Retained Foreign Items

Retained foreign items include any tools or materials used in surgical and invasive procedures that are unintentionally left inside a client. Retained items can cause significant harm to clients, the source of which may only be determined months or years later. These occurrences often result in claims being brought against healthcare organizations, their employees and independent contractors. 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 & Health Quality Ontario, 2015)). These incidents are frequently caused by counting errors that arise from organization, environmental and team 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. 

Expected Outcomes

Adopt standardized current evidence-based surgical count and incident response protocols.

Implement formal strategies to support and enhance:
o        Effective communication of postoperative orders;
o        Retention of count sheets / records as a permanent part of the health record;
o        Safety culture in the work environment.

Adopt current best practice quality indicators for surgical / procedure counts processes.

Common Claims Themes and Contributing Factors 

Organizational

• Inadequate count protocols for:
  • Surgery;
  • Additional instruments / sponges added to procedure;
  • Vaginal birth, assisted vaginal birth, and perineal trauma repair.
• Perceived or actual systematic tolerance of unprofessional and unsafe behaviours as well as steep hierarchical culture in the perioperative and perinatal care settings,

Knowledge and Judgement  

• Lack of compliance with policies and procedures related to surgical, birth, or perineal trauma repair counts.
• Counts not performed for laparoscopic and minimally invasive procedures including vaginal births and perineal repairs.
• Inadequate follow-up for items intentionally left in to be removed at a later time.
• Use of abbreviated counts and counting short cuts (e.g., counting folded corners).

Communication 

• Inadequate client handovers (relief and shift change).
• Distractions or disruptions during counts.
• 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.

Documentation

• Pre-emptive and falsification of documentation related to counts. 
• Inconsistent documentation practices surrounding counts.

Mitigation Strategies

Count Processes

• Adopt a standardized current evidence-based surgical count protocol, that includes (but not limited to) counting practice expectations for:
  • Invasive procedures;
  • Laparoscopic, endoscopic, and minimally invasive procedures;
  • Emergency procedures and abandoned counts;
  • Items added to the sterile filed after the initial count;
  • Births (vaginal, assisted vaginal births, and caesarean) and perineal suturing (i.e., hospital and community);
  • Packing intentionally left in to be removed later;
  • Two or more procedures done consecutively;
  • Incorrect counts (Operating Room Nurses Assocation of Canada, 2023) (Alberta Health Services, 2023) (ECRI, 2022) . 

Additional Considerations

Examples of elements to consider within the standardized evidence-based surgical count protocol:

• Conducting counts for every surgical procedure (including cavity, non-cavity, and minimally invasive procedures) and for each caesarean 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 client leaves the operating room or procedure area;
• Limit distractions and interruptions during the count process;
• Ensuring all standard and non-standard items are counted;
• Prohibiting the use of non-radiopaque items and gauze smaller than 4x4cm 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 operating room 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.

• Implement a standardized response protocol for when:
  • The final count is incorrect or if the initial count has not taken place;
  • A missing item cannot be seen on X-ray;
  • A previously retained item is encountered during a subsequent procedure.
• Implement formal best practices strategies to minimize interruptions and distractions during surgical counts (Bubric, Biesbroek, Laberge, Martel, & Litvinchuk, 2021).

Safety Culture 

• Implement formal strategies to develop and maintain a work environment which supports and expects:
  • Intra- and inter-professional collaboration and collegiality;
  • Zero tolerance of intra- and inter-disciplinary bullying and intimidation;
  • Assertive and respectful questioning and challenging of unsafe practices.
• Adopt a standardized, formalized, and program-specific chain of command (escalation) protocol for the rapid escalation of unresolved care concerns or disagreements related orders, decisions, and / or unsafe practices.

Communication

• Implement formal strategies to support the effective communication of postoperative orders with respect to wound packing intentionally left by the surgical team.

Documentation 

• Implement strategies to support the retention of count sheets / records as a permanent part of the health record.

Additional Considerations

Examples of areas of improvement to consider when monitoring, measuring, and improving documentation related to counts:

• Items or instruments added during surgery or birth;
• The names, titles, and signatures of staff performing the counts;
• Any technology used for counts and the results;
• Surgeon or delivering practitioner 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 items, and follow-up actions.

Monitoring and Measurement    

• Adopt a standardized, interdisciplinary, collaborative, and evidence-based protocol for conducting quality of care reviews involving retained foreign items resulting in client harm or death (Incident Analysis Collaborating Parties, 2012) (Machen, 2023); incorporate system thinking and human factors concepts into the review process.
• Adopt standardized quality indicators for surgical / procedure counts processes.
• Incorporate learning from local, provincial, and national retained foreign item safety reviews and data into local protocols as well as staff and client education and training.

References

• Alberta Health Services. (2023, 2). Surgical Count. Retrieved May 13, 2023, from Alberta Health Services: https://extranet.ahsnet.ca/teams/policydocuments/1/clp-prov-sugical-count-ps-109.pdf
• Bubric, K. A., Biesbroek, S. L., Laberge, J. C., Martel, J. A., & Litvinchuk, S. D. (2021). Prevalence and characteristics of interruptoins and distractions during surgical counts. The Joint Commission Journal on Quality and Patient Safety, 47(9), 556-562. doi:doi.org/10.1016/j.jcjq.2021.05.004
• Canadian Patient Safety Institute & Health Quality Ontario. (2015). Never Events for Hospital Care in Canada. 
• ECRI. (2022, 7). Unintentionally Retained Surgical Items. Retrieved from ECRI: https://www.ecri.org/components/HRC/Pages/UnintentionallyRetainedSurgicalItems.aspx
• Incident Analysis Collaborating Parties. (2012). Canadian Incident Analysis Framework. Edmonton, AB.
• Machen, S. (2023, 5). Thematic reviews of patient safety incidents as a tool for systems thinking: a quality improvement report. BMJ Open Quality, 12(2), e002020.
• Operating Room Nurses Assocation of Canada. (2023, 4). The ORNAC Standards, Guidelines, and Position Statement for Perioperative Registered Nurses. Retrieved from ORNAC: http://www.ornac.ca/en/standards