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  Surgical safety checklists (SSC) can reduce surgical patient harm and improve patient safety culture in the operating suite if utilized and implemented appropriately.

The significant volume of global surgical interventions, nearly 200 million, and reports of considerable patient harm related to poor surgical safety processes have motivated endeavors to reduce these events.^1,2 Although surgical events such as wrong site/side/procedure/patient or retained foreign body are rare, malpractice payments totaling upwards of $1 billion are spent in the United States alone to mitigate preventable surgical mistakes.³ The persistence of complications despite standardized practices, such as the Universal Protocol, is alarming as well.¹ SSC have gained momentum as a safety fulcrum developed in hopes of mitigating surgical morbidity and mortality. In industries such as aviation, checklists have been aggressively utilized and now are a standard in airline safety processes. They were first adopted in the 1930s in response to a Boeing airplane crash resulting from the pilot neglecting an important but simple pre-takeoff step.⁴ The enthusiasm for checklist use has filtered into the healthcare environment as well with incorporation into successful safety schemas such as reducing catheter-related bloodstream infections.⁵

In response to growing concerns about patient safety despite over 15 years of safety-related protocols, the World Health Organization (WHO) initiated the “Safe Surgery Saves Lives” campaign in 2007. WHO Patient Safety, in conglomeration with global experts, subsequently published guidelines in 2008 and 2009 for improving the safety of surgical practice internationally. Born from these guidelines was a 19-item surgical safety checklist meant to address the majority of the 10 safety objectives defined in the guidelines.² The WHO Surgical Safety Checklist works by dividing the operative timeline into three distinct sections (see Figure 3.1).

The “sign-in” denotes the period prior to anesthesia induction where site marking, along with review of patient identifiers, procedure, and site is performed. This period also allots for a review of equipment function and preparation for blood loss, if necessary.

The “time-out” indicates the period immediately prior to incision. It is composed of a brief review of any anticipated surgical concerns and repeated confirmation of the proper patient, procedure, and site.

Lastly, the “sign-out” occurs prior to the patient’s exit from the operating theater. This is comprised of instrument and sponge counts and important details that may affect the patient’s immediate management post-operatively.

Items on the checklist are intended to elicit contribution from all operating room staff as follows; the time-out and sign-out are intended to be performed with the surgeon in the room whereas the sign-in may be performed with anesthesia and nursing staff. To assist with further execution of the surgical checklist, the WHO subsequently published an implementation manual. Instruction is provided via a step-by-step description of the checklist items and recommendations on how best to carry out review of the items through the patient’s operative course.⁶

The popularity of and exploration of checklist utilization was triggered by a 2009 publication by Haynes et al⁷ documenting significantly improved patient outcomes with checklist use. This prospective study implemented the WHO SSC at 8 income-diverse, global hospitals with a documented 47% and 36% reduction in mortality and morbidity, respectively. Further subsequent publications have confirmed improvements in surgical death and complication rates worldwide, albeit some with less robust findings.⁸ More comprehensive SSCs have also been integrated into safety protocols with improved outcomes. The SURgical PAtient Safety System checklist, or SURPASS, was utilized in the Netherlands at 6 academic and teaching hospitals over an 18-month period. This safety structure instituted the use of an extensive, but simple to follow, 12-page checklist spanning the patient’s course from admission through discharge. After implementation of the checklist, in-hospital mortality was reduced by nearly 50% with a significant reduction, by 31%, in patients with one or more complications.⁹

Criticism of the evidence to support checklist use does exist. In Haynes’ study,⁷ for example, no standard safety procedures were in place in a multitude of the sites, overall cohort mortality rates were high, and no significant reductions in measured outcomes were noted at more than half the sites. Inconsistent outcomes have generated lack of clarity regarding the value of SSCs. A more recent study from Ontario documented no reduction in mortality or surgical complications observed after the application of an SSC. The adjusted risk of death preintervention and postintervention was 0.71% and 0.65% and, for overall surgical complications, 3.86% and 3.82%.¹⁰ Similarly, a lack of reduction in mortality and early surgical complication rates has been reported in patients undergoing emergent and elective orthopedic surgery.¹¹ Aside from contradictory outcomes, the lack of randomization or controls plagues checklist literature and is a major criticism of supporting SSC use.

In efforts to address such concerns, in 2015, a modified WHO SSC was examined in a stepped wedge cluster randomized controlled trial in Scandinavia.¹² The timing of checklist implementation was randomized among 5 surgical specialties at 2 institutions. Reduction in rate of overall complications was somewhat higher, though comparable, to previous publications^7,9 with a relative risk reduction of 0.42% (95% CI, 0.33-0.50), and a significant reduction in length of hospital stay. Mortality reduction was site-specific and was significant only at the community hospital from pre-intervention of 1.9% to post-intervention of 0.2%. There was an overall reduction in mortality from 1.6% to 1.0%; however, this did not achieve significance for the cohort as a whole.

Although the observational nature of most studies motivating checklist use fuels the debate about mandated checklist use, overall, SSCs are well-endorsed worldwide.^8,10,11 Aside from outcomes data, checklist use has also been linked to improvement of team dynamic and communication amongst operative staff.^8,13,14 Impact on outcomes may also weigh heavily upon the proper implementation strategies in place to adopt and sustain the checklist. Factors such as education, proper instruction, and integration into workflow will be examined in the following chapter.

The following are essential details to be mindful of when adopting a surgical safety checklist. The case examples discussed in the following section are meant to address some of these issues and what, in fact, are the benefits and potential pitfalls to using SSCs in practice.

Case Study 3.1

The hypothesis: A surgical safety checklist may be more valuable in preventing never events than other, widely utilized protocols, such as The Joint Commission’s “Universal Protocol.”

The story: Mrs. L, a 62-year-old woman, is seen for progressive right-hand osteoarthritis in the orthopedic clinic by resident A and the surgeon. The patient complains primarily of worsening middle finger pain. She is found on exam to have bony enlargement, swelling, and mild deformity of her middle finger with mild bony enlargement and swelling of her index finger as well. Imaging reveals complete loss of articular cartilage, osteophytes and some ankylosis of the middle finger with osteophytes and mild loss of cartilage of the index finger. The surgeon diagnoses the patient with progressive osteoarthritis of the hand despite optimal pharmacologic treatment. She is reluctant to have surgery on both fingers, so after discussion with the surgeon and resident A, the decision is made to initially undergo a right middle finger DIP joint arthrodesis. Her history and physical and consent forms are filled out, and she is scheduled for surgery 3 weeks later.

Mrs. L arrives with her husband in the preoperative area the morning of her surgery. The surgeon and resident B speak with Mrs. L. The previously filled out consent and clinic paperwork is reviewed along with confirming the patient’s identity. The surgeon verbalizes that a “finger joint fusion on the right 3^rd finger” will be done. The patient also notes she accidentally closed her fingers in a door a few days earlier. A letter from the patient’s PCP reveals that her hand radiograph done in clinic did not show any acute injuries or fractures. The surgeon excuses himself in order to attend to his next hand joint fusion case. Resident B proceeds to mark the patient’s middle finger.

In the operative suite, the patient vocalizes to anesthesia, the circulating nurse, and resident A about how badly her index finger hurts and how happy she is to be getting some pain relief today. A brief review of the patient’s full name, birth date, and procedure are read aloud by the circulator nurse using the consent form. The first portion of the SSC is filled out by the nurse after confirmation with anesthesia, and the patient is anesthetized. Resident A is at the patient’s side and is reviewing the consent, the name band, and the surgical checklist as well. The patient’s right hand is prepped by the circulating nurse. A drape is applied by the scrub nurse. The resident leaves the room to scrub. The surgeon and resident A enter the room after scrubbing. Resident A applies a tourniquet to the index finger that is marked and was the site previously noted on the consent. The surgeon requests a review of the SSC. The team is familiar with the checklist given recent education by the department. The “Before Incision” section of the checklist is read aloud by the surgeon as he follows the large laminated poster board in the room. The surgeon verbalizes the patient’s procedure stating, “I am doing a right hand 2^nd finger DIP joint arthrodesis.” The circulator nurse reconfirms each item on the checklist as the review proceeds. Imaging is not visible on the screen, and the surgeon requests the circulator nurse reload the imaging. The imaging and report is then reviewed briefly by the surgeon and resident. The middle finger has more significant disease. The surgical site is inspected for surgical marking. The palmar side of the middle finger has a faint signature “Y” on it. The history and physical form is reviewed briefly by the surgeon, and it is discovered that the tourniquet has been placed on the wrong finger. The surgeon leaves the operating suite to reconfirm the middle finger site with the patient’s husband who affirms the correct, middle finger. The tourniquet is placed on the middle finger and the surgical procedure is continued.

The patient’s outcome: The patient’s surgical arthrodesis of her middle finger DIP joint was successful. Fortunately, for this patient, a potential wrong-site surgery was averted to a near-miss. The patient suffered no complications related to her surgery, and she was discharged home that evening. She underwent a successful fusion of her right index finger DIP joint by the same surgeon several months later.

What went wrong? On investigation of this case, site marking and consent were found to be problematic. The correct finger was marked, initially, however in a suboptimal location on the palmar side of the patient’s finger. The patient admitted that she had used the restroom and inadvertently washed her hands and used alcohol hand gel shortly after marking. She was certain staff would “remember” which finger was to be manipulated and thus made no mention of this. The circulator nurse did recall a “bruise” type of mark on her index finger but, admittedly, she did not examine the entire hand during application of the surgical prep solution. The OR staff did recall the patient complaining of index finger pain and thus were more-so convinced the index finger was properly marked. The surgeon, with the drape in place, stated he did notice the same slight blue-black colored mark on the top of the patient’s index finger. This was presumed to be the surgical site mark faded by the surgical prep solution. This was, in fact, a bruise from the patient’s accident a few days before. The surgeon did recall some discoloration of her hand on meeting with the patient in the preoperative area but did not recall exactly where. Unfortunately, resident B, who performed the site marking, was not in the operative suite for the case. Upon questioning, resident B noted he had reviewed the H&P and imaging prior to site marking. No other mark was visible with the patient’s hand in the surgical palmar side down position.