Retained Foreign Items (Surgical and Maternal/Neonatal)

Service: Risk Management
Subject: Care
Setting: Obstetrics

Retained foreign items include any tools or materials used in surgical procedures that are unintentionally left inside a patient. Retained items can cause significant harm to patients, the source of which may only be determined months or years later. These harmful occurrences often result in claims being brought against hospitals, nurses and surgeons. Such incidents are generally considered to be preventable and are therefore difficult to defend. In 2015, unintentional retained foreign item was recognized as one of Canada’s “never events” (defined as “patient safety incidents that result in serious patient harm or death that are preventable using organizational checks and balances”). [Canadian Patient Safety Institute and Health Quality Ontario. (2015)]. These incidents are frequently caused by counting errors that arise from human and environmental factors. Developing and implementing effective count processes and maintaining a culture of shared accountability for the prevention of retained foreign items are key to managing this risk. 

Common Claim Themes

Frequently involve:

  • Emergency surgeries.
  • Long, complicated and multi-phased surgeries.
  • More than one surgical procedure being performed.
  • Patients with a higher body mass index.
  • Intraoperative blood loss greater than 500 ml.
  • Surgical programs with long wait lists and high patient turnover (e.g., orthopedics).
  • Birth/perineal trauma repair after a vaginal birth.

System failures

  • Inadequate count protocols for:
    • Surgery;
    • Birth/perineal trauma repair.

Knowledge and judgement

  • Lack of or non-compliance with policies and procedures related to surgical, birth or perineal trauma repair counts.
  • Counts not performed for laparoscopic and minimally invasive procedures including birth and perineal trauma repairs.
  • Inadequate follow-up for items intentionally left inside the patient to be removed at a later time.
  • Use of abbreviated counts and counting short cuts (e.g., counting folded corners).
  • Failure to identify and remove the retained object (gauze, packing, steri-strips, non-absorbing sutures) as present in the pressure injury or wound.

Communication and documentation

  • Breakdown in team communication (e.g., fear of speaking up due to problems with hierarchy; assumptions regarding another team member’s role or knowledge; rushing).
  • Inadequate patient handoffs (relief/shift change).
  • Distractions or disruptions during defined times throughout procedures when count should occur.
  • Poor visualization or blocked view of the surgical site.
  • Unanticipated changes to the operative procedure resulting in changes to surgical items not being accounted for.
  • Failure to identify and remove the retained object as present in a pressure injury or wound (gauze, packing, steri-strips, nonabsorbing sutures). I would exclude the bracket but if it is needed, keep it a the the end.

Case Study

A surgical blade tip was left behind during an abdominal hysterectomy. The retained item was identified on a CT scan. A follow-up surgery was required to remove the item. Experts could not conclusively determine whether the item was left in following the hysterectomy or an earlier surgery. However, expert review of the care revealed that the OR nurses failed to communicate and document the final count and that it was reasonable for the surgeon to expect the nurses to do so. Experts identified that it the OR nurses should have inspected the surgical blade when it was handed over by the surgeon. Evidence of this breach of the OR nursing standard of care supported the conclusion that the blade tip was left behind during the abdominal hysterectomy. Contrary to organizational policy on retained objects, the blade tip was not retained therefore the case was indefensible.

Mitigation Strategies

Reliable Count Processes 

  • Adopt a standardized evidenced-based protocol and/or policy for performing sponge and instrument counts including (but not limited to):
    • Conducting counts for every surgical procedure (including cavity, non-cavity and minimally invasive procedures) and for each caesarean section and vaginal delivery;
    • Conducting counts 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 or procedure area;
    • Limit distractions and interruptions at this time;
    • Ensuring 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 or too obvious” to be left behind);
    • Prohibiting the use of non-radio-opaque items and gauze smaller than 4x4 in surgical sites whenever possible;
    • Separating sponges completely and view concurrently;
    • Conducting counts in a consistent, logical sequence (e.g., from largest to smallest);
    • Ensuring all counted items remain in the OR or procedure area until a correct count is confirmed;
    • Ensure all instruments, supplies and sharps are inspected upon removal from the surgical site to ensure they are intact.
  • Adopt a standardized evidence-based protocol and/or policy for performing sponge and instrument counts following all births and perineal suturing.
  • Establish a limited set of criteria for when counts can be abbreviated or excluded (e.g., emergency situations).
  • Consider the use of assistive technology to supplement manual counting procedures (e.g., bar-coding, radio frequency identification systems).
  • Implement strategies to develop and maintain an environment which supports the respectful questioning and challenging of potential count discrepancies. 

Documentation and Communication

  • Retain count sheets as a permanent part of the health record.

Strategies for surgical and maternal practitioners and teams

  • Ensure complete and timely documentation of every surgical and birth/perineal trauma count, including (but not limited to):
    • Items or instruments added during surgery;
    • 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)

Post Incident Management

  • Implement standardized protocols and decision aids 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;
    • A previously retained surgical item is encountered during a subsequent operative procedure. 

Monitoring and Measuring

  • Ensure a formal quality of care or system review is undertaken following all unintentional retained foreign object incidents.
  • Implement formal strategies to monitor and measure the effectiveness and efficiency of, and adherence to surgical count practices and documentation requirements in all surgical and maternal/neonatal settings including (but not limited to):
    • Adoption of formal quality indicators and measures;
    • Sharing learning from near-miss and harm incidents involving counts with teams (e.g., chart audits, trigger tools, incident reports, team debriefs, critical incident and quality of care committee reviews, medical legal claims).

References

  • HIROC claims.
  • AHRQ (N.D.) PDI 03: Retained surgical item or unretrieved device fragment count. Toolkit For Using AHRQ Quality Indicators: 1-6.
  • Canadian Institute for Health Information and Canadian Patient Safety Institute. (2020). Retained foreign body. Hospital Harm Improvement Resources: 2-10.
  • Canadian Institute for Health Information (2019). OECD Interactive Tool: International Comparisons. Published 2019b.
  • Canadian Medical Protective Association, Healthcare Insurance Reciprocal of Canada. (2016). Detailed analysis. Surgical safety in Canada: A 10-year review of CMPA and HIROC medico-legal data.
  • Canadian Patient Safety Institute and Health Quality Ontario. (2015). Never events for hospital care in Canada: Safer care for patients.
  • Cima RR, Kollengode A, Storsveen AS, et al. (2009). A multidisciplinary team approach to retained foreign objects. The Joint Commission Journal of Quality and Patient Safety. 35(3): 123–132.
  • Steelman, VM, Shaw S, Shine L, et al. (2018). Unintentionally retained foreign objects: A descriptive study of 308 sentinel events and contributing factors. The Joint Commission Journal on Quality and Patient Safety. 45(4): 249-258.
  • Wallace SC. (2017). Retained surgical items: Events and guidelines revisited. Pennsylvania Patient Safety Authority. 14(1):27–35.