WHO Surgical Safety Checklist

In 2004, the World Health Assembly (WHA) founded the WHO Patient Safety international alliance in order to tackle issues of adverse effects in unsafe healthcare.[6] The Global Initiative for Emergency and Essential Surgical Care[7] and the Guidelines for Essential Trauma Care[8] focused on access and quality. In 2005, WHO Patient Safety began issuing Global Patient Safety Challenges, which bring together teams of specialists in order to put together clinical guidelines and tools for research that address patient safety issues, such as hand washing.[6] In January 2007, an international consultation meeting was held on the second Global Patient Safety Challenge, called Safe Surgery Saves Lives.[9] In 2004, an estimated 187 to 281 million surgeries were performed worldwide, with complications occurring in 3-22% and deaths in 0.4-0.8% of procedures; the death rate in major procedures rose to 5-10% in developing nations.[6] Pointing to the ubiquity of the use of surgery in both the developed and developing world, WHO Patient Safety aimed to meet four main problems: a lack of awareness of the issue; a lack of data on surgical complications; inconsistent use of available safety resources; and increasing complexity of surgical procedures.[10]

One of the recommendations of this Global Patient Safety Challenge was the adoption of a checklist for use in surgical procedures. As understood in common language, a checklist is a physical list of tasks to be done, with some measure of marking each item's completion (e.g. a square to be filled with a checkmark). While it is a simple intervention, the checklist has historically been used in many occupations as an organizational and as a safety tool; Atul Gawande, the Safe Surgery Saves Lives program leader, describes the influence that the checklists had on the development of the WHO Surgical Safety Checklist in his 2009 book, The Checklist Manifesto.[11] In particular, Gawande praised the impact of pilot checklists in mitigating aviation disasters, tracing their development back to disastrous test flights of the Boeing B-17 Flying Fortress.[12] Because of its increased complexity, an experienced pilot had missed a step in flight, causing a crash; however, test pilots continued to fly the plane, albeit with short checklists that "fit on an index card, with step-by-step checks for takeoff, flight, landing, and taxiing ... the kind of stuff that pilots know how to do."[12] In further testing, the B-17 was flown for 1.8 million miles without a further accident; pre-flight and emergency pilot checklists became a standard safety feature for the industry.[12] Gawande points to how checklists can be applicable in medicine by ensuring that practitioners do not skip important steps in procedures, both in complex, high-stress situations and in seemingly routine ones.[12]

In compiling what would become the WHO Surgical Safety Checklist (SSC), the Safe Surgery Saves Lives group set out three goals: simplicity, wide applicability, and measurability.[13] This drew some influence from a prior study that showed a significant decrease in central line infections following the use of a checklist that detailed the basic steps and hygiene requirements (hand-washing; avoidance of the femoral vein; use of chlorhexidine soap; use of sterile PPE and barrier drapes; and daily inspection for possible removal).[14][6]

The checklist places its nineteen items into three "phases" of a surgical procedure: sign-in (before induction of anesthesia, while the patient is still conscious); time-out (with the surgeon present, before skin incision); and sign-out, based on the Joint Commission's Universal Protocol.[15] At each of these phases, the surgical team members present stop and make sure that the corresponding safety items have been performed (or that there is a valid reason to waive that requirement for the procedure).[15] In order to avoid ambiguity in determining and documenting each step's completion, the WHO recommends that there should be only one clinician (usually a circulating nurse) in charge of marking each item on the checklist.[15]

The Safe Surgery Saves Lives group held a study across eight hospitals worldwide, comparing their surgical safety measures and complication rates both before and after each local study team introduced the WHO Surgical Safety Checklist.[28] They found that across the 3,733 surgical patients before implementation and 3,955 after, there was a significant decrease in both complication rate (11.0% to 7.0%, p<0.001) and death rate (1.5% to 0.8%, p = 0.003).[28] An independent international study at 357 hospitals located in 58 countries has demonstrated that the use of a surgical safety checklist has been associated with a 38% lower odds of 30-day death after emergency abdominal surgery compared with the same operations performed at hospitals that didn't have a checklist.[29] A subsequent analysis with additional pooled global data from 76 countries showed that checklist use was associated with a significantly lower perioperative mortality rate in emergency laparotomy, with checklist use associated with a lower 30‐day perioperative mortality (OR 0·60, 0·50 to 0·73; P < 0·001) in multivariable models.[30] Checklist use was also significantly more common in countries with a high Human Development Index (HDI) than low HDI, yet the greatest absolute benefit was seen for emergency surgery in low‐ and middle‐HDI countries. Many subsequent studies have shown improvements in both surgical outcomes and in various safety measurements, such as increased prophylactic antibiotic use.[5][31] These data have been attributed to a number of possible causes. Several studies reported improved safety as a direct result of the checklist, such unsafe conditions caught while going through items on the list, while others also reported improved safety more indirectly, such as through improved availability of antibiotics and pulse oximetry, whose absence was highlighted through use of the checklist.[5][24] In addition, many studies report improvements in safety culture, such as "more sharing of case critical information, better decision-making and team coordination, openness about knowledge gaps, and improved team cohesion."[31]

Other studies have failed to show surgical outcome improvements after the implementation of the SSC, whose causes may be indicative of the barriers to expanding its use.[5] For example, the WHO guidelines recommend starting use of the checklist through the example of individual surgical teams well-versed in its intent and procedure.[32] However, one study reported that, in one hospital, "staff understood neither why nor how the checklist could be implemented" due to a lack of training; in other studies, surgical staff were confused regarding who was intended to check off items on the SSC.[5] Some hospitals lack training in the use of the surgical "time-out" procedure.[33] Some hospitals that did successfully implement the SSC and find improved safety reported that changing the safety culture required time and effort by a "local champion" to ensure that all staff could see the benefits of the checklist.[5] As could be expected, one study found that hospitals where the checklist "'just appeared' in operating rooms one day" faced issues with buy-in from staff.[31] In addition, cultural differences caused compliance issues with certain items on the checklist, such as placing marks on the body in Thai hospitals or perceived awkwardness in introducing oneself.[24] In such cases, WHO guidelines recommend flexibility in editing the checklist to better fit local conditions.[32]

• The Joint Commission Universal Protocol was introduced in 2004 as a perioperative check to ensure the correct person, procedure, and site.[5] While not used as a written checklist in the same manner as the SSC, WHO Patient Safety integrated its "time-out" as a pause point to check for wrong person/wrong procedure/wrong site errors.
• The SURgical PAtient Safety System SURPASS checklist was introduced in the Netherlands in order to capture the 53-70% of the surgical errors that occur outside the operating room (in contrast to the SSC, which focuses on errors that occur in the OR).[5]
• In 2009, Yisrael Mordecai Safeek published the I AM FOR SAFETY checklist, which includes safety checks required by the American Society of Anesthesiologists (ASA) and Joint Commission as well as a modified version of the SSC (rewritten to correspond to a mnemonic starting with the letters "I AM FOR SAFETY".[34]