Best practices in preventing retained foreign objects
- 1. FromSafetyNet • aorn journal • JULY 2006, VOL 84, SUPPL 1S30 Best Practices for Preventing a Retained Foreign Body At a large academic facility, a female patient was scheduled to under- go a vaginal repair. In addition to the assigned perioperative team, a new surgical technologist in orientation and a surgical resident scrubbed in on the case. Two student nurses assigned to observe the procedure also were in the room. The surgeon was teaching and explaining the procedure in detail to the nursing students, resident, and surgical technologist as he performed the surgery. The RN cir- culator noted a count discrepancy during the wound closure count. The surgeon ordered the patient x-rayed and identified a retained radiopaque sponge along the left margin of the vaginal wall. Following the positive x-ray, the surgeon removed a portion of the closing sutures and retrieved the retained sponge. The patient remained anesthetized and had not been transported from the OR when the incorrect count was noted and the x-ray taken. The periop- erative team members followed the facility’s protocol for incorrect counts, and the error was corrected in a timely manner. Following this incident, the surgical staff member involved in the procedure discussed factors contributing to the retained sponge with the peri- operative team members. They concluded distraction was a primary cause leading to this near-miss occurrence. An RN circulator involved in an exploratory laparotomy was in the process of delivering additional laparotomy sponges to the sterile field. Intending to provide two packages totaling 10 sponges, the circulator presented the only pack available to the scrub. The circulating nurse noted on the count sheet that two packs (ie, 10 sponges) were added to the sterile field and proceeded to leave the room to secure the additional five sponges from the supply area. Upon returning to the room, the circulating nurse became distract- ed by another request from the scrubbed team members and did not deliver the second package of sponges to the sterile field. At the time of the closing sponge count, five laparotomy sponges were missing. An abdominal x-ray was taken but revealed no evi- dence of a retained foreign body. After receiving the negative report, the surgical team members discovered that the second pack- age of sponges had never been delivered to the sterile field. An open surgical technique was used to place a small radiopaque gauze sponge into the incision site to control bleeding during an endoscopic saphenous vein harvesting. There are increasing reports of these endoscopic incisional sponges being retained in wounds after the leg incisions are closed. Despite the minimally invasive technique and small incision size, multiple occurrences have been associated with this practice. Case Study 1 Case Study 2 Case Study 3 S30--36-Supp2_Counts 6/26/06 11:33 AM Page S30
- 2. S31aorn journal • JULY 2006, VOL 84, SUPPL 1 Case Study 4 Perioperative team members in a rural location do not regularly perform surgical sponge counts and also omit counts of sharps and other miscellaneous items. Although counts are incomplete or not performed, RN circulators document on the permanent patient care record that all counts are performed and correct. This process is not isolated to select surgical procedures but occurs throughout the perioperative environment. The perioperative staff members openly state that they do not embrace the practice of routine surgi- cal and procedural counts. H istorically, counts began as a process to prevent the loss of marine sponges during surgical procedures and evolved to routinely include instruments.1 The necessity to establish a consistent practice for surgi- cal counts was recognized by the early leaders of AORN, and the “Standards for sponge, needle, and instrument pro- cedures” was first published in the 1976 AORN Journal, two years before the Association collated practice statements into a bound text.2 Since that time, the standard to conduct surgical counts has become an international practice. Error-Prone Process Staff members at AORN frequently receive inquiries about proper count procedures. As in the case studies above, many perioperative nurses seek to understand when, how, or why counts must or should be performed in a variety of surgical and procedural interventions. Many inquiries question the efficacy of performing counts or describe a work culture hostile to ques- tioning careless practices. Still others express distress about approaching col- leagues about count discrepancies or the difficulties associated with performing counts during complex procedures.1 AORN’s “Recommended practices for sponge, sharp, and instrument counts” was developed to address when counts should occur, the items that should be counted, the types of proce- dures requiring counts, considerations for the development of policies and pro- cedures addressing counts, and the associated criteria for performing a count. These recommended practices embrace the legal implication that retention of a foreign object in a patient defines negligence.3 Legal jurisdiction focuses exclusively on the negligence of the act of a retained item and not on the necessity to conduct a surgical count, or who should be responsible to perform a count.4 Despite the availability of count rec- ommendations, stories circulate of retained foreign bodies and periopera- tive clinicians found negligent on the grounds of inadequate count practices. Furthermore, following the recom- mended practices for surgical counts does not guarantee relief from inaccu- racies in the count process. Reviews of intraoperative documentation, includ- ing facility count sheets, reflect the occurrence of “correct counts” when in fact surgical team members have unin- tentionally left surgical sponges, instru- ments, or other items (eg, towel, catheter tip, sharp) in the patient. Considered by perioperative clinicians and legal counsel to be avoidable, the cause for these discrepancies remains unknown. This phenomenon has been studied without conclusive evidence to identify the associated human- and sys- tems-related factors involved.5 Human-error literature associates error-prone processes with cognitive lapses or slips arising from repetitive or routine functions. Influenced by the environment, cognitive disconnects fre- quently result in unconscious, “non- choice” responses, especially when linked to habitual processes.6 The redun- dancy of surgical counts, combined with the interruptions and distractions occur- ring in perioperative care settings, places counting practice at risk for error. The process of counting is only one factor Improving Outcomes Case Study 4 S30--36-Supp2_Counts 6/26/06 11:33 AM Page S31
- 3. • aorn journalS32 JULY 2006, VOL 84, SUPPL 1 involved in the prevalence of retained objects. The actions of the surgeon, surgeon’s assistant, and scrub personnel also can contribute to error-prone scenarios evolving from cognitive and behavioral practice variations. Though the exact details of why counting errors occur are not fully understood, research has identified emergency situations, unexpected changes in the procedure, and patient obesity as specific situations that have a higher predisposition for errors or near misses.5 Setting the Standard The discipline of nursing is guided by professional practice standards, influ- enced by specialty association recom- mendations, and governed by regulatory and consumer safety initia- tives. Nurses are bound by an ethical code to advocate for and protect the patients under their charge. When faced with discrepancies in the provision of appropriate care, the nurse is obligated to call attention to the situation and implement the corrective actions neces- sary to promote the well-being of the patient. Professional accountability requires the nurse to act responsibly in the interest of patient safety, including monitoring personal competence and being responsible for the quality of care provided.7 Perioperative RNs are bound by this nursing ethic to place the patient first and seek to establish a patient care environment conducive to healing that is grounded in evidenced-based practice. Perioperative nurses care for the patient at his or her most vulnerable time and recognize the significance of their pres- ence on the patient’s outcome. The peri- operative nurse also understands the importance of collaborating with other members of the health care team to establish practice guidelines to protect the patient during operative and inva- sive interventions. Both AORN and the American College of Surgeons support the following recommendations to prevent the retention of a foreign body: • consistently performing surgical counts according to national standards and facility policy; • promoting an environment that is focused on, and attentive to, the patient’s perioperative care; • using only x-ray detectable sponges, towels, miscellaneous items, and instruments in the surgical wound; • conducting a methodical wound exploration before wound closure and whenever a count discrepancy is noted; • employing radiographic or other technology (eg, bar coding, radio- frequency detection) as needed to ensure that all potential foreign bodies have been removed from the surgical site; • documenting the outcomes of the surgical count, items intentionally used for packing, and actions taken to rectify a count discrepancy; • documenting the justification for omission of counts in life- threatening situations; • providing resources (ie, equipment and personnel) to support safe practices to prevent retention of foreign objects; • developing and reviewing count policies and procedures through a collaborative process to promote consistency in practice across disciplines; and • making count policies and proce- dures readily available in the practice setting.3,8 Additionally, AORN’s “Recommended practices for sponge, sharp, and instru- ment counts” offers guidance in the progressive management of surgical counts. The following points highlight important practice recommendations. • Sponges should be counted on all procedures in which the possibility exists that a sponge could be retained. • Sharps and other miscellaneous items should be counted on all procedures. S30--36-Supp2_Counts 6/26/06 11:33 AM Page S32
- 4. S33aorn journal • JULY 2006, VOL 84, SUPPL 1 • Instruments should be counted for all procedures in which the likelihood exists that an instrument could be retained. • Initial counts should be performed to establish a baseline for subsequent counts, including minimally invasive procedures. • Counts should be performed before the procedure, before wound closure, at the time of permanent relief of the scrub person or registered nurse circulator, and at other times during the procedure as defined by AORN recommended practices. • Additional measures for investigation, reconciliation, documentation, and prevention of retained surgical items should be taken. • Sponge, sharp, and instrument counts should be documented on the patient’s intraoperative record by the registered nurse circulator.3 Should a discrepancy be noted during the count period, the perioperative team should respond in the following ways. • Report the discrepancy to the surgeon and surgical team members. • Suspend the procedure, if the patient’s condition permits. • Perform a manual exploration of the surgical wound. • Visually inspect the surrounding surgi- cal field, including the floor, kick buck- ets, and linen and trash receptacles. • Perform an intraoperative x-ray and have it read by a radiologist if the patient’s condition permits, if the patient is unstable, an x-ray should be taken as soon as possible. • Document all measures taken and their outcomes on the patient’s record. • Report the incident following facility policy. • Perform a review of the incident or near miss for cause, effect, and prevention.3 Additional documentation of surgical counts should include • the types of counts (ie, sponges, sharps, instruments, miscellaneous items) and the number of counts performed; • names and titles of personnel performing the counts; • results of surgical item counts; • notification of the surgeon; • instruments intentionally remaining in the patient or sponges intentionally retained as packing; and • justification if counts are not per- formed or completed as prescribed by policy, including situations of extreme life or loss of limb emergency.3 Perioperative team members must be committed to providing safe patient care and implementing strategies to promote the desired outcome of “no item left behind” in surgical cavities. Collaborative processes and integration of evidence- based practices will help to improve the patient’s likelihood of an uneventful surgical or procedural intervention. Analysis SafetyNet submissions validate the inadequacies of human function as related to surgical counts. Common themes evident in these reports include • distraction or inattention to the practice environment, • communication disruptions, • disregard for practice standards, and • documentation of counts when not performed. Analysis of near misses will assist surgical team members to gain a better understanding of what may have caused the event. Asking a series of pointed questions will help clarify which factors may have contributed to the near miss. S30--36-Supp2_Counts 6/26/06 11:33 AM Page S33
- 5. • aorn journalS34 JULY 2006, VOL 84, SUPPL 1 Questions that could be explored to help understand the contributing factors for this near miss include the following. • Did the skill level of several of the staff contribute to the event? • Did the teaching done by the sur- geon impact the ability of some of the team members to focus on their responsibilities related to prevent- ing a retained foreign body? • Did the surgical team members receive adequate orientation to sup- port their obtaining competency in performing surgical counts? Distractions caused by conversations in the room (eg, personal, educational) may lead to communication failures between the surgical technologist and RN circulator regarding the number of sponges placed in the wound. The 2004 Institutes of Medicine report, Keeping Patients Safe: Transforming the Work Environment of Nurses, associates dis- traction and multi-tasking with com- promised delivery of safe patient care.9 Inherent within the perioperative environment are extraneous stimuli resonating from assorted patient care equipment in the form of monitoring signals, equipment activation, and cau- tionary alarms. This is compounded by the simultaneous conversations of the surgical team members to communi- cate patient status, request needed supplies, provide education, relieve stress, and facilitate socialization. Specific to this scenario, it is pre- sumed that the surgical team mem- bers did not demonstrate vigilance in monitoring the activities of staff members and observers who may be unfamiliar with department routines, nor was an active process identified to validate the presence and numbers of items within the surgical wound. Errors and near misses resulting from distraction-prone environments war- rant special attention and investiga- tion (eg, root cause analysis) to identify contributing factors, risks, and preventive measures.3 Following the analysis, this facility gathered the surgical team members to evaluate the near miss. The surgical team members acknowledged that the count process they followed proved to be a safety mechanism that protected the patient, and they accurately iden- tified distraction as the cause of breakdown in communications. To prevent a future occurrence, a multi- disciplinary plan also should be devel- oped and implemented by the department. This plan should include cautionary insights when a learning environment is an added component of the day. Questions that could be explored to help understand the contributing factors for this near miss include the following. • Did the RN circulator follow the organizational procedure for docu- mentation of sponge counts? • How prevalent is the practice of documenting the number of sponges before the count has actu- ally taken place? • What action should be taken if it is determined that this was not an isolated event of documentation of the number of sponges before the count has occurred? This scenario highlights the concern raised by pre-documentation of patient care. Documenting processes before they are implemented should never occur because it may open clini- cians to unintended omissions and dis- crepancies in actual care provided. Environmental distraction will compli- cate the clinician’s ability to multi-task activities while employing “mental lists” to compile and expedite patient care. In attending to the immediate needs of the scrubbed team members, this circulator’s intentions were inter- rupted and the previous notations in the count documentation negated. Case Study Analysis 1 Case Study Analysis 2 S30--36-Supp2_Counts 6/26/06 11:33 AM Page S34
- 6. S35aorn journal • JULY 2006, VOL 84, SUPPL 1 Questions that could be explored to help understand the contributing factors for this near miss include the following. • What measures can be implement- ed to help prevent retention of sponges on minimally invasive endoscopic procedures? • Would a change in practice to use larger sponges eliminate the risk of retained sponges? The potential hazards related to mini- mally invasive procedures can be over- looked. As demonstrated in this situation, transferring traditional prac- tices to endoscopic procedures without implementing safeguards to prevent erroneous actions can have unfavorable consequences. Perioperative clinicians should remain aware of the placement of surgical sponges when incisions are large enough to engulf a sponge. Endoscopic vein harvesting customari- ly begins with a small 2 cm incision, with the underlying tissue spaces being enlarged through blunt dissection to accommodate endoscopic equipment.10 Sponges inserted into the wound and used to control bleeding may become displaced along the endoscopic path- way. Once saturated with blood, the sponge is more difficult to distinguish from anatomical structures. AORN’s “Recommended practices for sponge, sharp, and instrument counts” reports the frequency of retained objects in extremities and directs perioperative nurses to imple- ment “alternative or additional safety measures for special circumstances.”3 The size of the radiopaque sponge and incision should be a decisive factor in determining if a surgical count should be performed. Facility policy also should reflect these special considera- tions in providing guidance to the perioperative nurse. Questions that could be explored to help understand the contributing factors for this near miss include the following. • Do the perioperative team members understand the standard of care they would be held to in the event that a patient is injured due to a retained foreign body? • Do the perioperative team members fully understand their duty to pro- tect their patients from the poten- tial for unnecessary harm? • Is there an organizational policy and procedure that addresses the requirements for surgical and pro- cedural counts? • Do the perioperative team members understand the risk and ethical implications of documenting counts that were not performed? • What are the underlying issues related to the perioperative staff members not supporting the prac- tice of routine surgical and proce- dural counts? It is unknown whether this facility has existing policies and procedures govern- ing organization-wide surgical count practices and any reportable incidence of retained foreign body. It is assumed, from the limited description, that the perioperative team members comfort- ably trust one another and, in doing so, collectively agree to alter accepted prac- tice standards, possibly to save time during procedures. While the previous statement is assumed, it is clear that the RNs are involved in the unethical prac- tice of falsifying patient care records. Regardless of the rationale used to justify unacceptable activities, profes- sional staff members are obligated to protect the patient from unnecessary harm. This lack of self-discipline and disregard for national practice stan- dards may lead to a decline in profes- sional competence and foster a culture of unsafe practices. Personal attitude and motivation have been linked to and are influenced by organization policy, management systems, and life choices.11 The actions of the staff members also reflect weak department or organiza- tional leadership contributing to the lackadaisical approach to professional practice guidelines. Case Study Analysis 4 Case Study Analysis 3 S30--36-Supp2_Counts 6/26/06 11:33 AM Page S35
- 7. • aorn journalS36 JULY 2006, VOL 84, SUPPL 1 • Always follow facility guidelines for count procedures. • Periodically review established policies for emerging evidence of best prac- tices for counts in relation to new surgical or procedural interventions. • Minimize distractions whenever counts are being performed. • Remain attentive to the procedure and account for items placed in body cavities. • Perform a count before closing body cavities that could retain items used during the procedure. • Address inappropriate practices that may lead to patient harm. • Documentation must be accurate and reflect actual care given. LESSONS LEARNED 1. S C Beyea, “Counting instruments and sponges,” AORN Journal 78 (August 2003) 290-294. 2. “Standards for sponge, needle, and instrument procedures,” AORN Journal 23 (May 1976) 971-973. 3. “Recommended practices for sponge, sharp, and instrument counts,” in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2006) 459-468. 4. E K Murphy, “Operating room records, counts cause concern,” (OR Nursing Law) AORN Journal 51 (June 1990) 1606-1612. 5. A A Gawande et al, “Risk factors for retained instruments and sponges after surgery,” The New England Journal of Medicine 348 (16 January 2003) 229-235. 6. J Reason, Human Error (New York: Cambridge University Press, 1990). 7. American Nurses Association, Code of Ethics for Nurses With Interpretive Statements (Washington, DC: ANA, 2001). 8. “Statement on the prevention of retained foreign bodies after sur- gery,” American College of Surgeons, http://www.facs.org/ fellows_info/statements/st-51.html (accessed 15 May, 2006). 9. Institute of Medicine, Keeping Patients Safe: Transforming the Work Environment of Nurses (Washington, DC: National Academies Press, 2004). 10. P A Carpino et al, “Clinical benefits of endoscopic vein harvesting in patients with risk factors for saphenectomy wound infections undergoing coronary artery bypass grafting,” The Journal of Thoracic and Cardiovascular Surgery 119 (January 2000) 69-75. 11. J F Byers, S V White, eds, Patient Safety: Principles and Practices (New York: Springer Publishing Company, Inc, 2004) 34. Notes S30--36-Supp2_Counts 6/26/06 11:33 AM Page S36