RISK REFERENCE SHEET MEDICAL/SURGICAL Retained Surgical Items Retained surgical items include any tools or materials used in surgical procedures that are unintentionally left inside a patient. Retained surgical item incidents can result in significant harm to patients that may only be experienced months or years later and often result in claims being brought against hospitals, nurses and surgeons. Incidents are generally considered to be preventable and claims can be difficult to defend. The cause of these incidents is frequently an error in counting which can result from human and environmental factors. Developing and implementing effective count processes and maintaining an environment of shared accountability for the prevention of retained surgical items are key to managing this risk. COMMON CLAIM THEMES Lack of or non-compliance with policies and procedures related to surgical counts. Poor visualization/blocked view of the surgical site. Inadequate or incomplete education of healthcare providers on proper practices for preventing retained surgical items. Surgical programs with long wait lists and high patient turnover (e.g. orthopedics). Emergent surgeries. Long, complicated and multi-phased surgeries. More than one surgical procedure being performed. Patients with a high body mass index. Breakdown in team communication (e.g. fear of speaking up due to problems with hierarchy; assumptions regarding another team member’s knowledge; rushing). Intraoperative blood loss greater than 500 mL. Patient handoffs (relief) during surgery. Counts not performed for laparoscopic and minimally invasive procedures. Inadequate follow-up of items intentionally left inside the patient to be removed at a later time. Distractions during defined times throughout procedures when the sponge count should occur. Use of abbreviated counts and counting short cuts (e.g. counting folded corners). Unanticipated changes to the operative procedure resulting in changes to surgical items not being accounted for. CANADIAN CASE EXAMPLES CASE 1 – A patient underwent a total abdominal hysterectomy. Nine months later, in response to the patient’s complaints of abdominal pain, the patient had an ultrasound and a large abdominal mass was discovered. The patient underwent surgery where a large surgical pack and abscess were removed. A statement of claim was issued. Review of the first operating room report found no discrepancy of the surgical count. Opportunities for improvement were noted regarding the frequency of the count and placement of used sponges. © 2016 HIROC. For quality assurance purposes. 1 RISK REFERENCE SHEET MEDICAL/SURGICAL Retained Surgical Items CASE 2 – A patient underwent a sigmoidoscopy and polyp removal, during which a sponge was left in the patient’s pelvis. The patient expressed concern that, “something doesn’t feel right.” The patient’s complaints were dismissed until the patient developed an infection a sometime later, requiring a blood transfusion and resection of a portion of the bowel. A statement of claim was issued and the matter was found to be indefensible. Investigations show the sponge counts were not performed properly: the count sheet was incomplete; the second count was not recorded; there was a “+1” notation which resulted in an addition error; and not enough time was given to perform the counts. REFERENCES HIROC claims files. Accreditation Canada. (2015). Required organizational practices handbook 2016. Ottawa, ON. Campione, B. (2009, July). Practice pointers: Know the risk factors for retained foreign bodies. OR Nurse Journal, 3(4), 56. Canadian Medical Protective Association. (2014). The intra-operative period: Unintentionally retained surgical items. Risk Fact Sheet. Council on Surgical and Perioperative Safety. (2005). Statement on the prevention of foreign body retention in surgical wounds. ECRI Institute. (2012). The case of the missing sponge: Practice variation is culprit. Risk Management Reporter. ECRI Institute. (2012). Unintentionally retained surgical items. Operating Room Risk Management. Gawande, A. A., Studdert, D. M., Orav, E. J., Brennan, T. A., & Zinner, M. J. (2003, January). Risk factors for retained instruments and sponges after surgery. New England Journal of Medicine, 348(3), 229-235. The Joint Commission. (2013, October). Preventing unintended retained foreign objects. Sentinel Event Alert, 51. Martindell, D. (2012, September). Update on the prevention of retained surgical items. Pennsylvania Patient Safety Advisory, 9(3), 106-110. Moffatt-Bruce, S. D., Cook, C. H., Steinberg, S. M., Stawicki, S. P. (2014, August). Risk factors for retained surgical items: A meta-analysis and proposed risk stratification system. Journal of Surgical Research, 190(2), 429-436. Noble, J. (2004, March). Counting is not as easy as 1, 2, 3. Claims and Risk Management Bulletin, 32, 1-2. Stawicki, S., Moffatt-Bruce, S. D., Ahmed, H. A, Anderson, H. L., Balija, T. M., Bernescu, I…Cook, C. H. (2013, January). Retained surgical items: A problem yet to be solved. Journal of the American College of Surgeons, 216(1), 15-22. © 2016 HIROC. For quality assurance purposes. 2 RISK REFERENCE SHEET MEDICAL/SURGICAL Retained Surgical Items MITIGATION STRATEGIES Note: The Mitigation Strategies are general risk management strategies, not a mandatory checklist. Reliable Count Processes Ensure counts are conducted for every surgical procedure (including cavity, non-cavity and minimally invasive procedures) and for each caesarean section and vaginal delivery. Ensure all standard and non-standard items are counted (e.g. prepackaged sponges, towels, therapeutic packing, needles, specialized instruments that do not form part of a regular tray, items “too large/obvious” to be left behind): Prohibit the use of non-radio-opaque items and gauze smaller than 4x4 in surgical sites whenever possible; Separate sponges completely and view concurrently. Consider the use of assistive technology to supplement manual counting procedures, (e.g. bar-coding, radio frequency identification systems). Ensure counts are conducted in a consistent, logical sequence (e.g. from largest to smallest). Ensure counts are conducted at set-up and at defined times throughout a procedure including: before incision; before closure of a body cavity or wound; before a handoff during surgery; and before the patient leaves the OR/procedure area. Limit distractions and interruptions at this time. Ensure all counted items remain in the OR/procedure area until a correct count is confirmed. Ensure all instruments and sharps are inspected upon removal from the surgical site to ensure they are intact. Establish a limited set of criteria for when counts can be abbreviated or excluded (e.g. emergency situations). Ensure two healthcare professionals conduct each count; the surgical team should verbally acknowledge verification of the count. Maintain a culture which supports the questioning and challenging of potential count discrepancies by instituting teamwork/briefings/debriefings. Documentation Ensure documentation of the outcomes of every surgical count: Consider the use of standardized count sheets (and a whiteboard) that list standard items and provide space to document any non-standard items used. Ensure items or instruments added during surgery are documented on the count sheet. Ensure documentation of: The names, titles, and signatures of staff performing the counts; Any technology used and the results; Surgeon notified, actions taken and results when there is a count discrepancy; The rationale for not performing a count (e.g. emergency); The number and type of intentionally retained surgical items, and follow-up actions (e.g. write an order to remove, when to re-assess). Retain count sheets as a permanent part of the health record. Post Incident Management Establish protocols for when the final count is incorrect or if the initial count has not taken place (including conducting an x-ray prior to the patient leaving the OR/procedure area) and for when a missing item cannot be seen on x-ray (including additional monitoring, completion of an incident report, disclosure to patient, involving the risk manager). Ensure verbal communication between the radiologist and the surgeon. Establish protocols for when a previously retained surgical item is encountered during a subsequent operative procedure (including retention of item for examination, disclosure to patient, involving the risk manager). Monitoring and Measurement Implement formal strategies to help ensure consistent adherence to retained surgical item/count policies/practices (e.g. periodic chart/e-record audits, analysis of reported incidents/events, learning from medico-legal matters). Date last reviewed: March 2016 Disclaimer/Terms of Use: This is a resource for quality assurance and risk management purposes and is not intended to provide legal or medical advice. Nothing in this document is deemed to articulate any standard or required practice. Rather the goal is to provide information for health care organizations regarding risk and quality issues. The information contained in this resource was deemed accurate at the time of publication; however, practices may change without notice. Please direct questions to riskmanagement@hiroc.com. © 2016 HIROC. For quality assurance purposes. 3