The WHO's World Alliance for Patient Safety was created in response to a World Health Assembly Resolution (2002) in October 2004. The charge of the World Alliance for Patient Safety is to "raise awareness and political commitment to improve the safety of care and facilitates the development of patient safety policy and practice in all WHO Member States" (World Health Organization [WHO], 2009b). The World Alliance for Patient Safety began the "Safe Surgery Saves Lives" initiative in an effort to "reduce the number of surgical deaths across the world" (World Alliance for Patient Safety, 2009, p. 2).
This initiative has been the vehicle through which the WHO's Surgical Safety Checklist was published, the use of which has been "associated with marked improvement in surgical outcomes (WHO, 2009a). Post-operative complication rates fell by 36% on average, and death rates fell by a similar amount[horizontal ellipsis]" (Haynes et al., 2009). This article will review the 19-point checklist and provide commentary regarding the why, what, and the how of its use.
THE "WHY" OF THE WHO SURGICAL SAFETY CHECKLIST
Remember the To Err Is Human: Building a Safer Health System (Kohn, Corrigan, & Donaldson, 1999) published by the Institute of Medicine (IOM) in 1999? That is the report in which the IOM estimated that as many as 98,000 Americans die in healthcare organizations each year because of medical errors. Medical errors are often synonymous with patient safety, and patient safety in the peri-operative area is extremely important because of the fact that "[horizontal ellipsis]approximately 234 million surgeries are performed annually[horizontal ellipsis]" and "[horizontal ellipsis]studies in industrialized countries have shown a perioperative rate of death from inpatient surgery of 0.4%-0.8% and a rate of major complications of 3%-17%" (Haynes et al., 2009). That brings up the subject of the Checklist and its use in the peri-operative areas.
The Checklist was fashioned to be similar to the checklists used by pilots prior to flights. Pilots use pre-flight checklists as they prepare for takeoff so as not to rely solely on memory. In this way, important safety steps are followed for each and every flight. Likewise, important safety steps can be followed for each and every surgery when the Checklist is employed.
The Checklist has been endorsed by close to 246 health organizations from more than 40 countries in the Americas, Europe, Africa, and Asia. Seventy professional associations and 29 ministries of health and hospitals, including the American College of Surgeons, the American Society of Anesthesiologists, the American Academy of Orthopedic Surgeons, the American Academy of Otolaryngology-Head and Neck Surgery, and the Association of Perioperative Registered Nurses (AORN), support this initiative (Medical professionals worldwide endorse WHO checklist for safer surgery, 2008). The initial launch for this endeavor was June 25, 2008, at the Pan American Health Organization in Washington, DC.
According to Linda Groah, MSN, RN, CNOR, CNAA, FAAN, executive director, AORN, "This initiative is so important because it's one of the first times that we bring nurses, surgeons, and anesthesiologists together to agree on a minimum standard of care that will provide safe patient care for the surgical patient" (AORN endorses the WHO Safe Surgery Saves Lives initiative, 2008).
THE "WHAT" OF THE WHO SURGICAL SAFETY CHECKLIST
The Checklist contains 19 critical safety steps, all of which are part of three distinct Checklist phases- Sign In, Time Out, and Sign Out. Each of these phases corresponds to a definite time period in the procedure's normal flow. The Sign In phase corresponds to the period before induction of anesthesia. The Time Out phase aligns with the period after induction and before incision of the skin, and the Sign Out phase is consistent with the period during or immediately after wound closure but before the patient is removed from the operating room itself.
When reviewed, it is plain to see that the Checklist requires participation and communication by everyone on the peri-operative team and, although items on the Checklist may seem self-explanatory and even elementary to some, the capture of this data, incorporated with open dialogue, may be the reason that a complication does not occur.
THE "HOW" OF THE WHO SURGICAL SAFETY CHECKLIST
Even before the Checklist is implemented, its concept must be adopted and implemented as a standard operating procedure by the entire organization.
Overall execution of the Checklist requires a dedicated "checklist coordinator." The coordinator can be any healthcare professional participating in the surgical procedure; often, the circulating nurse serves in this capacity. The coordinator must verify that the peri-operative team has completed each task before the team advances to the next step in the checklist. This cannot be accomplished unless the coordinator has been given "permission" to do so by the team. The permission referred to here is such that it is given by all team members, including the physicians, as there may be some who remain obstinate and unwilling to participate in this initiative. If this is the case, a physician champion that wholeheartedly believes in the checklist approach might be the best avenue through which to seek buy-in for all.
PHASE 1-SIGN IN
As the name implies, "Sign In" refers to the period of time before the induction of anesthesia and consists of seven critical safety steps. This phase requires, at the very least, the presence of an anesthesia professional and member(s) of the nursing staff.
The first step is confirmation-with the patient-of the patient's identity, type of procedure, site of the procedure, and of the fact that surgical consent has been given by the patient for the procedure.
Next is the verification that the surgeon performing the procedure has marked the operative site with the appropriate marker. This is followed by the anesthesia provider attesting to the fact that the anesthesia safety check has been completed. The Implementation Manual Surgical Safety Checklist (1st ed.) notes, "[horizontal ellipsis]A helpful pneumonic is that, in addition to confirming that the patient is fit for surgery, the anesthesia team should complete the ABCDEs-an examination of the Airway equipment, Breathing system (including oxygen and inhalational agents), suction, Drugs and devices, and Emergency medications, equipment, and assistance to confirm their availability and functioning" (World Alliance for Patient Safety, 2009, p. 10).
Step 4 is the confirmation that a pulse oximeter has been placed on the patient and is functioning correctly. Then, there are steps 5, 6, and 7 when the coordinator asks the anesthesia provider three questions-whether the patient has any known allergies, has a difficult airway, or is at risk of aspiration, and whether the patient is at risk of losing more than 500 ml (7 ml/kg in children) of blood during the procedure, respectively.
Why should the coordinator ask the anesthesia provider if there are any known allergies when the information is available for the coordinator already? It is to verify that the anesthesia provider is also aware of any allergies the patient may have. What about asking about the difficult airway or the patient's risk of aspiration? This is asked to verbally confirm that an objective assessment has been conducted by the anesthesia provider and that modifications to the anesthesia plan of care and availability of adequate equipment have been made. Lastly, why ask about risk of blood loss? Again, it is to allow for adequate preparation and to mitigate the consequences of blood loss in those amounts.
With Sign In complete, the anesthesia provider may proceed with the induction of anesthesia.
PHASE 2-TIME OUT
There are also seven critical safety steps in the "Time Out." This is the phase in which the team stops to re-evaluate and confirm several safety checks before the incision is made.
The first step in the Time Out is for all of the team members to introduce themselves by name and role-the "roll call." Yes, everyone may know everyone else, but this will allow for instances in which new team members, including students being rotated into the operating room, to be recognized as well. According to Dr. Atul Gawande, a surgeon and a professor at the Harvard School of Public Health, "The 'roll call' item was added because research has shown that operating room communication problems-such as junior members of a surgical team being afraid to speak up when they see something going wrong-can have serious consequences. Giving them a chance to say their names allows them to speak up later" (Study: Simple surgical checklist saves lives, 2009).
Next is the standard Time Out, a verbal confirmation by the surgeon, anesthesia provider, and nurse that this is the correct patient, site, and procedure. To accomplish this, the coordinator might say, "Let's take our Time Out. Does everyone agree that this is patient X, undergoing a right inguinal hernia repair?" (World Alliance for Patient Safety, 2009, p. 14). Note, if the patient is not sedated, the coordinator should confirm this information as well.
There are then five "anticipated critical events" (WHO, 2009a) questions listed in the Checklist's Time Out phase. The first of these five is "Surgeon Review-What are the critical or unexpected steps, operative duration, anticipated blood loss?" (WHO, 2009a). The reason this question is asked is to bring to the forefront any steps in the procedure or patient major morbidity that may require additional preparation, implants, or equipment. Note that the last part of the question is a re-evaluation of potential blood loss.
The second question has to do with asking the anesthesia provider if there are any patient-specific concerns. In answer to this question, specific reference can be made by the anesthesia provider regarding any specific concerns of the anesthesia provider who can state that there are no specific concerns for this patient and case.
Now, it is the nursing team's turn, and they are queried regarding whether sterility indicators have been confirmed and whether there are any equipment issues or other concerns from a nursing standpoint. Of course, any issues with sterility would be addressed before the incision is made, but this is a venue that allows the nurse to speak up about problems with equipment or other preparations and also about safety concerns he or she may have for the patient. If there are no concerns, then the scrub nurse or technologist could say, "Sterility was verified. I have no special concerns" (World Alliance for Patient Safety, 2009, p. 16).
There are still two more questions to answer before this phase is complete-has antibiotic prophylaxis been given within the last 60 min and is essential imaging displayed?
If the prophylaxis antibiotic was administered more than 60 min before the case, what action is taken by the team? Should the patient be re-dosed? If the decision is made not to re-dose the patient, the Checklist box cannot be checked. If the prophylaxis is not necessary because of the fact that the case does not include a skin incision or the case is contaminated and antibiotics are already given as part of treatment and are thus "not applicable," the Checklist box can be checked.
If imaging is needed, it should be displayed correctly. If needed imaging has not been brought to the operating room, the surgeon must decide whether to proceed with the case even though the imaging is lacking. However, in the later instance, the Checklist box would be left unchecked.
After all seven critical safety steps in this phase have been asked and answered, the team is ready to move to the last phase-Sign Out.
PHASE 3-SIGN OUT
In the "Sign Out" phase, four explicit items must be verbally confirmed by the coordinator with the team immediately after wound closure, before the patient is removed from the operating room and prior to the time the surgeon leaves the operating room. The first is for the coordinator to record the procedure performed. The coordinator must then confirm that the sponge, needle, and instrument counts are correct. If the counts are not correct, immediate action should be taken to find the missing items by checking the wound, examining the drapes and garbage, or via radiographic images. At this point, the coordinator verifies that the labeling of the specimen includes all required information along with the patient's name. Fourth, the coordinator asks whether there were any equipment problems that need to be addressed.
Finally, all the team members, including surgeon(s), anesthesia provider(s), and nursing personnel, review the key concerns for the patient's recovery and future care management. This step is to ensure that critical information will be transferred to the next healthcare provider(s).
The checklist is now completed and according to the Implementation Manual, it can be placed in the patient record or retained for quality assurance review (World Alliance for Patient Safety, 2009, p. 19). The organization must determine how best to monitor how the checklist is used and the impact the checklist has on the patient it serves.
While there are always naysayers and those who consider the energy spent on completing this type of exercise as a burden or a time waster, use of the checklist has already proven to be a valuable tool that saves lives. When used as intended, this tool can only enhance the "culture of safety" already in place at virtually every organization in the country.
As can be seen, the checklist is not comprehensive, but it does provide opportunities for the team to address the critical safety steps that assist in verifying pertinent information, specifying plans, and making clear individual patient data. Each organization has the option of adding more critical safety steps to the checklist. Suggested additional steps noted in the Implementation Manual include "[horizontal ellipsis] confirmation of venous thromboembolism prophylaxis by mechanical means (such as sequential compression boots and stockings) and/or medical means (such as heparin or warfarin) when indicated, the availability of essential implants (such as mesh or a prosthetic), other equipment needs, or critical preoperative biopsy results, laboratory results, or blood type[horizontal ellipsis]" (World Alliance for Patient Safety, 2009, p. 20).
AORN endorses the WHO's Safe Surgery Saves Lives initiative, which includes the checklist. Join in the fight to save lives by adopting and implementing the checklist as soon as possible and watch the numbers of lives saved grow.