MILITARY MEDICINE, 176, 6:702, 2011

Implementation of a Protocol to Reduce Occurrence of Retained Sponges After Vaginal Delivery

LCDR Monica A. Lutgendorf, MC USN; LCDR Lynnett L Schindler, MC USN; COL James B. Hill, MC USA (Ret); CART Everett F Magann, MC USN (Ret.); CART John D. O'Boyle, MC USN
ABSTRACT Background: Retained sponges (gossypiboma) following vaginal delivery are an uncommon occurrence. Although significant morbidity from such an event is unlikely, there are many reported adverse effects, including symptoms of malodorous discharge, loss of confidence in providers and the medical system, and legal claims. Objective: To report a protocol intended to reduce the occurrence of retained sponges following vaginal delivery. Methods: After identification of limitations with existing delivery room protocols, we developed a sponge count protocol to reduce occurrence of retained vaginal sponges. We report our experience at Naval Medical Center Portsmouth, a large tertiary care military treatment facility with our efforts to implement a sponge count protocol to reduce retained sponges following vaginal delivery. Conclusions: With appropriate pre-implementation training, protocols which incorporate post-delivery vaginal sweep and sponge counts are well accepted by the health care team and can be incorporated into the delivery room routine.

BACKGROUND
Retained sponges (gossypiboma) following vaginal delivery are rare adverse events. Although significant morbidity and mortality are unlikely, there has been a case report of maternal death following retained vaginal packing,' and patients often experience adverse effects including malodorous vaginal discharge, pain, and a loss of confidence in their medical providers and the health care system. In turn this can result in patient dissatisfaction and legal claims. The standard of care is not to leave a foreign body in a body cavity, and retained foreign bodies are currently reportable sentinel events to the Joint Commission. Retained sponges are estimated to occur in 1 in 9,000 to 19,0Ci0 procedures based on claims data; however, this is likely to be an underestimate.^ In a published review of closed case records over a 7-year period, 11 of 40 retained sponges were associated with spontaneous vaginal delivery in which no sponge count was performed.' In a retrospective case-control study, again reviewing claims data, 11 of 54 retained sponges were in patients undergoing closure of episiotomy incisions or vaginal tears after delivery in which sponge counts were omitted.^ Risk factors for retained foreign bodies include emergency surgical procedures, unplanned changes in procedures.

and increased body mass index.^ Efforts to prevent retained foreign bodies include sponge, sharp and instrument counts for all cases involving an open cavity, although sponge counts are not routinely done following vaginal deliveries. Additionally, simply counting instruments and sponges is not fool-proof. Up to 88% of retained foreign bodies were associated with a correct count, and there is no data regarding the reliability of such counts."* Other factors may also be important, including improved communication, among health care providers. Unintentional retained foreign objects following surgical procedures are serious events and led to the publication of a list of "Serious Reportable Events" by the National Quality Eorum in 2006. This list of events was published to increase accountability and awareness of important information about health care performance.' CONTEXT OF THE PROBLEM Our Labor and Delivery Unit manages approximately 4,000 deliveries per year. We are an academic teaching hospital, training interns, residents, and medical students in Obstetrics and Gynecology. The Labor and Delivery Unit is staffed by obstetrician/gynecologists and certified nurse-midwives who work closely with resident trainees. Retained sponges after vaginal delivery are an uncommon problem at our hospital, with 18 months and 6,000 deliveries between our previous retained vaginal sponges. Over the past 5 years, we have had 4 retained vaginal sponges following vaginal delivery, with a retained sponge rate of approximately 1/5,000 deliveries. At the time of our intervention, our protocol mandated a vaginal sweep following all vaginal deliveries. However, we found that this technique had the potential to be limited by patient discomfort or differences in provider experience and

Department of Obstetrics and Gynecology, Naval Medical Center Portsmouth, 620 John Paul Jones Circle, Portsmouth, VA 23708. The views expressed in this article are those of the authors and do not necessarily refieet the official policy or position of the Department of the Navy, Department of Defense, or the United States Government. The authors are military service members. This work was prepared as part of our official duties. Title 17 U.S.C. 105 provides that "Copyright protection under this title is not available for any work of the United States Government." Title 17 U.S.C. 101 defines a United States Government work as a work prepared by a military service member or employee of the United States Government as part ofthat person's official duties.

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Implementation of a Protocol to Reduce Gossypiboma Eollowing Vaginal Delivery

ASSESSMENT OF THE PROBLEM Development of the New Protocol The sponge count protocol was developed by a multidisciplinary team comprising staff and resident physicians and nurses. The root cause analysis of the retained vaginal sponge event revealed the limitations of the vaginal sweep. It was unclear exactly how such a sweep was performed and was found that a vaginal sweep could be seriously limited by patient discomfort or an inexperienced provider. The team was also sensitive to time constraints in a busy labor and delivery setting. The protocol implemented a sponge count before and after all vaginal deliveries. Providers were to initiate the sponge counts, and nurses were to verify and document the counts. If sponge counts were incorrect and a vaginal sweep failed to reconcile the count, then a more thorough examination of the vaginal cavity and an X-ray was to be performed. We anticipated potential barriers to acceptance from the health care team, including provider resistance to the additional task of counting sponges before delivery in a busy setting as this is usually a task performed by a surgical technologist in the operating room. Our protocol also changed the types of sponges used in the delivery cart. Previously, delivery carts were supplied with a package of plain (nonradiolabeled) 4 x 8 inch gauze sponges. With the new protocol, carts were stocked with 5 laparotomy sponges with radioopaque tails. The decision to change to laparotomy sponges was to simplify counting, allow for detection on X-ray, and provide a larger sponge that would be easier to identify after delivery, and be less likely to be overlooked on a vaginal sweep. To facilitate rapid visual counting, the sponges were to be laid out side by side on the delivery carts. Our protocol also recommends avoidance of the use of sponges in the vagina if possible. If sponges are placed in the vagina, only radioopaque sponges are to be used and the tail is to be left in view at all times. In addition, providers are asked to utilize a "call-out" to notify the nurse that a sponge has been placed in the vagina. After global training of providers and nurses on labor and delivery, we assessed compliance with the new policy by performing regular audits of charts to ensure that sponge counts were completed and documented appropriately. Audits We recommend performing regular audits of charts or electronic records to ensure appropriate documentation of compliance. If such audits reveal inadequate compliance and documentation, additional training may be required. Costs In our experience, the cost for modification of our delivery cart setup was minimal, with a cost increase of $10,000 annually. With 4,000 annual deliveries, this equates to an additional $2.50 per delivery.

RESULTS Since the new protocol, we have had over 10,500 deliveries without retained sponges. Our experience has been that this new protocol is simple and generally well accepted by the health care team. Initially, there were concerns that the new, larger laparotomy sponges would be difficult to use and that the sponge counts would be too "messy" and time consutning in our busy setting. However, we found that providers actually appreciate the new larger sized sponge, and they were easy to identify even in the post-delivery setting. The small number of sponges and the ability to perform a visual count also allowed for an efficient sponge count. Although we did not track the specific time required to complete the sponge count before and after delivery, we currently fij.d that this can be done quickly, usually within 60 seconds. On average, we have found that most deliveries use the initial 5 iaparotomy sponges provided on the standard delivery carts. In our institution, the post-partum hemorrhage rate is between 5 and 6%, and we have found that extra sponges were needed more often in the setting of post-partum hemorrhage or complex vaginal lacerations (also a rare occurrence). Thus, for most deliveries, the sponge count process is efficient and does not require the use of a large number of laparotomy sponges. In an effort to streamline the documentation process, we are currently revising our preprinted delivery records to further facilitate proper sponge count documentation. Electronic charting and documentation are also possible with this protocol. LESSONS AND CONCLUSIONS We have found that a sponge count during a vaginal delivery is a safe and effective method of reducing retained sponges. Since its introduction over 2 years ago, the sponge count protocol has been sustained in a busy labor and delivery setting with ongoing training of new providers and nurses working on labor and delivery. Our positive experiences with this protocol contributed to the Navy Medicine decision (NAVMED Policy 10-003) to include a vaginal delivery sponge count policy requiretnent among its quality and patient safety initiatives. We have found this protocol to be easy to implement in a busy labor and delivery setting and well accepted by the health care team. We feel that the multidisciplinary process improvement effort was critical in gaining staff acceptance of the new protocol and also feel that open communication between providers and nursing staff is an important part of reducing the occurrence of retained sponges in the delivery room. We believe that this protocol is effective in reducing the likelihood of a retained sponge following vaginal delivery; however, only cumulative experience over time with a large number of deliveries will validate its effectiveness. REFERENCES
1. McGregor JA, Soper DE, Lovell G, Todd JK: Maternal deaths a.s.sociated with Clostridium sordellii infection. Am J Obstet Gynecol 1989; 161: 987-95.

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Implementation of a Protocol to Reduce Gossypiboma Following Vaginal Delivery 2. 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. 3. Kaiser CW, Friedman S, Spurling KP, Slowick T, Kaiser HA: The retained surgical sponge. Ann Surg 1996; 224: 79-84. 4. Greenberg CC, Gawande AA: Beyond counting: current evidence on the problem of retaining foreign bodies in surgery? Ann Surg 2008; 247: 19-20. 5. National Quality Forum. Serious Reportable Events. Available at http:// www.qualityforum.org/Publications/2008/10/Serious_Reportable_ Events.aspx; accessed July 19, 2010.

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