This preliminary study was published in New England Journal of Medicine (Haynes AB et al: A surgical safety check list to reduce morbidity and mortality in a global population. 2009;360:491-9, January 29). The primary result was that the introduction of a 19 item surgical safety check list reduced death from 1.5% to 0.8% (a 47% reduction) and inpatient complications from 11% to 7% (a 36% reduction). Specifically there were statistically significant reductions in surgical site infection, unplanned return to the operating room, death and “any” complication. Pneumonia was not statistically significant. The study was conducted in eight hospitals selected for a diversity of economic circumstances and patient populations. The authors prospectively collected data on 3733 consecutive patients before the introduction of the check list and then on 3955 consecutive patients after the introduction of the check list. The primary end point was rate of complications including death within the first 30 days after surgery. Enrolled subjects had to be greater than 16 years of age. Patients undergoing cardiac surgery were excluded.
The check list contained the following elements:
Sign in – Before induction of anesthesia, members of the team (at minimum the nurse and an anesthesia professional) orally confirm that:
1) The patient has verified his or her identity, the surgical site and procedure, and consent.
2) The surgical site is marked or site marking is not applicable
3) Anesthesia safety check is completed
4) The pulse oximeter is on the patient and functioning
5) All members of the team are aware of whether the patient has a known allergy
6) The patient’s airway and risk of aspiration have been evaluated and appropriate equipment and assistance are available.
7) If there is a risk of blood loss of at least 500 ml (or 7 ml/kg of body weight in children) appropriate access and fluids are available. Appropriate access is defined at two peripheral intravenous catheters or a central line placed prior to incision
Time out – Before skin incision the entire team (nurses, anesthesia professionals, surgeons and any others participating in the care of the patient) orally:
1) Confirms that all team members have been introduced by name and role
2) Confirms the patient’s identity, surgical site and procedure
3) Reviews the anticipated critical events (surgeon reviews critical and unexpected steps, operative duration, and anticipated blood loss; anesthesia staff review concerns specific to the patient; nursing staff review confirmation of sterility, equipment availability, and any other concerns)
4) Confirms that prophylactic antibiotics have been administered less than 60 minutes before incision is made or that antibiotics are not indicated
5) Confirms that all essential imaging results for the correct patient are displayed in the operating room
Sign out – Before the patient leaves the operating room:
1) The nurse reviews the following items aloud with the team (name of the procedure as recorded; that the needle, sponge and instrument counts are complete or not applicable; that the specimen, if any, is correctly labeled, including the patient’s name; and whether there are any issues with equipment that need to be addressed)
2) The surgeon, nurse, and anesthesia professional review aloud the key concerns for recovery and care of the patient.
Check list training: All participants underwent training in the use of the check list prior to its introduction. This included lectures, written materials or direct guidance.
Complications examined: The complications sought were the ones used in the American College of Surgeons’ national Surgical Quality Improvement Program: acute renal failure, bleeding requiring the transfusion of 4 or more units of red cells within the first 72 hours after surgery, cardiac arrest requiring cardiopulmonary resuscitation, coma of 24 hours duration or more, deep-vein thrombosis, myocardial infarction, unplanned intubation, ventilator use for 48 hours or more, pneumonia, pulmonary embolism, stroke, major disruption of the wound, infection of the surgical site, sepsis, septic shock, the systemic inflammatory response syndrome, unplanned returned to the operating room, vascular graft failure, and death. Urinary tract infection was not considered a major complication.
Developing and adapting the WHO check list: WHO recognized that local situations may require adaption of the check list. They provide the following guidelines: the checklist should be concise, it should take no more than a minute to complete each of the three sections, each item on the checklist must be linked to a specific unambiguous action, it should be a verbal exercise, it should be collaborative, and it should be integrated with existing processes.
WHO Goals for the surgical check list:
1) The team will operate on the correct patient at the correct site.
2) The team will use methods known to prevent harm from anesthetic administration, while protecting the patient from pain.
3) The team will recognize and effectively prepare for life-threatening loss of airway or respiratory function
4) The team will recognize and effectively prepare for risk of high blood loss
5) The team will avoid inducing any allergic or adverse drug reaction known to be a significant risk for the patient
6) The team will consistently use methods known to minimize risk of surgical site infection
7) The team will prevent inadvertent retention of instruments or sponges in surgical wounds
8) The team will secure and accurately identify all surgical specimens
9) The team will effectively communicate and exchange critical patient information for the safe conduct of the operation
10) Hospitals and public health systems will establish routine surveillance of surgical capacity, volume and results.
Comments: In a June, 2008 press release (7 months before publication of this paper) the American Society of Anesthesiologists supported the WHO initiative for the “safe surgery check list”. A number of letters to the editor appeared in the May 28, 2009 issue of the New England Journal on the article. As might be expected the article created wide spread international media interest. In the “perspectives” section of The Lancet (February 14, 2009) Jeremy Laurance (health editor of The Independent, a British newspaper) commented favorably on the results as discussed by the senior author, Atul Gawande, when he gave the James Reason Inaugural Annual Lecture at London’s Royal Society of Medicine. However, Time Magazine (January 14, 2009) quotes concerns raised by Peter Pronovost who has done seminal work on the role of check lists in improving ICU outcome. Dr. Pronovost noted that covering every item on the check list after its introduction was not high (54%). He was also concerned that the decrease in complications and improved outcomes seemed too large for the interventions described. Others have wondered why the follow-up period was so short and whether or not the reported improvements were sustained. I find it interesting that the New England Journal published it as a “special article” and not as an “original article.” Finally the article describes decreased complications and death after the introduction of a check list, however it does not show how the check list as a whole or which particular parts of the check list may have had this effect. This article should be viewed as a start to an approach that may be of use in improving surgical outcomes, and not as the definitive statement on this important issue. This article, along with others, suggests that check lists should be taken seriously and not just as a chore to be dispensed with as quickly as possible.
David S. Smith, M.D., Ph.D.