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Prevention of Surgical Errors

Editor: Mark W. Jones Updated: 5/29/2023 12:45:30 PM

Introduction

A surgical error is an unintentional, preventable injury occurring in the perioperative period that is not considered a known acceptable risk of surgery and could have been avoided by following appropriate procedure-specific training protocols. Surgical errors are a type of medical error and include retained foreign bodies, mislabeled surgical specimens, and wrong-site, wrong-procedure, and wrong-patient errors (WSPEs). An analysis of these errors over the last few decades has revealed their cause is often multifactorial. However, miscommunication, unnecessary or emergent procedures, insufficient training, and provider burnout represent common causes of surgical error.

Medical errors pose a substantial challenge to public health. The significance of medical errors first came to light in 1999. The Institute of Medicine published a report demonstrating nearly 100,000 deaths annually due to medical errors.[1] A 2013 literature review using more recent evidence found an alarming incidence of up to 400,000 annual deaths from medical errors in hospitalized patients.[2] In 2021, the Centers for Disease Control and Prevention (CDC) recognized medical error as the fourth most common cause of death based on reported mortality when including system errors in the analysis. While some human error is inevitable, the creation of modern healthcare systems designed to decrease the frequency and mitigate the adverse outcomes of these errors continues to evolve. Knowledge of medical errors and their associated definitions and principles promotes understanding of surgical errors.

Medical Error

A medical error is defined as an unintentional act, either by omission, where an action is not taken, or commission, where the wrong action is taken. Medical errors may or may not be directly linked to adverse patient outcomes.[3] A study published in 2005 highlighted the need for a universally accepted definition of medical error to allow for appropriate data analysis, collaborative work, and assessment of the impact on overall patient outcomes in terms of medical error.[4]

Adverse Event

An adverse event is a preventable or unpreventable injury directly caused by medical management and unrelated to any underlying medical condition of the patient. The injury sustained due to the adverse event does not meet the standard of a sentinel event.[4]

Negligence

Negligence is medical care that fails to meet the standard of care as defined by the care provided by a reasonable clinician sharing similar specialty training, knowledge, and experience.

Near Miss

A near miss is an unplanned event that almost occurred and had the potential to result in patient harm. A near-miss analysis enables healthcare systems to identify and modify protocols before patient harm occurs.

Never Event

A never event, commonly referred to as a "serious reportable event," is an error in healthcare delivery that is easily identifiable and preventable and results in severe consequences to the patient. Never events identify issues in the care provided and the credibility of a healthcare facility.[4]

Sentinel Event

A sentinel event is an unexpected event, including loss of limb or death, that leads directly to severe psychological or physical harm. This type of medical error requires immediate investigation. Sentinel events include WSPEs, post-surgical and post-procedural retained foreign bodies, administration of incompatible blood products resulting in a hemolytic transfusion reaction, and treatment-related errors resulting in death, such as incorrect medication administration.[5]

Root Cause

The root cause is defined as the fundamental cause for the occurrence of an undesired outcome. Common root causes of sentinel events include but are not limited to human factors and poor communication and leadership.[6]

Function

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Function

Prevention of surgical errors aims to minimize mistakes and adverse events that may happen during the perioperative period. Surgery is a complex, high-risk medical field requiring precise coordination and execution from the surgical team. However, errors can occur at various stages of the surgical process, including during preoperative planning, patient positioning, anesthesia administration, intraoperatively, and postoperative care. Such errors can lead to complications such as bleeding, infection, tissue and organ damage, and even death. By implementing measures to prevent surgical errors, healthcare professionals aim to enhance patient safety and improve the quality of care. These measures may include standardized checklists, team training, advanced technologies, and ongoing quality improvement initiatives. 

The Joint Commission is an independent, nonprofit organization created in 1951 that accredits over 20,000 healthcare organizations in the United States. The mission of The Joint Commission is to provide quality healthcare, prevent patient harm, and improve patient advocacy. Following a review of sentinel event alerts related to wrong-site surgery in 1998, The Joint Commission made an effort to eliminate wrong-site surgery by creating National Patient Safety Goals and a Universal Protocol for Preventing WSPEs.[7] 

The Joint Commission National Patient Safety Goals

The Joint Commission National Patient Safety Goals to eliminate wrong-site surgery include:

  • Use a minimum of two patient identifiers to confirm patient identity. 
  • Identify and reduce risks to patient safety.
  • Prevent infections using hand hygiene guidelines from the CDC or World Health Organization. 
  • Ensure medical equipment is functional and alarm systems are in working order and audible. If maintenance is required, we must ensure this happens promptly.
  • Prevent mistakes in surgery by marking the correct surgical site on the patient, verifying the correct surgery is performed on the correct patient, and taking a brief pause before starting surgery to ensure an error has not been made.
  • Ensure medications are labeled correctly, perform accurate medication reconciliation, spend more time with patients on blood thinners, and provide the patient with written instructions on their medications.

The Joint Commission Universal Protocol for Preventing WSPEs

This protocol recommends conducting a preprocedural verification process, marking the procedure site, and performing a time-out before the procedure.

Conduct a Preprocedural Verification Process

  • Confirm the correct procedure, patient, and surgical site.
  • Involve the patient before receiving sedative medication if possible. This was noted to be one of the most effective steps in the protocol.[8]
  • Identify the instruments needed for the procedure.
  • Utilize a standardized list to confirm the availability of instruments needed for the procedure.

Mark the Procedure Site

  • Minimum requirements include marking the operative site if there is more than one possible location that can be operated on.
  • The operative site should be marked by the surgeon and confirmed by the patient in the preoperative holding area.
  • When surgical marking sites are anatomically difficult or impractical, use your organization’s protocol to ensure the correct surgical site is operated on.

Perform a Time-out Before the Procedure

  • A standardized time-out must be performed before making an incision or starting an invasive procedure.
  • The time-out involves introducing each member of the operative staff, such as the surgeon(s), surgical technician, anesthesia team, circulating nurse, and patient, if possible.
  • At a minimum, the surgical staff must agree on the correct patient identity, site, and procedure. Other items discussed include patient allergies, preoperative antibiotics or other medications, and the American Society of Anesthesiologists classification (ASA).
  • If a patient is undergoing multiple procedures and the provider performing the procedure changes, an additional time-out must be completed before starting the following procedure.

Clinical Significance

The clinical significance of surgical error prevention cannot be overstated. Over 300 million major surgeries are performed annually worldwide, and approximately 50 million are performed yearly in the United States.[9] Surgical errors are a continual topic of conversation due to their incidence and potentially catastrophic side effects. A systematic review of serious reportable events published in 2015 estimated one wrong-site surgery per 100,000 surgical procedures performed in the United States.[10] Another study published in 2016 reported that deaths due to medical errors were not included in death certificates or reported mortality rates in the United States, suggesting under-reporting of mortality rates due to error.[11] Surgical errors also carry a significant financial burden. Reports from the National Practitioner Data Bank, a database that gathers medical malpractice claims, reported over 9000 malpractice claims for never events totaling over $1 billion from 1990 to 2010.[12] Surgical errors can also harm the reputation of healthcare institutions and healthcare professionals.

Surgical errors can have several negative consequences for patients, including lengthier hospital stays, increased healthcare costs, and a higher risk of complications and mortality. In addition to the direct impact on patients, surgical errors can also take a significant emotional and psychological toll on patients and their families. A rarely discussed aspect of surgical error is its effect on the clinician. For example, surgical errors that cause permanent disability or death of a patient can significantly harm the mental health, work performance, and interpersonal relationships of the clinician.[13] 

Mainstream healthcare systems have created and adopted numerous strategies to mitigate surgical errors. These strategies often rely on the fundamental tenets of decreasing error frequency and increasing error detectability. Early detection of surgical errors permits the mitigation of downstream effects before patient harm occurs. Surgical error prevention strategies have gained insight from other systems, such as the United States Navy nuclear submarine program, the Federal Aviation Administration air traffic services, and nuclear power plants. These highly reliable high-risk operational organizations have achieved lower-than-expected error rates. Studies have also demonstrated that these systems share a supportive culture emphasizing effective communication, a creative work environment, trust, and attentiveness. This suggests that such a culture could improve overall patient safety within healthcare systems.[14] 

Creating a culture of safety within a healthcare system requires constant assessment and a commitment to safety throughout the entire system. An evidence-based approach to identifying organizational characteristics that promote a culture of safety will likely improve patient safety. Frequently shared characteristics include promoting error reporting behavior, easy accessibility to resources that address safety concerns, and collaboration across positional rankings to seek solutions.[15] By implementing effective strategies to prevent surgical errors, healthcare providers can improve patient outcomes, reduce healthcare costs, and enhance their reputation for delivering high-quality care. In addition, clinicians and healthcare providers should be familiar with various tools and principles created over the years to help assess workplace culture, prevent surgical errors, and enhance healthcare outcomes.

Enhancing Healthcare Team Outcomes

Preventing surgical errors is a task that requires a robust interprofessional approach. Current recommendations for addressing this global issue rely on effective communication, teamwork, and adopting a culture of safety. Lingard et al identified communication failures as a significant contributor to surgical errors; interprofessional team interventions such as checklists, briefing, and debriefing effectively reduced communication failures and, consequently, surgical errors.[16] Interprofessional team members play a critical role in enforcing validated checklists in the operating room to prevent surgical errors. Healthcare workers should continue collaborating and remain well informed about these preventative efforts to minimize potential detrimental outcomes, as surgical errors are an unavoidable aspect of healthcare. (Level III) 

Several collaborative organizations and ongoing quality improvement initiatives such as The Joint Commission, World Health Organization, Surgical Care Improvement Project, Agency for Healthcare Research and Quality, Comprehensive United-based Safety Program, and the Safety Attitudes Questionnaire have played a role in improving patient safety.

The Safety Attitudes Questionnaire (SAQ) is used in more than 500 hospitals in the United States. The SAQ is a validated tool that measures culture by establishing benchmark safety culture scores. The SAQ comprises questions measuring working conditions, job satisfaction, perception of management, safety climate, teamwork, and stress recognition. Participating institutions compare scores and work together to implement programs to improve their safety culture.[17]

Error reporting is intended to prevent future error occurrences. The Joint Commission requires healthcare agencies immediately report all sentinel events to allow for timely investigational analysis and response. Root cause analysis and failure mode effect analysis (FMEA) are two major analytical frameworks following error reporting.[18] Root cause analysis is an organized team process to identify the causes of an event that directly led to an undesired outcome, followed by solutions to prevent similar undesired outcomes in the future. The Joint Commission requires all healthcare institutions to perform a root cause analysis investigation following any reported sentinel events.[6] FMEA is a proactive, structured approach to identify and address the causes and effects of a potential problem before an adverse event occurs.[19]

Simulation training allows healthcare professionals to practice key aspects of patient care without the risk of causing harm. Evidence shows that simulation training in laparoscopic inguinal hernia repair and central line placement improves patient care outcomes.[20] Simulation training and certification are mandatory in surgical residency training across the United States to ensure appropriate surgeon competency.[21]

The Comprehensive Unit-based Safety Program (CUSP) promotes routine interprofessional meetings to discuss and improve safety hazards.[22] CUSP was first implemented in 2008 at an academic medical center that demonstrated improvements in teamwork, safety climate, and turnover rate amongst inpatient surgical nursing staff.[23] A study published in the Journal of the American College of Surgeons in 2012 demonstrated reduced surgical site infections and improved patient outcomes after implementing CUSP.[24]

The Agency for Healthcare Research and Quality (AHRQ) was created in 1989 to improve healthcare efficiency, safety, and effectiveness in the United States. The AHRQ created Patient Safety Indicators in 2003, which aid healthcare system leaders in identifying potential adverse events.[25]

The World Health Organization (WHO) Safe Surgery Saves Lives campaign was created to implement safe surgical and patient safety practices. The campaign recommends a surgical safety checklist divided into three phases: sign-in, time-out, and sign-out. These steps help to control possible errors associated with equipment, correct site, correct patient, correct procedure, antibiotic administration, sponge count, and postoperative assignment.[26] The sponge count should proceed as follows: first, count the sponges nearest the patient's incision; second, the sponges on sticks; third, the sponge on the mayo stand; and finally, the sponges on the back table. Sign-in occurs once the patient is brought into the operating room and before the induction of anesthesia. Time-out occurs before the incision is made or the start of an invasive procedure. Sign-out occurs after the procedure is complete and before the patient leaves the operating room.

The Situational Debriefing Model is a communication technique used by the US Navy that focuses on structured verbal communication. This model can be applied to standard patient sign-out in which written or oral communication of patient information is provided to the oncoming healthcare professional assuming their care. This technique can enhance the transmission of critical information such as pertinent medical history or physical examination findings, changes in underlying condition, significant concerns, and adequate time for questions from the receiving provider.[27]

The Surgical Care Improvement Project (SCIP) was created as a steering committee composed of several national organizations, including the CDC and The Joint Commission, committed to reducing surgical complications. SCIP measures the incidence of preventable perioperative adverse events by advocating using effective, up-to-date practices and removing out-of-date ineffective methods.[28]

Nursing, Allied Health, and Interprofessional Team Interventions

Interprofessional collaboration is crucial for preventing surgical errors. These interprofessional interventions include safety checklists, briefing and debriefing, error reporting, and effective communication. Nurses are essential in monitoring the patient's vital signs, administering appropriate medications and fluids, and ensuring all necessary steps are taken before and after procedures. Allied health professionals can provide expertise and technology, such as intraoperative imaging, to enhance the precision and accuracy of surgical procedures. Interprofessional team interventions, such as briefing and debriefing, can help ensure that all team members are aware of their roles and responsibilities and can identify areas for improvement to prevent errors in future procedures. By working together in this manner, nursing, allied health, team members, and other healthcare professionals can effectively reduce surgical errors and improve the quality of care for patients.

References


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