National Quality Forum, which is a convention of committees that work together to set standards and endorse quality measures used to drive improvement and create accountability, has developed and endorsed a set of SREs under which includes unintentionally retained foreign objects in all applicable settings. The purpose of the National Quality Forum-endorsed list of SREs is to facilitate uniform and comparable public reporting to enable systematic learning across healthcare organizations and systems. Although these organizations exist to monitor patient safety events, individual health care institutions need to also embrace the patient safety culture and develop standardized reporting processes. To sustain a collaborative effort in improving patient safety, error-reporting strategies should include processes in identification, sentinel event processing with root cause analyses, and subsequent appropriate revisions in protocol as necessary so that system improvements are consistent with error patterns.
Can RSIs be completely eliminated? Absolutely. When this will be achieved is a different question but the quest for perfection is one that is reasonable. RSIs are appropriately classified as “never events” because they should be totally intolerable and preventable. The endorsement of RSIs as an SRE along with widespread acceptance of team training, protocol development, and checklist implementation has led to a steady decline in incidence with 188 cases reported in 2011 to 116 cases reported in 2015. There is still much work left to obtain zero incidences but the surgical community should be optimistic about the improvements made thus far. National initiatives around mandatory reporting should be considered to track true incidences to understand trends and actual failure modes that are modifiable. With maximum reporting, continued development and improvement of counting procedures, acceptance of new assistive technologies in the counting process, and engagement of stakeholders from multidisciplinary levels, health systems can work toward a safer surgical environment for patients by reducing the occurrence of RSIs to absolute zero.
| References|| |
Stawicki SP, Moffatt-Bruce SD, Ahmed HM, Anderson HL 3rd
, Balija TM, Bernescu I, et al.
Retained surgical items: A problem yet to be solved. J Am Coll Surg 2013;216:15-22.
Sentinel Event Data – Event Type by Year, 1995-2015. Available from:
. [Last accessed on 2016 Mar 30].
Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. Risk factors for retained instruments and sponges after surgery. N Engl J Med 2003;348:229-35.
Gonzalez-Ojeda A, Rodriguez-Alcantar DA, Arenas-Marquez H, Sanchez Perez-Verdia E, Chavez-Perez R, Alvarez-Quintero R, et al.
Retained foreign bodies following intra-abdominal surgery. Hepatogastroenterology 1999;46:808-12.
NoThing Left Behind ®
: A National Surgical Patient-Safety Project to Prevent Retained Surgical Items. Available from: http://www.nothingleftbehind.org/
. [Last accessed on 2016 Mar 30].
Jackson S, Brady S. Counting difficulties: Retained instruments, sponges, and needles. AORN J 2008;87:315-21.
Moffatt-Bruce SD, Cook CH, Steinberg SM, Stawicki SP. Risk factors for retained surgical items: A meta-analysis and proposed risk stratification system. J Surg Res 2014;190:429-36.
Stawicki SP, Evans DC, Cipolla J, Seamon MJ, Lukaszczyk JJ, Prosciak MP, et al.
Retained surgical foreign bodies: A comprehensive review of risks and preventive strategies. Scand J Surg 2009;98:8-17.
Regenbogen SE, Greenberg CC, Resch SC, Kollengode A, Cima RR, Zinner MJ, et al.
Prevention of retained surgical sponges: A decision-analytic model predicting relative cost-effectiveness. Surgery 2009;145:527-35.
Lincourt AE, Harrell A, Cristiano J, Sechrist C, Kercher K, Heniford BT. Retained foreign bodies after surgery. J Surg Res 2007;138:170-4.
Stawicki SP, Cook CH, Anderson HL 3rd
, Chowayou L, Cipolla J, Ahmed HM, et al.
Natural history of retained surgical items supports the need for team training, early recognition, and prompt retrieval. Am J Surg 2014;208:65-72.
Gibbs VC, Coakley FD, Reines HD. Preventable errors in the operating room: Retained foreign bodies after surgery – Part I. Curr Probl Surg 2007;44:281-337.
Best practices for preventing a retained foreign body. AORN J 2006;84 Suppl 1:S30-6.
Greenberg CC, Regenbogen SE, Lipsitz SR, Diaz-Flores R, Gawande AA. The frequency and significance of discrepancies in the surgical count. Ann Surg 2008;248:337-41.
Egorova NN, Moskowitz A, Gelijns A, Weinberg A, Curty J, Rabin-Fastman B, et al.
Managing the prevention of retained surgical instruments: What is the value of counting? Ann Surg 2008;247:13-8.
Dunn EJ, Mills PD, Neily J, Crittenden MD, Carmack AL, Bagian JP. Medical team training: Applying crew resource management in the Veterans Health Administration. Jt Comm J Qual Patient Saf 2007;33:317-25.
Moffatt-Bruce SD, Hefner JL, Mekhjian H, McAlearney JS, Latimer T, Ellison C, et al.
What is the return on investment for implementation of a crew resource management program at an academic medical center? Am J Med Qual 2015. pii: 1062860615608938.
WHO's patient-safety checklist for surgery. Lancet 2008;372:1.
Statement on the prevention of retained foreign bodies after surgery. Bull Am Coll Surg 2005;90:15-6.
Tips for reducing retained surgical items. Same Day Surg 2009;33:91-2.
Cima RR, Kollengode A, Garnatz J, Storsveen A, Weisbrod C, Deschamps C. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg 2008;207:80-7.
Kranzfelder M, Zywitza D, Jell T, Schneider A, Gillen S, Friess H, et al.
Real-time monitoring for detection of retained surgical sponges and team motion in the surgical operation room using radio-frequency-identification (RFID) technology: A preclinical evaluation. J Surg Res 2012;175:191-8.
Weeks WB, Bagian JP. Developing a culture of safety in the veterans health administration. Eff Clin Pract 2000;3:270-6.
Wolf ZR, Hughes RG. Error reporting and disclosure. In: Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): AHRQ; 2008.
Wu AW, Cavanaugh TA, McPhee SJ, Lo B, Micco GP. To tell the truth: Ethical and practical issues in disclosing medical mistakes to patients. J Gen Intern Med 1997;12:770-5.
Force MV, Deering L, Hubbe J, Andersen M, Hagemann B, Cooper-Hahn M, et al.
Effective strategies to increase reporting of medication errors in hospitals. J Nurs Adm 2006;36:34-41.
Fein S, Hilborne L, Kagawa-Singer M, Spiritus E, Keenan C, Seymann G, et al
. A conceptual model for disclosure of medical errors. Concepts and Methodology. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation. Vol. 2. Rockville (MD):AHRQ; 2005.
Flink E, Chevalier CL, Ruperto A, Dameron P, Heigel FJ, Leslie R, et al
. Lessons learned from the evolution of mandatory adverse event reporting systems. Implementation Issues. In: Henriksen K, Battles JB, Marks ES, Lewin DI, editors. Advances in Patient Safety: From Research to Implementation. Vol. 3. Rockville (MD):AHRQ; 2005.
National Quality Forum (NQF). Serious Reportable Events in Healthcare-2011 Update: A Consensus Report. Washington, DC: National Quality Forum (NQF); 2011.
[Figure 1], [Figure 2]